protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04836559 | 10.6.4 | Study Intervention Compliance | 10.6.4. Study Intervention Compliance Study intervention will be taken by the participant at home (except for the days of the study visits) (See Section 10.6.1). When feasible, the participant should start the treatment following the double-blind period with no interruption or try to keep the interruption as short as p... | [] |
NCT04836559 | 10.6.5 | Concomitant Therapy | 10.6.5. Concomitant Therapy See Section 6.5. | [] |
NCT04836559 | 10.6.6 | Recording of drug intake; overview | 10.6.6. Recording of drug intake; overview For reasons of proper PK analysis of study medication, levetiracetam/ brivaracetam and currently used some occasions the date and time of the drug intake needs to be recorded by the participant (using the subject participation card) or the investigator/site staff (using the eC... | [] |
NCT04836559 | 10.7 | Discontinuation of study intervention and participant discontinuation/withdrawal | 10.7. Discontinuation of study intervention and participant discontinuation/withdrawal Participants may withdraw from participation from the OLE period any time on their request or, at the discretion of the investigator, when JNJ-40411813 is no longer of benefit to them. A participant will be considered to have complet... | [] |
NCT04836559 | 10.8 | Study assessments and procedures for the OLE period | 10.8. Study assessments and procedures for the OLE period | [] |
NCT04836559 | 10.8.1 | Overview | 10.8.1. Overview The SoA of the OLE period (See Section 10.10) summarizes the frequency and timing of all assessments applicable to this study. Repeat or unscheduled blood samples may be taken for safety reasons, or for technical issues with the samples. Additional serum (by local laboratory) or urine pregnancy tests m... | [
"Sample Collection and Handling",
"Study-Specific Materials"
] |
NCT04836559 | 10.8.2 | Study procedures 10.8.2.1. Baseline visit | 10.8.2. Study procedures 10.8.2.1. Baseline visit For participants who continue with an interruption of 4 weeks after completing the double-blind period: - Complete the follow-up visit when the open-label period has not been started yet. - The baseline visit for the open-label period should be a new visit when visit 7 ... | [] |
NCT04836559 | 10.8.2.2 | Treatment Period | 10.8.2.2. Treatment Period During the open-label treatment period, participants must report seizures in the (e-)diary. After 1 and 2 months and every 3 months thereafter, the participant will visit the study center. The participants take the study medication at home with a meal. However, during the study visits, the su... | [] |
NCT04836559 | 10.8.2.3 | Withdrawal Visit | 10.8.2.3. Withdrawal Visit All participants who discontinue the study at any time are encouraged to complete the withdrawal visit, OLE12. The procedures to be completed during this visit are the same as during the treatment period but no new study medication will be dispensed. | [] |
NCT04836559 | 10.8.3 | Efficacy Assessments in the OLE period | 10.8.3. Efficacy Assessments in the OLE period | [] |
NCT04836559 | 10.8.3.1 | Seizure count | 10.8.3.1. Seizure count The key efficacy evaluation is seizure count; #seizures per 28 days calculated as (28/the number of days between visits)\(seizures counted between the visits). The participant and/or caregiver will be provided access to an (electronic) diary to record seizures. The e-diary will be an app downloa... | [] |
NCT04836559 | 10.8.3.2 | Retention on JNJ-40411813 therapy | 10.8.3.2. Retention on JNJ-40411813 therapy Retention of JNJ-40411813 therapy will be assessed by the time difference between the date of first dose taken in the open-label period and the date of the last dose taken. As daily dosing will not be recorded in the (e-)diary, a log in IWRS of all study intervention dispense... | [] |
NCT04836559 | 10.8.4 | Safety Assessments | 10.8.4. Safety Assessments See Section 8.4 of the protocol. | [] |
NCT04836559 | 10.8.5 | Pharmacokinetics | 10.8.5. Pharmacokinetics  During visits OLE4 to OLE7(i.c., up to 1 year after the start of the OLE period), blood samples (2mL each) for the determination of trough plasma concentrations of JNJ40411813 and metabolites (including but not limited tcSiSI) wil! be collected. SIRINNNNNNENG 0000000000 ... | [] |
NCT04836559 | 10.9 | Statistical considerations for the OLE period 10.9.1. Sample Size Determination | 10.9. Statistical considerations for the OLE period 10.9.1. Sample Size Determination The OLE extension period will be analyzed separately from the double-blind period. There is no specific sample size for this study. The study will include subjects who completed the double-blind study phase. 10.9.2. Efficacy analyses ... | [] |
NCT04836559 | 10.9.4 | Safety Analyses | 10.9.4. Safety Analyses See Section 9.3 See Section 9.4 | [] |
NCT04836559 | 10.10 | Schedule of Activities (SoA) of the OLE period | 10.10. Schedule of Activities (SoA) of the OLE period | INJ-40411813 | | | | Clinical Protocol 40411813EPY2001, Amendment INT-4 | NCT04836559 | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [
"Footnotes:"
] |
NCT04836559 | 11 | SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | 11. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | [] |
NCT04836559 | 11.1 | Appendix 1 : Abbreviations | 11.1. Appendix 1 : Abbreviations AE Adverse Event AED Anti-Epileptic Drug ALT alanine aminotransferase AMA Anti-mitochondrial antibody ANA Antinuclear antibody Anti-HAV (IgM) Anti-hepatitis A virus (Immunoglobulin M) Anti-HEV (IgM) Anti-hepatitis E virus (Immunoglobulin M) AP Alkaline phosphatase ASMA anti-smooth muscl... | [] |
NCT04836559 | 11.2 | Appendix 2: Clinical Laboratory Tests | 11.2. Appendix 2: Clinical Laboratory Tests | INJ-40411813 | | NCT04836559 | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT04836559 | 11.3 | Appendix 3: Regulatory, Ethical, and Study Oversight Considerations | 11.3. Appendix 3: Regulatory, Ethical, and Study Oversight Considerations
Regulatory Ethics Compliance
Investigator Responsibilities The investigator is responsible for ensuring that the clinical study is performed in accordance with the protocol, current ICH guidelines on Good Clinical Practice (GCP), and applicable... | [
"Regulatory Ethics Compliance",
"Investigator Responsibilities",
"Independent Ethics Committee or Institutional Review Board",
"Informed Consent",
"Privacy of Personal Data",
"Long-Term Retention of Samples for Additional Future Research",
"Country Selection",
"Administrative requirements",
"Protoco... |
NCT04836559 | 11.4 | Appendix 4: Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-up, and Reporting | 11.4. Appendix 4: Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-up, and Reporting
ADVERSE EVENT DEFINITIONS AND CLASSIFICATIONS
Adverse Event An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) produc... | [
"ADVERSE EVENT DEFINITIONS AND CLASSIFICATIONS",
"Adverse Event",
"Serious Adverse Event",
"Unlisted (Unexpected) Adverse Event/Reference Safety Information",
"Adverse Event Associated with the Use of the Intervention",
"ATTRIBUTION DEFINITIONS",
"Assessment of Causality",
"Related",
"Not Related",
... |
NCT04836559 | 11.5 | Appendix 5: Drugs to be avoided | 11.5. Appendix 5: Drugs to be avoided
Examples of Concomitant Drugs to be Avoided (Moderate or Strong Inhibitor/Inducer of CYP3A4) | inhibitors | | | inducers | |------------------------------|-------------------------|-----------------------|-------------------| | Strong inhibitors | Moderate inhibitors | Strong indu... | [
"Examples of Concomitant Drugs to be Avoided (Moderate or Strong Inhibitor/Inducer of CYP3A4)",
"Examples of substrates CCI",
"Example of substrate CCI",
"Example of PgP substrate"
] |
NCT04836559 | 11.6 | Appendix 6: Contraceptive and Barrier Guidance and Collection of Pregnancy Information | 11.6. Appendix 6: Contraceptive and Barrier Guidance and Collection of Pregnancy Information Participants must follow contraceptive measures as outlined in Section 5.1, Inclusion Criteria. In addition to the procedures described in Section 5.1, male participants must also use a condom if their female partner becomes pr... | [
"Specific considerations for the current study",
"Definitions",
"Woman of Childbearing Potential (WOCBP)",
"Woman Not of Childbearing Potential",
"premenarchal",
"postmenopausal",
"permanently sterile",
"Examples of Contraceptives",
"EXAMPLES OF CONTRACEPTIVESaALLOWED DURING THE STUDY INCLUDE:",
"... |
NCT04836559 | 11.7 | Appendix 7: Liver Safety: Suggested Actions and Follow-up Assessments | 11.7. Appendix 7: Liver Safety: Suggested Actions and Follow-up Assessments
Guideline Algorithm for Monitoring, Assessment & Evaluation of Abnormal Liver Tests in Participants with no Underlying Liver Disease and normal baseline ALT, AST, Alkaline Phosphatase and Bilirubin Although this algorithm is still applicable a... | [
"Guideline Algorithm for Monitoring, Assessment & Evaluation of Abnormal Liver Tests in Participants with no Underlying Liver Disease and normal baseline ALT, AST, Alkaline Phosphatase and Bilirubin",
"[\\\\SEE NEXT PAGE FOR TESTS AND EVALUATIONS TO BE OBTAINED ]"
] |
NCT04836559 | 11.9 | Appendix 9: Columbia Suicide Severity Rating Scale. | 11.9. Appendix 9: Columbia Suicide Severity Rating Scale.
Appendix 10a: Columbia Suicide Severity Rating Scale — Baseline-screening (Past x months = Past 6 months) | SUICIDAL IDEATION | | | | | | |--------------------------------------------------------------------------------------------------------------------------... | [
"Appendix 10a: Columbia Suicide Severity Rating Scale — Baseline-screening",
"Appendix 9b: Columbia Suicide Severity Rating Scale (Since Last Visit)"
] |
NCT04836559 | 11.10 | Appendix 10: Guidance on Study Conduct during the COVID-19 Pandemica | 11.10. Appendix 10: Guidance on Study Conduct during the COVID-19 Pandemica It is recognized that the Coronavirus Disease 2019 (COVID-19) pandemic may have an impact on the conduct of this clinical study due to, for example, self-isolation/quarantine by participants and study-site personnel; travel restrictions/limited... | [
"GUIDANCE SPECIFIC TO THIS PROTOCOL:"
] |
NCT04836559 | 11.11 | Appendix 11 : Protocol Amendment History | 11.11. Appendix 11 : Protocol Amendment History | DOCUMENT HISTORY | | | |-------------------|------------------|--| | Document | Date | | | Amendment INT-3 | 12 July 2022 | | | Amendment INT-2 | 07 April 2022 | | | Amendment INT-1 | 18 January 2021 | | | Original Protocol | 13 November 2020 | |
Amendment INT 3 (12-Ju... | [
"Amendment INT 3 (12-July-2022)",
"Overall Rationale for the Amendment:",
"To also add/clarify/correct:",
"Amendment INT-2 (07-April-2022)",
"Amendment INT-1 (18-January-2021)",
"Clinical Protocol 40411813EPY2001, Amendment INT-4",
"REFERENCESa",
"INVESTIGATOR AGREEMENT",
"Signature"
] |
NCT04854642 | 16 | APPENDICES | 16. APPENDICES | [] |
NCT04854642 | 16.1 | Study information | 16.1 Study information | [] |
NCT04854642 | 16.1.1 | Protocol and protocol amendments | 16.1.1 Protocol and protocol amendments The following documents are enclosed: - Protocol final version 1.0, 28MAY20 - Note to file, 13OCT20 - Note to file, 19JAN21 
CLINICAL STUDY PROTOCOL CRO-PK-20-345 - Sponsor code LDX0219
Influence of Food on the Oral Bioavailability of Ladarixin 200 mg Cap... | [
"CLINICAL STUDY PROTOCOL",
"Influence of Food on the Oral Bioavailability of Ladarixin 200 mg Capsule in Healthy Volunteers of Both Sexes. A Single dose (400 mg), Randomized, Open Label, Two-Way Crossover Study",
"PROTOCOL APPROVAL",
"CONFIDENTIAL",
"STUDY SYNOPSIS",
"Investigational medicinal product:",
... |
NCT04854642 | 16 | STUDY RESPONSIBLE PERSONS | 16 STUDY RESPONSIBLE PERSONS | [] |
NCT04854642 | 16.1 | Sponsor | 16.1 Sponsor Dompé farmaceutici S.p.A. - Via Campo di Pile; I-67100 L'Aquila, Italy Milan Offices: Via S. Santa Lucia 6, I-20122 Milan, Italy Phone: +39.02.583831 Fax: +39.02.58383324
Trial Manager Giuseppe Terpolilli, Pharm D. – Clinical Operations Specialist Email: giuseppe.terpolilli@dompe.com
Medical Expert Pier ... | [
"Trial Manager",
"Medical Expert",
"Drug Safety Manager"
] |
NCT04854642 | 16.2 | Institutes performing the study | 16.2 Institutes performing the study | [] |
NCT04854642 | 16.2.1 | Clinical centre | 16.2.1 Clinical centre CROSS Research S.A. – Phase I Unit, Via F.A. Giorgioli 14, CH-6864 Arzo, Switzerland Phone: +41.91.64.04.450 Fax: +41.91.64.04.451 Email: clinic@croalliance.com
Principal investigator Milko Radicioni, MD | [
"Principal investigator"
] |
NCT04854642 | 16.3 | SAE reporting | 16.3 SAE reporting Dompé farmaceutici S.p.A. Drug Safety Email: [farmacovigilanza@dompe.com](mailto:farmacovigilanza@dompe.com) Fax: +39.02.36026913 CRO: Email: [projectmanagement@croalliance.com](mailto:projectmanagement@croalliance.com) Fax: +41.91.630.05.11  | [] |
NCT04854642 | 16.4 | Drug assay | 16.4 Drug assay Bioanalytical Laboratories Dompé farmaceutici S.p.A. - Via Campo di Pile; I-67100 L'Aquila, Italy Phone: +39.0862.338323 Fax: +39.0862.338367 Mobile: +39.342.7634949 Email: franca.cattani@dompe.com
Analytics representative Franca Cattani Analytical facilities and procedures are in compliance with the g... | [
"Analytics representative"
] |
NCT04854642 | 16.5 | Centralised clinical laboratory | 16.5 Centralised clinical laboratory Unilabs Ticino, via Rovere 8, CH-6932 Breganzona, Switzerland Phone: +41.91.960.73.73 Fax: +41.91.960.73.74 Email: bmathis@unilabs.ch | [] |
NCT04854642 | 16.6 | Co-ordination, data analysis & reporting | 16.6 Co-ordination, data analysis & reporting CROSS Research S.A., Switzerland Via F.A. Giorgioli 14, CH-6864 Arzo, Switzerland
Coordination Chiara Castiglioni, Clinical Project Leader and Clinical Research Associate Email: projectmanagement@croalliance.com
Medical Writing Andrea Di Stefano, Senior Medical Writer Ema... | [
"Coordination",
"Medical Writing",
"Biometry Unit Representative",
"Quality Assurance Unit Representative"
] |
NCT04854642 | 16.7 | Provider of eCRF system | 16.7 Provider of eCRF system CROS NT SRL, via Germania 2, 37136 Verona, Italy Phone: +39. 045 820 26 66
CONFIDENTIAL  Study protocol CRO-PK-20-345 Sponsor code LDX0219 Ladarixin 200 mg capsules - food effect Final [version 1.0, 28MAY20](#page-1-0)
Responsible person Monica Pimazzoni, Director ... | [
"CONFIDENTIAL",
"Responsible person"
] |
NCT04854642 | 16.8 | Monitoring | 16.8 Monitoring Clinical Medical Services di Maria Pia Savorelli, Via Industria 5, CH-6850 Mendrisio, Switzerland Mobile: +41.79.82.72.767 Email: cmed@cmed.ch  | [] |
NCT04854642 | 17 | REFERENCES | 17 REFERENCES - 1. Dompé, Ladarixin (DF 2156A – formerly meraxin) Investigator's Brochure, final version No. 7, 09APR20 - 2. Moriconi A et al. Design of noncompetitive interleukin-8 inhibitors acting on CXCR1 and CXCR2. J Med Chem 2007; 50:3984-4002. - 3. Garau A et al. [Development of a systemically-active dual CXCR1/... | [
"Note fo File Nr. CRsS ALLIANCE CRO-PK-20-345 Issued: 130CT20 Sponsor code LDX0219 Page 1 of 1",
"Approvals:"
] |
NCT04856891 | C | o nfi de nti ality St ate me nt | C o nfi de nti ality St ate me nt T his c o nfi de ntial i nf or mati o n a b o ut a n i n vesti gati o nal pr o d uct is pr o vi de d f or t he e xcl usi ve use of I n vesti gat ors of t his pr o d uct a n d is s u bject t o r ecall at a n y ti me. T he i nf or mati o n i n t his d oc u me nt ma y n ot be discl ose d ... | [
"Investigator Protocol Agreement",
"List of Abbreviations",
"1. Protocol Synopsis",
"Nonclinical Background",
"Clinical Background",
"Clinical Background cont.",
"Target Disease Background and Rationale"
] |
NCT04856891 | R | ati o n ale f or D ose S electi o n | R ati o n ale f or D ose S electi o n T he pr o p ose d d ose re gi me n of 6 t otal d oses of 3 m g/ k g A K 0 0 2, a d mi nistere d e ver y 4 wee ks is base d o n e x perie nce wit h A K 0 0 2 i n healt h y v ol u nteers a n d i n patie nts wit h I S M, C U, se vere A C, mast cell disease, E o E, a n d E G/ E o D. T ... | [
"N u m b er of P atie nts",
"St u d y Desi g n",
"Study Design cont.",
"The study is designed as follows:",
"St u d y Desi g n c o nt.",
"Pri m ar y O bjecti ves",
"Pri m ar y O bjecti ves c o nt."
] |
NCT04856891 | S | ec o n d ar y O bjecti ves | S ec o n d ar y O bjecti ves T o f urt her c haracteriz e t he efficac y of A K 0 0 2 i n patie nts wit h E o D as meas ure d b y: - P erce nt c ha n ge i n tiss ue e osi n o p hils fr o m baseli ne t o Wee k 2 4. - Pr o p orti o n of patie nts ac hie vi n g mea n e osi n o p hil c o u nt of ≤ 1 cell/ h pf i n 3 hi g h... | [
"E x pl or at or y O bjecti ves",
"St u d y P o p ul ati o n",
"P atie nt S electi o n Criteri a",
"I n cl usi o n Criteri a",
"Patient Selection Criteria – Inclusion Criteria cont.",
"Exclusion Criteria",
"Patient Selection Criteria – Exclusion Criteria cont.",
"P atie nt S electi o n Criteri a – E x... |
NCT04856891 | T | est Pr o d u ct, D ose, a n d A d mi nistr ati o n | T est Pr o d u ct, D ose, a n d A d mi nistr ati o n A K 0 0 2 ( ) a n d place b o are s u p plie d as sterile li q ui ds a n d will be dil ute d wit h 0. 9 % Na Cl f or i ntra ve n o us i nf usi o n. T he i nf usi o n will be a d mi nistere d as s pecifie d i n t he P har mac y Ma n ual. C CI A K 0 0 2 a n d place b o... | [
"D u r ati o n of S u bject P artici p ati o n",
"S afet y E v al u ati o ns",
"Effic ac y a n d P h ar m ac o d y n a mic E v al u ati o ns",
"P h ar m ac o ki n etic a n d A nti Dr u g A nti b o d y E v al u ati o ns",
"Pharmacokinetic and Anti-Drug-Antibody Evaluations cont.",
"Sample Size Calculation"... |
NCT04864834 | A | 52-week multicenter, randomized, double-masked, 2-arm parallel study to compare efficacy, safety and immunogenicity of SOK583A1 to Eylea®, administered intravitreally, in patients with neovascular age-related macular degeneration | A 52-week multicenter, randomized, double-masked, 2-arm parallel study to compare efficacy, safety and immunogenicity of SOK583A1 to Eylea®, administered intravitreally, in patients with neovascular age-related macular degeneration Document type: Amended Protocol Version EUDRACT number: 2019-004838-41 Version number: 4... | [
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"Glossary of terms",
"Amendment 3",
"Amendment rationale",
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"Study status",
"Changes to the protocol",
"Section 10.1.3",
"Section 10.1.4",
"Section 12.1",
"Section 12.4.3",
"Section 1... |
NCT04870606 | 1 | BACKGROUND | 1 BACKGROUND
Overview of Disease Pathogenesis, Epidemiology, and Current Treatment
Epidemiology Coronavirus disease 2019 (Covid-19) emerged in late 2019 and spread rapidly, resulting in a global pandemic. New COVID-19 cases and deaths have been constantly rising. As of 20 December 2020, there have been over 75 millio... | [
"Overview of Disease Pathogenesis, Epidemiology, and Current Treatment",
"Epidemiology",
"Pathogenesis",
"Available Therapeutic Options in COVID-19",
"Role of Androgen Receptor Antagonist in COVID-19",
"Introduction to Investigational Treatment(s)"
] |
NCT04870606 | 1.2.1 | Overview of Proxalutamide (GT0918) | 1.2.1 Overview of Proxalutamide (GT0918) Compound Name: Proxalutamide Tablet (GT0918) Chemical Name: 4-[4,4-dimethyl-3-[6-[3-(2-oxazolyl) propyl]-3-pyridinyl]-5-oxo-2-thioxo-1-imidazolidinyl]-3 fluoro-2-(trifluoromethyl)-benzonitrile
Chemical Structure $$R$$ $R$ $R$ $R$ $R$ $R$ $R$ $R$ $R$ $R$ Molecular Formula: C24H1... | [
"Chemical Structure"
] |
NCT04870606 | 1.2.2 | Nonclinical Studies | 1.2.2 Nonclinical Studies | [] |
NCT04870606 | 1.2.2.1 | Nonclinical Pharmacology | 1.2.2.1 Nonclinical Pharmacology In vitro studies, GT0918 demonstrates a dual mechanism of action, i.e., highly effective in inhibiting the binding of androgen to AR as well as exhibiting pharmacological effects of inducing the downregulation of AR expression, while bicalutamide and enzalutamide did not affect AR level... | [] |
NCT04870606 | 1.2.2.2 | Anti-tumor Activity in Xenograft Models | 1.2.2.2 Anti-tumor Activity in Xenograft Models GT0918 is also effective in blocking AR signaling in breast cancer cells expressing AR. In an anti-proliferation assay, it selectively inhibited the growth of AR+ breast cancer cells such as MCF-7 and MDA-MB-453 while demonstrated no effects toward AR- breast cancer cells... | [] |
NCT04870606 | 1.2.2.3 | Safety Pharmacology and Toxicology | 1.2.2.3 Safety Pharmacology and Toxicology An in vitro cardiovascular safety pharmacology study for human ether-a-go-go-related gene (hERG) channel inhibition in CHO cells showed that GT0918 was a very weak hERG-mediated potassium channel blocker, with an IC50 much higher than 10 μM. This strongly suggests that the pot... | [] |
NCT04870606 | 1.2.2.4 | Drug Metabolism and Pharmacokinetic | 1.2.2.4 Drug Metabolism and Pharmacokinetic In vitro studies to establish the metabolite profiles of GT0918 were performed in multiple animal species including mouse, rat, dog, monkey, and human. Drug metabolism and pharmacokinetic studies were also performed in vivo in rats and dogs. Chemical inhibitor in human live m... | [] |
NCT04870606 | 1.2.2.5 | GT0918 Effect on TMPRSS2 and ACE2 Expression | 1.2.2.5 GT0918 Effect on TMPRSS2 and ACE2 Expression The spike glycoprotein plays a pivotal role in SARS-CoV-2 infection by recognizing and attaching to ACE2 transmembrane protein on host cells. The spike protein is also cleaved and activated by cell surface TMPRSS2 to facilitate membrane fusion and entry. GT0918 has s... | [] |
NCT04870606 | 1.2.3 | Clinical Studies | 1.2.3 Clinical Studies | [] |
NCT04870606 | 1.2.3.1 | Clinical Studies in Solid Tumors | 1.2.3.1 Clinical Studies in Solid Tumors Four clinical studies are ongoing in both China and the US and 3 studies conducted both in China and in US have been completed in prostate cancer and breast cancer. | [] |
NCT04870606 | 1.2.3.1.1 | Completed Clinical Studies in Solid Tumors | 1.2.3.1.1 Completed Clinical Studies in Solid Tumors
GT0918-US-1001 The US study is a Phase I/II open-label, non-randomized, dose escalation, 2-part, study in subjects with metastatic castrate resistant prostate cancer (mCRPC) who progressed after both hormonal therapy (abiraterone or enzalutamide) and chemotherapy (d... | [
"GT0918-US-1001",
"GT0918-CN-1001",
"GT0918-CN-1003"
] |
NCT04870606 | 1.2.3.1.2 | Ongoing Clinical Studies in Solid Tumors | 1.2.3.1.2 Ongoing Clinical Studies in Solid Tumors
GT0918-US-1002 The ongoing GT0918-US-1002 study was an open-label randomized, expanded/phase 2 study in subjects with metastatic hormone sensitive prostate cancer (mHSPC) or mCRPC who progressed after either Abiraterone or Enzalutamide treatment to further evaluate th... | [
"GT0918-US-1002",
"GT0918-CN-1004",
"GT0918-CN-1005",
"GT0918-CN-2001"
] |
NCT04870606 | 1.2.3.2 | Clinical Study in COVID-19 | 1.2.3.2 Clinical Study in COVID-19 A randomized, double-blinded, clinical study of GT0918 was done in Brazil for both male and female subjects with mild or moderate COVID-19 illness (NCT04446429). Two hundred and sixty-two (262) men were included in the study. 134 men were assigned to the GT0918 group and 128 men were ... | [
"Risks and Benefits"
] |
NCT04870606 | 1.3.1 | Overall Benefit-Risk | 1.3.1 Overall Benefit-Risk GT0918 dosed at 200 mg once daily has shown remarkable activity for accelerating SARS-Cov-2 clearance and decreasing the hospitalization rate significantly in subjects with mild to moderate COVID-19 illness. The clinically meaningful benefit combined with the clinically manageable safety prof... | [] |
NCT04870606 | 1.3.2 | Potential Benefits to Clinical Study Subjects | 1.3.2 Potential Benefits to Clinical Study Subjects All subjects with COVID-19 mild/moderate illness enrolled in this study will be randomized to receive GT0918 or placebo plus standard of care. The efficacy of GT0918 seen in the IIT study (NCT04446429) is highly encouraging in patients with mild or moderate COVID-19 i... | [] |
NCT04870606 | 1.3.3 | Potential Risks to Clinical Trial Subjects | 1.3.3 Potential Risks to Clinical Trial Subjects The safety profile of GT0918 is manageable. The adverse events identified with GT0918 treatment in COVID-19 were gastrointestinal AEs, including diarrhea, nausea, abdominal pain and dyspepsia. In the study for subjects with COVID-19, there were no treatment related AEs o... | [] |
NCT04870606 | 2 | RATIONALE | 2 RATIONALE | [] |
NCT04870606 | 2.1 | Study Rationale and Purpose | 2.1 Study Rationale and Purpose The glycoprotein spikes on the surface of SARS-CoV-2 utilize membrane ACE2 receptors and TMPRSS2, to enter the host cells (6). Thus, targeting the expression or activity of ACE2 or TMPRSS2 plays a critical role in reducing the pathogenicity of coronavirus infection, GT0918 can down-regul... | [] |
NCT04870606 | 2.2 | Rationale for Study Design | 2.2 Rationale for Study Design This is a randomized, placebo-controlled two-arm study with the objective to evaluate the efficacy and safety of GT0918 in outpatients with mild or moderate COVID-19 illness. The study is designed per FDA guidance [\(COVID-19: Developing Drugs and Biological Products for](https://www.fda.... | [] |
NCT04870606 | 2.3 | Rationale for GT0918 Dose and Regimen Selection | 2.3 Rationale for GT0918 Dose and Regimen Selection A dose of 200 mg was recommended based on a phase 2 study in prostate cancer with 28 days as a cycle, until disease progression. Fourteen days is used in this study to align with the standard time course of COVID-19. Based on available preliminary data from Brazil IIT... | [] |
NCT04870606 | 2.4 | Rationale for Choice of Comparator Drugs | 2.4 Rationale for Choice of Comparator Drugs Subjects enrolled in this study will either be mild or moderate COVID-19 who are not hospitalized. There are no approved treatment options for this patient population except an EUA for the investigational monoclonal antibody therapy. Bamlanivimab alone or Casirivimab and Ime... | [] |
NCT04870606 | 3 | OBJECTIVES AND ENDPOINTS | 3 OBJECTIVES AND ENDPOINTS | Objectives | Endpoints | |--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT04870606 | 4 | STUDY DESIGN | 4 STUDY DESIGN | [] |
NCT04870606 | 4.1 | Description of Study Design | 4.1 Description of Study Design This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of Proxalutamide (GT0918) in adult outpatients diagnosed with mild to moderate COVID-19. The study will be 2-arm comparison against matched placebo. The study will be co... | [
"Schema"
] |
NCT04870606 | 4.1.1 | Screening and Randomization | 4.1.1 Screening and Randomization After signing the study ICF, the screening assessments will be done within 1 day prior to randomization for selected assessments (See SoA) for the list of assessments to be performed). The investigator will review symptoms, risk factors and other inclusion and exclusion criteria to con... | [] |
NCT04870606 | 4.1.2 | Treatment Duration | 4.1.2 Treatment Duration Subject will receive treatment for 14 days, Day 1 to Day 14. From screening visit Day -1 to visit Day 28 ± 2 days post last treatment which corresponds to Day 42 Safety Follow-up visit. The scheduled procedure shown in the [Schedule of activities \(SoA\)](#page-23-1) | [] |
NCT04870606 | 4.2 | Timing of Interim Analyses and Design Adaptations | 4.2 Timing of Interim Analyses and Design Adaptations The ongoing study may be modified based on planned interim analyses. Based on the observed data at the time of the interim analyses, the study may: - suspend enrollment to GT0918 treatment arm demonstrating lack of efficacy, and/or - initiate/expand enrollment to th... | [] |
NCT04870606 | 4.3 | End of the study | 4.3 End of the study A subject is considered to have completed the study if he has completed all required phases of the study including the last scheduled procedure shown in the SoA. The end of the study is defined as the date of last scheduled procedure shown in the SoA for the last enrolled subject or last ongoing su... | [] |
NCT04870606 | 4.4 | Early Study Termination | 4.4 Early Study Termination The study can be terminated at any time for any reason by Kintor. Should this occur, the subject should be seen as soon as possible and the same assessments should be performed as described in Section 7 for a discontinued or withdrawn subjects. The investigator may be informed of additional ... | [] |
NCT04870606 | 5 | POPULATION | 5 POPULATION | [] |
NCT04870606 | 5.1 | Patient Population | 5.1 Patient Population The target population of this study are those adult subjects with mild to moderate COVID-19 illness with first positive SARS-CoV-2 virus test within 3 days, to evaluate if anti-androgen therapy may effectively prevent progression to the severe form of COVID-19 illness by treating this population ... | [] |
NCT04870606 | 5.2 | Inclusion Criteria | 5.2 Inclusion Criteria Subjects are eligible to be included in the study only if all the following criteria apply: - 1. The subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. - 2. Understand a... | [] |
NCT04870606 | 5.3 | Exclusion Criteria | 5.3 Exclusion Criteria Subjects are excluded from the study if any of the following criteria apply: - 1. Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 1.5 x ULN (upper limit of normal) and AST and ALT >3 x ULN - 4. Subjects with significant cardiovascular disease as following: - i. heart failure NYHA class ≥3 -... | [] |
NCT04870606 | 6 | TREATMENT | 6 TREATMENT | [] |
NCT04870606 | 6.1 | Study Treatment | 6.1 Study Treatment For this study, study treatment in this study refers to GT0918 in the treatment arm and placebo in the placebo arm. GT0918 will be supplied by Kintor or its designee as 100 mg tablets as individual patient supply packaged in blister. All dosages prescribed and dispensed to the patient and all dose c... | [] |
NCT04870606 | 6.1.1 | Dosing Regimen | 6.1.1 Dosing Regimen Eligible subjects will be randomized before or on Day 1 to receive either GT0918 or matched placebo. GT0918/placebo will be given 200mg orally once daily on Days 1-14 during the study period. Days 15-28 will be the post-treatment period without dosing with GT0918/placebo. The study drug will be adm... | [] |
NCT04870606 | 6.1.1.1 | General Dosing Guidelines | 6.1.1.1 General Dosing Guidelines The study treatments should be taken as follows: - Subjects should be instructed to take the study treatment of GT0918/placebo two tablets together with a glass of water once a day at the same time each day. - In general, study treatment may be taken after normal conventional meal (±2 ... | [] |
NCT04870606 | 6.1.2 | Guidelines for Continuation of Treatment | 6.1.2 Guidelines for Continuation of Treatment The treatment course continues as described above even if the subject becomes SARS-CoV-2 test negative. | [] |
NCT04870606 | 6.1.3 | Ancillary Treatments | 6.1.3 Ancillary Treatments This section is not applicable for this study. | [] |
NCT04870606 | 6.1.4 | Rescue Medication | 6.1.4 Rescue Medication This section is not applicable for this study. | [] |
NCT04870606 | 6.1.5 | Treatment Duration | 6.1.5 Treatment Duration The treatment period starts from Day 1 (first oral administration of drug or placebo) to D14, 14 consecutive days. | [] |
NCT04870606 | 6.2 | Dose Escalation | 6.2 Dose Escalation This section is not applicable for this study. No dose escalation or de-escalation is allowed through the whole study. | [] |
NCT04870606 | 6.3 | Dose Modifications | 6.3 Dose Modifications | [] |
NCT04870606 | 6.3.1 | Dose Discontinuation | 6.3.1 Dose Discontinuation Any subject who develops ≥ Grade 3 treatment emergent adverse events that are possibly, probably or definitely related to the study drug as assessed by the investigator will discontinue the treatment. There is no dose interruption or dose reduction in this study. The treatment course should b... | [] |
NCT04870606 | 6.3.2 | Follow-Up for Toxicities | 6.3.2 Follow-Up for Toxicities Subjects, whose treatment is permanently discontinued due to an AE must be followed up at least twice a week if applicable (or more frequently if required by institutional practices, or if clinically indicated) for 4 weeks or until resolution or stabilization of the event, whichever comes... | [] |
NCT04870606 | 6.3.3 | Anticipated Risks and Safety Concerns of the Study Treatment | 6.3.3 Anticipated Risks and Safety Concerns of the Study Treatment Appropriate eligibility criteria and stopping rules are included in this protocol. Recommended guideline for supportive treatment for expected toxicities, including management of study drug induced AEs are provided in [Section 6.3.2.](#page-48-8) More a... | [] |
NCT04870606 | 6.4 | Concomitant Medications | 6.4 Concomitant Medications In general, the use of any concomitant medication/therapy deemed necessary for the care of the subject is permitted, except when specifically prohibited. The subject must be told to notify the investigational site about any new medication he takes after the start of study treatment. All medi... | [] |
NCT04870606 | 6.4.1 | Permitted Concomitant Therapy | 6.4.1 Permitted Concomitant Therapy
Prior Treatment for Indication Any prior therapy, such as antivirals, antibiotics, or antimalarials used as treatment prior to signing informed consent should be recorded. Therapy prior to enrollment with antivirals including lopinavir/ritonavir, remdesivir, or other therapeutic age... | [
"Prior Treatment for Indication",
"Concomitant Therapy During the Study"
] |
NCT04870606 | 6.4.2 | Prohibited Concomitant Therapy | 6.4.2 Prohibited Concomitant Therapy Strong CYP3A enzyme inhibitors and inducers and P-gp transporter inhibitors and inducers are prohibited. Any medicine or treatment may influence evaluation of efficacy of study drug is prohibited, Spironolactone, anti-androgen drug or treatment including but not limited to 5α-Reduct... | [] |
NCT04870606 | 6.4.3 | Concomitant Therapy to Be Used with Caution | 6.4.3 Concomitant Therapy to Be Used with Caution Concomitant treatment of GT0918 with weak inhibitors or inducers of CYP3A4 is permitted. Caution is advised when GT0918 is co-administered with drugs that are moderate/strong inhibitors or inducers of CYP3A4. Duration of concomitant treatment should be kept as short as ... | [] |
NCT04870606 | 6.5 | Patient numbering, Treatment Assignment or Randomization | 6.5 Patient numbering, Treatment Assignment or Randomization | [] |
NCT04870606 | 6.5.1 | Patient numbering | 6.5.1 Patient numbering Each subject will be assigned with unique number after signing off the inform consent form, which is the screening number, composite with site number 001 and subject number 001, 002…. After the screened subject is confirmed eligible to randomization, the screen number will service as the randomi... | [] |
NCT04870606 | 6.5.2 | Treatment Assignment or Randomization | 6.5.2 Treatment Assignment or Randomization All subjects will be centrally randomized to study intervention using an interactive web response system (IWRS). Before the study is initiated, the log-in information and directions for the IWRS will be provided to each site. Subjects will be stratified by sex, race/ethnicity... | [] |
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