protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03559751 | 13.1.3 | Subject Informed Consent | 13.1.3. Subject Informed Consent An investigator (or authorized designee) will ensure that the subject (or the subject's legal representative) is given full and adequate oral and written information about the nature, purpose, potential and possible risks and benefits of the study. Each prospective subject will receive ... | [] |
NCT03559751 | 13.2 | Privacy and Confidentiality | 13.2. Privacy and Confidentiality An investigator is responsible for complying with applicable privacy regulations, per his or her jurisdiction. Only information identified in this protocol will be collected. The information collected will only be used for the purposes identified in this protocol. To ensure anonymity a... | [] |
NCT03559751 | 13.3 | Study and Site Closure | 13.3. Study and Site Closure Upon completion of the study, all study data will be provided to the Sponsor following review of site study records for completeness, and data clarifications and resolutions. Accounting, reconciliation, and final disposition of used and unused study products will be performed, as applicable... | [] |
NCT03559751 | 13.4 | Regulatory Documents and Records Retention | 13.4. Regulatory Documents and Records Retention An investigator is responsible for creating and/or maintaining all study documentation required by 21 CFR 50, 54, 56 and 312, ICH E6 section 8, as well as any other documentation defined in the protocol or CSA. An investigator must provide key documents to the Sponsor pr... | [] |
NCT03559751 | 13.5 | Delegation of Responsibilities and Adequate Resources | 13.5. Delegation of Responsibilities and Adequate Resources An investigator should have adequate time to conduct the study properly and should have an adequate number of qualified staff to assist with the conduct of the study. Version: Amendment 1.0, 2.0, 11APR2018 Page 56 of 65 The term "investigator" used throughout ... | [] |
NCT03559751 | 13.6 | Protocol Amendments | 13.6. Protocol Amendments Approval of a protocol amendment by an investigator's IRB must be obtained before implementation of the protocol amendment, unless a change is necessary to eliminate an apparent immediate hazard to the subject or when the change involves logistical or administrative aspects of the study. The p... | [] |
NCT03559751 | 13.7 | Financial Disclosure | 13.7. Financial Disclosure Clinical investigators are required to provide financial disclosure information for the submission of certification or disclosure statements required under 21 CFR § 54. As defined in 21 CFR § 54.2, a clinical investigator is a listed or identified investigator or sub-investigator who is direc... | [] |
NCT03559751 | 14 | SPONSOR APPROVAL PAGE | 14. SPONSOR APPROVAL PAGE
EVALUATION OF THE ABUSE LIABILITY OF VLN CIGARETTES IN ADULT SMOKERS | Version:Amendment 1.0, 2.0 | | |-----------------------------------------------------|------| | Date: 11APR2018 | | | 22nd Century Group, Inc. | | | | | | | | | | | | | | | James SwaugerSVP Science and Regulatory Affairs |... | [
"EVALUATION OF THE ABUSE LIABILITY OF VLN CIGARETTES IN ADULT SMOKERS"
] |
NCT03559751 | 15 | INVESTIGATOR PROTOCOL AGREEMENT PAGE | 15. INVESTIGATOR PROTOCOL AGREEMENT PAGE
EVALUATION OF THE ABUSE LIABILITY OF VLN CIGARETTES IN ADULT SMOKERS | Version:Amendment 1.0, 2.0 | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------... | [
"EVALUATION OF THE ABUSE LIABILITY OF VLN CIGARETTES IN ADULT SMOKERS"
] |
NCT03559751 | 16 | REFERENCES | 16. REFERENCES Benowitz NL, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Nicotine and carcinogen exposure with smoking of progressively reduced nicotine content cigarette. Cancer Epidemiol Biomarkers Prev. 2007 Nov;16(11):2479-85. Benowitz NL, Dains KM, Dempsey D, Herrera B, Yu L, Jacob P 3rd. Urine nicotine m... | [] |
NCT03559751 | 17 | APPENDICES | 17. APPENDICES | [] |
NCT03559751 | 17.1 | Summary of Blood Volume Requirements | 17.1. Summary of Blood Volume Requirements | | Pharmacokinetic | | Safety | | | | | | | | | | | |--------------------------------|-----------------|-----------------------|---------------------------------------|------------|-------|--|--|--|--|--|--|--|--| | | Sampling | ClinicalChemistry | Hematology | Serology | Tot... | [] |
NCT03559751 | 17.2 | Pharmacodynamic Measures/Scales | 17.2. Pharmacodynamic Measures/Scales | [] |
NCT03559751 | 17.2.1 | Tobacco/Nicotine Withdrawal Questionnaire | 17.2.1. Tobacco/Nicotine Withdrawal Questionnaire
VAS Tobacco/Nicotine Withdrawal Scale c Note: Each question will be paired with a VAS. The VAS anchored with "Not at All" on the left and "Extremely" on the right. Subjects place a vertical line at a place along the VAS based on how he feels in the moment. ![](page62Fi... | [
"VAS Tobacco/Nicotine Withdrawal Scale c"
] |
NCT03559751 | 17.2.2 | Direct Effects of Product Questionnaire | 17.2.2. Direct Effects of Product Questionnaire
Direct Effects of Product Questionnaire \ Note: Each question will be paired with a VAS. The VAS anchored with "Not at All" on the left and "Extremely" on the right. Subjects place a vertical line at a place along the VAS based on how he/she feels in the moment. ![](page... | [
"Direct Effects of Product Questionnaire \\"
] |
NCT03559751 | 17.2.3 | Use the Product Again Questionnaire | 17.2.3. Use the Product Again Questionnaire
Use the Product Again Questionnaire (Bipolar VAS)\® Please respond to the following statement based on your experience with the product you used today. Definitely Would Not Don't Care Definitely Would If given the opportunity, I would want to use this product again. ![](page... | [
"Use the Product Again Questionnaire (Bipolar VAS)\\®"
] |
NCT03654274 | 16.1 | Study Information | 16.1 Study Information | [] |
NCT03654274 | 16.1.1 | Protocol and Protocol Amendments | 16.1.1 Protocol and Protocol Amendments [Protocol Original](#page-1-0) [Protocol Amendment 1](#page-106-0) [Protocol Amendment 1 Summary of Changes](#page-215-0) [Protocol Amendment 2](#page-220-0) [Protocol Amendment 2 Summary of Changes](#page-336-0) [Protocol Amendment 3](#page-373-0) [Protocol Amendment 3 Summary o... | [
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"CONFIDENTIALITY STATEMENT",
"SPONSOR SIGNATURE PAGE",
"INVESTIGATOR STATEMENT",
"LIST OF ABBREVIATIONS",
"1. PROTOCOL SYNOPSIS",
"Secondary Efficacy Objectives",
"Safety Objectives",
"Pharmacodynamic Objective",
"Exploratory Objective",
"Study Design",
"Inclusion/Ex... |
NCT03654274 | F | or q uesti o ns o n Seri o us A d verse E ve nt/ A d vers e E ve nt of Cli nic al I nterest re p orti n g, ple ase c all: | F or q uesti o ns o n Seri o us A d verse E ve nt/ A d vers e E ve nt of Cli nic al I nterest re p orti n g, ple ase c all: - N ort h/ S o ut h A merica: P P D - E ur o pe, Asia- Pacific, a n d Africa: see r e gi o n -s pecific p h o ne n u m bers acc o m pa n yi n g t he Safet y R e p orti n g F or m T he i nitial re ... | [
"7. 7. St u d y Dr u g O ve r d ose M a n a ge me nt",
"7.8. Pregnancy Reporting",
"7.9. Vital Signs, Physical Examinations, Clinical Laboratory Tests, Electrocardiograms, and Bone Mineral Density Measures",
"7.10. Benefit/Risk Assessment",
"8. DATA QUALITY ASSURANCE",
"8.1. Clinical Procedures",
"8.2. ... |
NCT03654274 | F | or q uesti o ns o n Seri o us A d verse E ve nt/ A d vers e E ve nt of Cli nic al I nterest re p orti n g, ple ase c all: | F or q uesti o ns o n Seri o us A d verse E ve nt/ A d vers e E ve nt of Cli nic al I nterest re p orti n g, ple ase c all: - N ort h/ S o ut h A merica: P P D - E ur o pe, Asia- Pacific, a n d Africa: see r e gi o n -s pecific p h o ne n u m bers acc o m pa n yi n g t he Safet y R e p orti n g F or m T he i nitial re ... | [
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"7.9. Vital Signs, Physical Examinations, Clinical Laboratory Tests, Electrocardiograms, and Bone Mineral Density Measures",
"7.10. Benefit/Risk Assessment",
"8. DATA QUALITY ASSURANCE",
"8.1. Clinical Procedures",
"8.2. Monitoring",
"9. STAT... |
NCT03654274 | U | RI N G H E A S T E E K S E C A U S E F O U R N D O M E T RI O SI S O W F T E N A V E O U ... | U RI N G H E A S T E E K S E C A U S E F O U R N D O M E T RI O SI S O W F T E N A V E O U ... | | | Never | Rarely | Sometimes | Often | Always | |---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT03654274 | U | RI N G H E A S T E E K S E C A U S E F O U R N D O M E T RI O SI S O W F T E N A V E O U ... | U RI N G H E A S T E E K S E C A U S E F O U R N D O M E T RI O SI S O W F T E N A V E O U ... Pl e a s e v erif y t h at y o u h a v e c h e c k e d o n e b o x f or e a c h q u e sti o n b ef or e m o vi n g o n t o t h e n e xt p a g e. | [] |
NCT03654274 | U | RI N G H E A S T E E K S E C A U S E F O U R N D O M E T RI O SI S O W F T E N A V E O U ... | U RI N G H E A S T E E K S E C A U S E F O U R N D O M E T RI O SI S O W F T E N A V E O U ... | | | Never | Rarely | Sometimes | Often | Always | |---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [
"Appendix 4. European Quality of Life Five-Dimension Five-Level Scale",
"Appendix 5. Patient Global Impression of Change and Patient Global Assessments",
"Patient Global Impression of Change (Dysmenorrhea)",
"Patient Global Impression of Change (Nonmenstrual Pelvic Pain)",
"Patient Global Impression of Chan... |
NCT03695094 | 1 | SUMMARY | 1 SUMMARY Padsevonil (PSL; previously known as UCB0942) is a novel chemical entity with selective dual synaptic vesicle protein 2 (SV2) and central benzodiazepine receptor (cBZR) site affinity. It is currently being investigated for the treatment of focal-onset seizures in adult patients with drug-resistant epilepsy. M... | [] |
NCT03695094 | 2 | INTRODUCTION | 2 INTRODUCTION | [] |
NCT03695094 | 2.1 | Background | 2.1 Background More than 50 million people worldwide suffer from epilepsy. The prevalence in the UK is estimated to be 600,000 (JECUI, 2011; WHO, 2018). A population-based study conducted in Western Europe estimated that 22.5% of all patients had drug-resistant epilepsy (Picot et al, 2008). Another population-based stu... | [] |
NCT03695094 | 2.2 | Clinical studies and adverse event profile | 2.2 Clinical studies and adverse event profile As of 01 May 2018, PSL has been administered in 9 completed human Phase 1 pharmacology studies (N01360, N01383, N01386, UP0001, UP0002, UP0010, UP0013, UP0036, and UP0039) and 1 completed Phase 2 proof of concept study (EP0069). There is also 1 ongoing Phase 1 clinical pha... | [] |
NCT03695094 | 2.3 | Risk assessment | 2.3 Risk assessment Safety pharmacology studies have shown no major adverse effects on the respiratory system and CNS when administered orally in single-dose safety pharmacology studies (rats) and in repeat dose toxicity studies (rats, dogs). A slight prolongation of QTc (≤10%) was found in a 4-week study in dogs and a... | [] |
NCT03695094 | 2.3.1 | Cardiovascular events | 2.3.1 Cardiovascular events In the 39-week dog toxicity study, subtle cardiac microscopic findings, consisting of minimal valvular inflammatory cell infiltration, or minimal to slight epithelial inflammation/fibroplasia of the epicardium in the right atrium, were seen in the heart of one-third of treated dogs without d... | [] |
NCT03695094 | 2.3.2 | Psychiatric events anyent | 2.3.2 Psychiatric events anyent The occurrence of acute psychiatric serious adverse events (SAEs) (delirious syndrome, mania-like symptoms, and acute psychosis) in 3 study participants administered PSL highlights the need to maintain vigilance for such events. Reported acute psychiatric effects are consistent with adve... | [] |
NCT03695094 | 2.3.3 | Interactions with other medicinal products | 2.3.3 Interactions with other medicinal products The preclinical pharmacology studies indicated that the metabolism of PSL may be affected by extrinsic influences on the CYP3A4/CYP2C19 pathway. In order to mitigate any risk caused by Confidential Page 17 of 69 these interactions, medication or dietary ingredients that ... | [] |
NCT03695094 | 2.3.4 | Pregnancy and lactation | 2.3.4 Pregnancy and lactation Padsevonil is neither teratogenic nor embryotoxic in rats and rabbits. There was no effect on reproductive organs, including sperm analysis, following long-term administration (up to 26 weeks in rats and 39 weeks in dogs). Padsevonil has not been studied in pregnant or lactating women, and... | [] |
NCT03695094 | 2.4 | Urgent safety measures | 2.4 Urgent safety measures In accordance with UK Law (Medicines for Human Use [Clinical Trials] as amended: SI 1031 Part 4 Section 30), the sponsor and Investigator may take appropriate urgent safety measures in order to protect the study participants of a clinical study against any immediate hazard to their health or ... | [] |
NCT03695094 | 3 | STUDY OBJECTIVES S | 3 STUDY OBJECTIVES S | [] |
NCT03695094 | 3.1 | Primary objective | 3.1 Primary objective The primary objective of this study is to evaluate the effect of stable coadministered OXC (as monotherapy or adjunctive therapy) on the PK of PSL in study participants with epilepsy compared with study participants co-medicated with stable doses of LEV, LTG, or BRV therapy. REDACTED imarketingeva... | [] |
NCT03695094 | 3.2 | Secondary objectives any objec | 3.2 Secondary objectives any objec The secondary objectives of this study are to: - x Evaluate the plasma concentrations of MHD (circulating metabolite of OXC) before, during, and after administration of repeated doses of PSL to nistr support thi ma con rati - x Evaluate the effect of stable coadministered OXC (as mono... | [] |
NCT03695094 | 3.3 | Exploratory objectives | 3.3 Exploratory objectives The exploratory objectives of this study are to: x Evaluate the plasma concentrations of LTG, LEV, and BRV before, during, and after administration of repeated doses of PSL. (Blood samples for plasma concentrations of LEV, Confidential Page 18 of 69 LTG, and BRV samples will be collected and ... | [] |
NCT03695094 | 4 | STUDY VARIABLES | 4 STUDY VARIABLES | [] |
NCT03695094 | 4.1 | Pharmacokinetic variables | 4.1 Pharmacokinetic variables | [] |
NCT03695094 | 4.1.1 | Primary pharmacokinetic variables | 4.1.1 Primary pharmacokinetic variables The primary PK variables will comprise Cmax, tmax, AUCτ, and CL/Fss obtained from the plasma concentration-time profiles for PSL: application rs)and any extensions d from - x Cmax: maximum observed plasma concentration - x tmax: time of maximum concentration - x AUCτ: area under ... | [] |
NCT03695094 | 4.1.2 | Secondary pharmacokinetic variables var COPY | 4.1.2 Secondary pharmacokinetic variables var COPY The secondary PK variable will be the trough plasma concentration of MHD (OXC metabolite) before, during, and after dosing to steady state with PSL. REDACTED c v ugh pla pl y state stat authorization riable asma te with Additionally, the secondary PK variables for PSL ... | [] |
NCT03695094 | 4.1.3 | Other pharmacokinetic variables anycok kin | 4.1.3 Other pharmacokinetic variables anycok kin The following other PK variables will be assessed during the study: bles - x Trough plasma concentrations of LEV, LTG, or BRV before, during, and after dosing to steady state with PSL to h P support riabl ncentra - x Comparison of plasma concentrations from MITRA microsa... | [] |
NCT03695094 | 4.2 | Safety variables cannot | 4.2 Safety variables cannot | [] |
NCT03695094 | 4.2.1 | Secondary safety variables .1 | 4.2.1 Secondary safety variables .1 The following secondary safety variables will be assessed during the study: This document The x Incidence of AEs and SAEs | [] |
NCT03695094 | 4.2.2 | Other safety variables | 4.2.2 Other safety variables The following other safety variables will be assessed during the study: x Changes in vital signs (pulse rate [PR], respiratory rate [RR], SBP, and DBP) - x Changes in clinical laboratory test results (hematology, serum chemistry, and urinalysis) - x Changes in 12-lead ECG parameters - x Phy... | [] |
NCT03695094 | 5 | STUDY DESIGN | 5 STUDY DESIGN | [] |
NCT03695094 | 5.1 | Study description | 5.1 Study description This is a Phase 1, multicenter, open-label study in study participants with epilepsy, to evaluate the effect of OXC on the PK and safety and tolerability of PSL. or variations uate thereof. A total of 28 study participants will be evaluated in the following 2 groups (14 study participants per grou... | [] |
NCT03695094 | 5.2 | Study Periods riod | 5.2 Study Periods riod | [] |
NCT03695094 | 5.2.1 | Screening Period support ing Pe | 5.2.1 Screening Period support ing Pe The Screening Period consists of a single Screening Visit, which will be conducted at the unit within 28 days prior to check-in for the Treatment Period, and a Baseline Visit, which will be conducted at the unit 1 day prior to the Treatment Period. nt nube used prior the un to od c... | [] |
NCT03695094 | 5.2.1.1 | Screening Visit (Day -28 to Day -2) | 5.2.1.1 Screening Visit (Day -28 to Day -2) Study participants are required to sign a written Informed Consent form (ICF) prior to the conduct of any study-related procedure. Screening assessments will be conducted, after which the eligibility of study participants will be determined based on: inclusion and exclusion c... | [] |
NCT03695094 | 5.2.1.2 | Baseline Visit (Day -1) | 5.2.1.2 Baseline Visit (Day -1) At the Baseline Visit, study participants will check in at the unit the afternoon prior to the visit and receive a study participant Identification Card. extensions n prio The following procedures/assessments will be repeated: inclusion/exclusion criteria verification; medical history; f... | [] |
NCT03695094 | 5.2.2 | Treatment Period | 5.2.2 Treatment Period The Treatment Period consists of 3 days of dose titration (Day 1, Day 2, and Day 3), 4.5 days of PSL maintained at a stable dose (Days 4 through 7 and the morning of Day 8), and 4.5 days of dose taper (evening of Day 8 and Days 9 through 12). any e (D D marketing tudy days Day The dose titration ... | [] |
NCT03695094 | 5.2.3 | Safety Follow-Up Period | 5.2.3 Safety Follow-Up Period Study participants will be discharged on Day 13 and return for an End of Study (EOS) Visit on Day 20±1. The SFU Period consists of discharge from the unit on Day 13 and an EOS Visit performed on Day 20±1 or upon discontinuation of the study. Study participants will have the following proce... | [] |
NCT03695094 | 5.3 | Pharmacokinetic sampling | 5.3 Pharmacokinetic sampling Study participants will undergo serial blood sampling to measure plasma concentrations of PSL, PSL metabolites ( and ), and OXC metabolite (MHD), as well as safety monitoring. Blood samples for plasma concentrations of LEV, LTG, and BRV samples will be collected and stored during the study;... | [] |
NCT03695094 | 5.3.1 | Venous blood | 5.3.1 Venous blood Venous blood samples for PK analysis will be collected as follows: ollecCOPY ization cted a - x Padsevonil and PSL metabolites ( and ): TED co CTE horiz - prior to the morning dose of PSL on Day 1 through Day 7 and Day 9 through Day 13 REDACT SL autho - prior to the morning dose of PSL and 0.25h, 0.5... | [] |
NCT03695094 | 5.3.2 | Microsamples of capillary blood support ample | 5.3.2 Microsamples of capillary blood support ample Samples for PK of PSL from a finger skin prick will be collected using the MITRA device, as close to the conventional PK sampling as possible, at each of the time points identified for the venous blood samples for Day 8 in Section 5.3.1. be used venti samp to PSL tion... | [] |
NCT03695094 | 5.4 | Study duration per study participant | 5.4 Study duration per study participant The maximum total duration of the study is 49 days (7 weeks) for each study participant, including the Screening Period (up to 28 days), Treatment Period (12 days), and the SFU Period (maximum of 9 days). (max cannot maxim ludin The end of the study is defined as the date of the... | [] |
NCT03695094 | 5.5 | Planned number of study participants and sites | 5.5 Planned number of study participants and sites A total of 28 evaluable study participants are planned to be enrolled at a minimum of 2 sites. If a study participant drops out before completing the key assessments (ie, the full PK profile on Day 8), the study participant will be replaced. er thereof. | [] |
NCT03695094 | 5.6 | Anticipated regions and countries | 5.6 Anticipated regions and countries This study will be conducted in the Netherlands, Bulgaria, and Germany (and potentially other countries in Europe). This document cannot be used to support any marketing authorization application and any extensions or variations REDACTED COPY | [] |
NCT03695094 | 5.7 | Schedule of study assessments | 5.7 Schedule of study assessments The schedule of assessments is presented in Table 5-1. Confidential Page 23 of 69 UCB 08 June 2018 Clinical Study Protocol Padsevonil UP0070 thereof. 08 Table 5-1: Schedule of study assessments | | | | | | | | ns | | |--------------------------------------------------------------------... | [] |
NCT03695094 | 5.8 | Schematic diagram | 5.8 Schematic diagram The study schematic diagram for UP0070 is presented in Figure 5-1.
Figure 5-1: Schematic diagram  variati  bid=twice daily; BRV=brivaracetam; LEV=levetiracetam; LTG=lamotrigine; OXC=oxcarbazepine PK=pharmacokinetic(s); PSL=Padsevonil; SFU=Safety Fol... | [
"Figure 5-1: Schematic diagram"
] |
NCT03695094 | 5.9 | Rationale for study design and selection of dose tudy | 5.9 Rationale for study design and selection of dose tudy In an earlier study (UP0002), carbamazepine (CBZ, a strong CYP3A4 inducer) was demonstrated to reduce PSL exposure by >80% compared with a control group where coadministration of non-inducing AED drugs (LEV/LTG) had no impact on PSL exposure. Oxcarbazepine is a ... | [] |
NCT03695094 | 6 | SELECTION AND WITHDRAWAL OF STUDY PARTICIPANTS | 6 SELECTION AND WITHDRAWAL OF STUDY PARTICIPANTS | [] |
NCT03695094 | 6.1 | Inclusion criteria | 6.1 Inclusion criteria To be eligible to participate in this study, all of the following criteria must be met: - 1. An Independent Ethics Committee (IEC) approved written ICF is signed and dated by the study participant. variations - 2. Study participant is considered reliable and capable of adhering to the protocol (e... | [] |
NCT03695094 | 6.2 | Exclusion criteria | 6.2 Exclusion criteria Study participants are not permitted to enroll in the study if any of the following criteria is met: - 1. Study participant has previously received the IMP administered in this study. - 2. Study participant has participated in another study of an investigational medication (or a medical device) w... | [] |
NCT03695094 | 13 | Study participant has either: | 13. Study participant has either: - >2.0x upper limit of normal (ULN) of any of the following: - ALT - AST - ALP
-OR- ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If study participant has elevations only in total bilirubin that are >ULN and ULN for ALT, AST, ALP, or total bilirubin, a ba... | [
"-OR-",
"6.3 Withdrawal criteria",
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"6.4.1 Individual study participants",
"6.4.2 All study dosing",
"6.4.3 Potential drug-induced liver injury IMP discontinuation criteria 6.4",
"7 STUDY TREATMENT",
"7.1 Description of investigational medicinal product and",
"7.2 Treatment to b... |
NCT03695094 | 13 | ETHICS AND REGULATORY REQUIREMENTS ULA ATOR | 13 ETHICS AND REGULATORY REQUIREMENTS ULA ATOR | [] |
NCT03695094 | 13.1 | Informed consent | 13.1 Informed consent Study participant's informed consent must be obtained and documented in accordance with local regulations, ICH-GCP requirements, and the ethical principles that have their origin in the principles of the Declaration of Helsinki. any f Hel marketing nt must nts, an lsi Prior to obtaining informed c... | [] |
NCT03695094 | 13.2 | Study participant identification cards | 13.2 Study participant identification cards Upon signing the Informed Consent and Assent form (as applicable), the study participant or legal representative will be provided with a study participant identification card in the language of the study participant. The Investigator will fill in the study participant identif... | [] |
NCT03695094 | 13.3 | Independent Ethics Committees | 13.3 Independent Ethics Committees The study will be conducted under the auspices of an IEC, as defined in local regulations, ICH-GCP, and in accordance with the ethical principles that have their origin in the Declaration of Helsinki. hat c any extensions gulatio the The Investigator/UCB will ensure that an appropriat... | [] |
NCT03695094 | 13.4 | Study participant privacy | 13.4 Study participant privacy UCB staff (or designee) will affirm and uphold the study participant's confidentiality. Throughout this study, all data forwarded to UCB (or designee) will be identified only by the study participant number assigned at Screening. The Investigator agrees that representatives of UCB, its de... | [] |
NCT03695094 | 13.5 | Protocol amendments | 13.5 Protocol amendments Protocol changes may affect the legal and ethical status of the study and may also affect the statistical evaluations of sample size and the likelihood of the study fulfilling its primary objective. and any ay lling i y als Significant changes to the protocol will only be made as an amendment t... | [] |
NCT03695094 | 14 | FINANCE, INSURANCE, AND PUBLICATION COPY AND PUB | 14 FINANCE, INSURANCE, AND PUBLICATION COPY AND PUB Insurance coverage will be handled according to local requirements. ocal re Finance, insurance, and publication rights are addressed in the Investigator and/or CRO agreements, as applicable. REDACTEDg l ts a s authorizationPU addre | [] |
NCT03695094 | 15 | REFERENCES | 15 REFERENCES Andreasen AH, Brøsen K, Damkier P. A comparative pharmacokinetic study in healthy volunteers of the effect of carbamazepine and oxcarbazepine on CYP3A4. Epilepsia. 2007;48(3):490-6. anymamarketing er A azep Baker GA, Jacoby A, Buck D, Stalgis C, Monnet D. Quality of life of people with epilepsy: a Europea... | [] |
NCT03695094 | 16 | DECLARATION AND SIGNATURE OF INVESTIGATOR | 16 DECLARATION AND SIGNATURE OF INVESTIGATOR I confirm that I have carefully read and understood this protocol and agree to conduct this clinical study as outlined in this protocol, according to current Good Clinical Practice and local laws and requirements. I will ensure that all subInvestigators and other staff membe... | [] |
NCT03695094 | 17 | SPONSOR DECLARATION | 17 SPONSOR DECLARATION I confirm that I have carefully read and understand this protocol and agree to conduct this clinical study as outlined in this protocol and according to current Good Clinical Practice. This document cannot be used to support any marketing authorization application and any extensions or variations... | [
"Approval Signatures"
] |
NCT03717415 | 3 | Dose Expansion, All Cohorts | 3. Dose Expansion, All Cohorts
A. Cohort 1: Triple-negative Breast Cancer - i. Histologically confirmed metastatic triple-negative breast cancer based on the American Society of Clinical Oncology (ASCO)/CAP guidelines [\(1\)](#page-98-0). - ii. Received at least one prior line but no more than three prior lines of sys... | [
"A. Cohort 1: Triple-negative Breast Cancer",
"B. Cohort 2: Ovarian Cancer",
"C. Cohort 3: Mesothelioma",
"Study Drug, Formulation, Dose and Route of Administration:",
"Study Endpoints: Dose Escalation and Dose Expansion Endpoints:",
"Safety:",
"Pharmacokinetics:",
"Efficacy Endpoints:",
"Pharmacoge... |
NCT03717415 | 3 | STUDY DESIGN | 3 STUDY DESIGN | [] |
NCT03717415 | 3.1 | Overview of Study Design | 3.1 Overview of Study Design This is an open label Phase 1b/2 multicenter study in patients with advanced or metastatic solid tumors who have exhausted available, approved therapies and for which carboplatin is considered appropriate treatment. AEs will be assessed, and laboratory values, vital sign measurements, and e... | [] |
NCT03717415 | 3.1.1 | Dose Escalation | 3.1.1 Dose Escalation In the Dose Escalation phase, doses of rebastinib and carboplatin will be escalated using modified 3 + 3 dose escalation rules starting with rebastinib at 50 mg BID in combination with AUC5 of carboplatin. The next cohort is rebastinib at 100 mg BID with AUC5 of carboplatin. The third planned coho... | [] |
NCT03717415 | 3.1.2 | Dose Expansion | 3.1.2 Dose Expansion Upon determination of the MTD or an RP2D, the Dose Expansion phase will be initiated to enroll approximately 99 patients in three indication-specific cohorts. A Simon's two-stage design will be applied to the Dose Expansion phase to further evaluate the safety, tolerability, and preliminary efficac... | [] |
NCT03717415 | 3.2 | Number of Patients | 3.2 Number of Patients A total of approximately 117 patients (approximately 18 patients in the Dose Escalation phase and approximately 99 patients in the Dose Expansion phase) may be enrolled in this study. The study will be conducted at approximately 4 centers in the US during the Dose Escalation phase and up to 18 ce... | [] |
NCT03717415 | 3.3 | Duration of Study | 3.3 Duration of Study Patients will receive study treatment until they develop progressive disease, experience unacceptable toxicity, or withdraw consent. Patients will be eligible to receive study treatment as long as the Investigator and the Sponsor agree that the patient is showing clinical benefit and for as long a... | [] |
NCT03717415 | 4 | STUDY POPULATION | 4 STUDY POPULATION | [] |
NCT03717415 | 4.1 | Inclusion Criteria | 4.1 Inclusion Criteria Patients must meet all of the following criteria to be eligible to enroll in the study: - 1. Male or female patients ≥18 years of age at the time of informed consent. - 2. Dose Escalation - i. Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which carboplatin... | [] |
NCT03717415 | 4.2 | Exclusion Criteria | 4.2 Exclusion Criteria Patients meeting any of the following criteria will be excluded from the study: 1. Received prior anticancer or other investigational therapy within 28 days or 5× the half-life (whichever is shorter) prior to the first dose of study drug. See [Section](#page-63-0) [5.11.6](#page-63-0) for further... | [] |
NCT03717415 | 5 | STUDY DRUG ADMINISTRATION AND MANAGEMENT | 5 STUDY DRUG ADMINISTRATION AND MANAGEMENT Study drug will refer to rebastinib and carboplatin. In cases where there is a distinction in how they are to be administered, details for each will be specified. | [] |
NCT03717415 | 5.1 | Study Drug Description | 5.1 Study Drug Description Study drug will be labeled in accordance to applicable local and national regulations. It will be dispensed via the Interactive Response Technology (IRT). | [] |
NCT03717415 | 5.1.1 | Rebastinib | 5.1.1 Rebastinib Rebastinib will be provided by the Sponsor as tablets for oral administration containing 25 mg and 75 mg of active rebastinib. The tablets also contain microcrystalline cellulose, lactose, polyethylene glycol 3350, poloxamer 407, crospovidone, colloidal silicon dioxide, PRUV®, and butylated hydroxytolu... | [] |
NCT03717415 | 5.1.2 | Carboplatin | 5.1.2 Carboplatin Carboplatin will be provided by the Sponsor as a sterile, pyrogen-free, aqueous solution in its original form and packaging. Each mL contains 10 mg carboplatin and Water for Injection, USP. | [] |
NCT03717415 | 5.2 | Study Drug Dose and Administration | 5.2 Study Drug Dose and Administration | [] |
NCT03717415 | 5.2.1 | Rebastinib | 5.2.1 Rebastinib Rebastinib may be dispensed only under the supervision of the Investigator or an authorized designee and only for administration to study patients. Rebastinib will be dosed BID continuously throughout each cycle. In the Dose Escalation phase, rebastinib will be escalated from 50 mg to 100 mg in combina... | [] |
NCT03717415 | 5.2.2 | Carboplatin | 5.2.2 Carboplatin Carboplatin will be administered by IV infusion over approximately 60 minutes in accordance with institutional practices including premedication, if required, on Day 1 of each cycle and at least 21 days apart. A carboplatin dose will be calculated using the Calvert formula. The maximum carboplatin dos... | [] |
NCT03717415 | 5.3 | Dose Interruption/Modification and Management of Toxicities | 5.3 Dose Interruption/Modification and Management of Toxicities Study drugs may be interrupted or modified (i.e., dose reduced) at the discretion of the Investigator at any time due to AE, to accommodate palliative treatment, or for other reasons after consultation with the Sponsor. Dose reduction steps of rebastinib a... | [] |
NCT03717415 | 5.4 | Packaging and Labeling | 5.4 Packaging and Labeling Rebastinib will be supplied by the Sponsor as formulated drug in tablets for oral administration containing 25 mg and 75 mg of active rebastinib. The 75 mg tablets will be supplied in 30-count blister packs. The 25 mg tablets will be supplied in 28-count blister packs. Study drug labeling wil... | [] |
NCT03717415 | 5.5 | Storage Conditions | 5.5 Storage Conditions Instructions regarding the storage and handling will be on the label of the study drug as well as in the Pharmacy Manual. Rebastinib should be stored at controlled room temperature: 20°-25°C (68°-77°F). (Refer to United States Pharmacopeia [USP] Controlled Room Temperature.) The original packagin... | [] |
NCT03717415 | 5.6 | Study Drug Compliance | 5.6 Study Drug Compliance To ensure study drug compliance, the Investigator or designee must supervise all study drug dosing that occurs at the site. At each visit, site personnel must review that the patient is compliant with at-home study drug dosing and remind the patient of study drug dosing requirements. Complianc... | [] |
NCT03717415 | 5.7 | Study Drug Accountability | 5.7 Study Drug Accountability Accountability for the study drug at the study site is the responsibility of the Investigator. The Investigator must ensure that the study drug is used only in accordance with this protocol. Where allowed, the Investigator may choose to assign drug accountability responsibilities to a phar... | [] |
NCT03717415 | 5.8 | Disposal, Return, or Retention of Unused Study Drug | 5.8 Disposal, Return, or Retention of Unused Study Drug Patients must be instructed to return all used, partially used, and full rebastinib blister packs. The site staff or pharmacy personnel (as appropriate) must retain all rebastinib materials returned by the patients and carboplatin materials until returned to Spons... | [] |
NCT03717415 | 5.9 | Method of Assigning Patients to Treatment | 5.9 Method of Assigning Patients to Treatment In the Dose Escalation phase, patients will be assigned to the dose of rebastinib according to the cohort in which they are enrolled. In the Dose Expansion phase, patients will be assigned to an RP2D of rebastinib and enrolled into the appropriate indication-specific cohort... | [] |
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