protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02293837 | 9 | STATISTICAL CONSIDERATIONS AND ANALYTICAL PLAN | 9. STATISTICAL CONSIDERATIONS AND ANALYTICAL PLAN | [] |
NCT02293837 | 9.1 | ANALYSIS SAMPLES | 9.1 ANALYSIS SAMPLES Modified Intent to Treat (mITT) sample will include all randomized participants who received any dose of study treatment. The efficacy analyses will be based on the mITT sample according to the group to which the participants are assigned. Per protocol samples will be assessed for week 52 (PP1) and... | [] |
NCT02293837 | 9.2 | ANALYSIS OF ENDPOINTS | 9.2 ANALYSIS OF ENDPOINTS Because the natural history of disease in T1DM is considerably different in children as compared with adults, with adults having a much more indolent disease course, the primary analysis of the primary endpoint will be evaluated using the pediatric participants in the mITT sample. Primary anal... | [] |
NCT02293837 | 9.2.1 | Primary Endpoint | 9.2.1 Primary Endpoint The primary analysis of the primary endpoint, change in MMTT-stimulated mean 2 hour C-peptide AUC at week 52, will test the null hypothesis of "no treatment group difference" versus the two-sided alternative using pediatric participants from the mITT sample. The hypothesis test and baseline-adjus... | [] |
NCT02293837 | 9.2.2 | Secondary Endpoints | 9.2.2 Secondary Endpoints The null hypothesis proposes that there is no difference in the secondary endpoint (measured either as means or proportions) between study groups. The alternative hypothesis proposes the opposite; that there is a difference in the secondary endpoints between the treatment and control groups. A... | [] |
NCT02293837 | 9.2.3 | Safety Analysis | 9.2.3 Safety Analysis Reports summarizing safety data will be prepared at the end of the study and periodically throughout the study for regulatory filings, the DSMB, and for the medical monitor and study management team. Safety reports will be prepared to meet the needs of those groups and individuals responsible for ... | [] |
NCT02293837 | 9.2.4 | Medical History | 9.2.4 Medical History Medical history within the past 12 months—including the existence of current signs and symptoms—will be collected for each body system. | [] |
NCT02293837 | 9.2.5 | Use of Medications | 9.2.5 Use of Medications All medications taken by or administered to study participants beginning 30 days before enrollment and continuing throughout the study will be collected. All medications used will be coded according to the World Health Organization (WHO) drug dictionary. The number and percentage of participant... | [] |
NCT02293837 | 9.3 | INTERIM ANALYSES AND DATA REVIEW | 9.3 INTERIM ANALYSES AND DATA REVIEW Per the protocol, an interim report of safety and metabolic data from adult participants was reviewed by the DSMB and FDA. At least 30 adult subjects had week 12 Cpeptide data available for the report. Prior to initiating the study in the pediatric age group (6-17 years old), adults... | [] |
NCT02293837 | 9.4 | SAMPLE SIZE | 9.4 SAMPLE SIZE The primary analysis of the primary endpoint will be conducted using data from the 78 pediatric participants. This target number was selected with the goal of detecting a clinically meaningful improvement of 39% for tocilizumab over placebo. Power estimates associated with these targets are discussed be... | [] |
NCT02293837 | 9.5 | PHARMACOKINETIC ANALYSES | 9.5 PHARMACOKINETIC ANALYSES All PK analyses will use the actual sampling times. PK parameters Cmax (µg/mL), tmax (h), Cmin (µg/mL), AUC 0–28 d (µgh/mL) (following the first and last infusions), and AUC 0-t or AUC 0-∞, will be estimated, as data permit. In addition, terminal phase half-life (t1/2,z) and clearance (CL) ... | [] |
NCT02293837 | 9.6 | REPORTING DEVIATIONS FROM THE ORIGINAL STATISTICAL PLAN | 9.6 REPORTING DEVIATIONS FROM THE ORIGINAL STATISTICAL PLAN The principal features of both the study design and the plan for statistical data analysis are outlined in this protocol and in the statistical analysis plan (SAP). Any change in these features requires either a protocol or an SAP amendment, which is subject t... | [] |
NCT02293837 | 10 | STUDY ADMINISTRATION | 10 STUDY ADMINISTRATION | [] |
NCT02293837 | 10.1 | SPONSOR | 10.1 SPONSOR This clinical trial is conducted through the NIAID NIH-funded Cooperative Agreement awarded to the Benaroya Research Institute at Virginia Mason (Seattle, WA) (BRI) to support the Immune Tolerance Network (ITN), a collaborative network for clinical research. The ITN provides financial support for the condu... | [] |
NCT02293837 | 10.2 | RELATIONSHIP WITH INDUSTRY | 10.2 RELATIONSHIP WITH INDUSTRY Tocilizumab provided by the drug manufacturer (Genentech, Inc. a member of the Roche group, South San Francisco, CA) free of charge will be used in the United States for treatment of adult and pediatric participants, and Genentech, Inc. will also be providing additional financial support... | [] |
NCT02293837 | 11 | ACCESS TO SOURCE DATA/DOCUMENTS | 11 ACCESS TO SOURCE DATA/DOCUMENTS The investigational sites participating in this study will maintain the highest degree of confidentiality permitted for the clinical and research information obtained from participants in this clinical trial. Medical and research records should be maintained at each site in the strict... | [] |
NCT02293837 | 12 | QUALITY CONTROL AND QUALITY ASSURANCE | 12 QUALITY CONTROL AND QUALITY ASSURANCE The investigator is required to keep accurate records to ensure that the conduct of the study is fully documented. The investigator is required to ensure that all CRFs are completed for every participant entered in the trial. The Global Study Sponsor (DAIT, NIAID, NIH) is respon... | [] |
NCT02293837 | 13 | ETHICAL CONSIDERATIONS AND COMPLIANCE WITH GOOD CLINICAL PRACTICE | 13 ETHICAL CONSIDERATIONS AND COMPLIANCE WITH GOOD CLINICAL PRACTICE | [] |
NCT02293837 | 13.1 | STATEMENT OF COMPLIANCE | 13.1 STATEMENT OF COMPLIANCE This trial will be conducted in compliance with the protocol, current Good Clinical Practice (GCP) guidelines—adopting the principles of the Declaration of Helsinki and all applicable regulatory requirements. Prior to study initiation, the protocol and the informed consent documents will be... | [] |
NCT02293837 | 13.2 | INFORMED CONSENT | 13.2 INFORMED CONSENT The informed consent form is a means of providing information about the trial to a prospective participant and allows for an informed decision about participation in the study. All participants (or their legally acceptable representative) must read, sign, and date a consent form before participati... | [] |
NCT02293837 | 13.3 | PRIVACY AND CONFIDENTIALITY | 13.3 PRIVACY AND CONFIDENTIALITY A participant's privacy and confidentiality will be respected throughout the study. Each participant will be assigned a sequential identification number. This number, rather than the participant's name, will be used to collect, store, and report participant information. | [] |
NCT02293837 | 14 | PUBLICATION POLICY | 14 PUBLICATION POLICY The ITN policy on publication of study results will apply to this study. Authorized participants may find details regarding the policy statement on the ITN internet website As a jointly sponsored study with Type I Diabetes TrialNet, publications will also comply with TrialNet publications policy a... | [] |
NCT02293837 | 15 | REFERENCES | 15 REFERENCES - 1. Type 1 Diabetes, 2010; Prime Group for JDRF, Mar 2011. 2010. - 2. Shrestha SS, Zhang P, Albright A, Imperatore G. Medical expenditures associated with diabetes among privately insured U.S. youth in 2007. Diabetes Care. 2011;34(5):1097-1101. - 3. Gregg EW, Li Y, Wang J, et al. Changes in diabetes-rela... | [
"APPENDIX 1. SCHEDULE OF EVENTS1"
] |
NCT02392507 | 1 | Protocol I4X-MC-JFCP(b) | 1. Protocol I4X-MC-JFCP(b) A Single-Arm, Multicenter, Open-Label, Phase 2 Study of nab® -Paclitaxel (Abraxane® ) and Carboplatin Chemotherapy plus Necitumumab (LY3012211) in the First-Line Treatment of Patients with Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) EudraCT Number: 2016-002071-96
Confidential Inform... | [
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NCT02392507 | 2 | Synopsis | 2. Synopsis
Study Rationale Necitumumab (LY3012211; IMC-11F8; Portrazza® ) is a recombinant human monoclonal antibody (mAb) of the immunoglobulin G, subclass 1, that blocks the ligand binding site of the epidermal growth factor receptor (EGFR). The EGFR is a member of the human EGFR family of tyrosine kinases. Epiderm... | [
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NCT02392507 | 3 | Table of Contents | 3. Table of Contents A Single-Arm, Multicenter, Open-Label, Phase 2 Study of nab® -Paclitaxel (Abraxane® ) and Carboplatin Chemotherapy plus Necitumumab (LY3012211) in the First-Line Treatment of Patients with Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) | Section | | Page | |-----------------------------------... | [
"List of Tables",
"List of Figures",
"List of Attachments"
] |
NCT02392507 | 4 | Abbreviations and Definitions | 4. Abbreviations and Definitions | Term | Definition | | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT02392507 | A | Single Arm, Multicenter, Open-Label, Phase 2 Study of nab® -Paclitaxel (Abraxane® ) and Carboplatin Chemotherapy plus Necitumumab (LY3012211) in the First-Line Treatment of Patients with Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) | A Single Arm, Multicenter, Open-Label, Phase 2 Study of nab® -Paclitaxel (Abraxane® ) and Carboplatin Chemotherapy plus Necitumumab (LY3012211) in the First-Line Treatment of Patients with Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
5. Introduction Necitumumab (LY3012211; IMC-11F8) is a recombinant human mono... | [
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NCT02432846 | 1 | SYNOPSIS | 1 SYNOPSIS | Name of the Sponsor/Company: | Study Code: | |--------------------------------------------|---------------------| | Immunicum AB (publ) | IM-201 | | Name of Investigational Medicinal Product: | EudraCT No.: | | Intuvax | 2014-004510-28 | | Development Phase of the Study: | Trial under an IND: | | Phase II ... | [
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NCT02432846 | 2 | TABLE OF CONTENTS | 2 TABLE OF CONTENTS | Section | | | | Page | |---------|------------|---------------------------|--------------------------------------------------------------------|----------| | 1 | | | SYNOPSIS 2 | | | 2 | | | TABLE OF CONTENTS 8 | | | 3 | | | LIST OF ABBREVIATIONS AND DEFINITION OF TERMS | 12 | | | 3.1 | | List of ... | [] |
NCT02432846 | 3 | LIST OF ABBREVIATIONS AND DEFINITION OF TERMS | 3 LIST OF ABBREVIATIONS AND DEFINITION OF TERMS | [] |
NCT02432846 | 3.1 | List of Abbreviations | 3.1 List of Abbreviations AB plasma Plasma from blood with blood-group AB AE Adverse Event ALAT Alanine Aminotransferase ALP Alkaline Phosphatase APTT Activated Partial Thromboplastin Time ASA Acetylsalicylic Acid ASAT Aspartate Aminotransferase BP Blood Pressure CA Competent Authority Ca Calcium CD Cluster of designat... | [] |
NCT02432846 | 3.2 | Definition of Terms | 3.2 Definition of Terms NB: Detailed definitions of terms from the updated guideline Response Evaluation Criteria In Solid Tumors (RECIST v1.1) [1] are included in Section 10.2.2.2 and detailed definitions for Dose Limiting Toxicity (DLT) based on Common Terminology Criteria for Adverse Events (CTCAE) grading [2] for s... | [] |
NCT02432846 | 5.1 | Background | 5.1 Background Renal cell carcinoma (RCC) is the most common form of kidney cancer and comprises 3% of all malignant tumors in adults [6]. Interleukin-2 (IL-2) was introduced as therapy for metastatic RCC (mRCC) over 20 years ago and systemic IL-2 or interferon-a (IFN-a) has remained the standard of care for patients w... | [] |
NCT02432846 | 5.2 | Study Rationale | 5.2 Study Rationale No curative treatment exists for mRCC, except in very few cases where a single metastasis can be surgically removed. General chemotherapy does not lead to remission and is therefore not used as regular treatment. Improved understanding of the underlying cellular mechanisms of the RCC pathogenesis ha... | [] |
NCT02432846 | 5.3 | Potential Risks and Benefits | 5.3 Potential Risks and Benefits   
Clinical Risk/Benefit Assessment Treatment with Intuvaximmunotherapy might potentially result in prolonged survival. The risk of serious immunologic reactions is expected to be low considering data from the suppo... | [
"Clinical Risk/Benefit Assessment"
] |
NCT02432846 | 6 | STUDY OBJECTIVES | 6 STUDY OBJECTIVES | [] |
NCT02432846 | 6.1 | Primary Objectives | 6.1 Primary Objectives The primary objectives are: - To evaluate median OS from randomization in mRCC patients overall and by subgroup, i.e. in high-risk and in intermediate-risk patients separately, receiving two (2) vaccine doses of Intuvax pre-nephrectomy, followed by sunitinib initiated five (5) to eight (8) weeks ... | [] |
NCT02432846 | 6.2 | Secondary Objectives | 6.2 Secondary Objectives The secondary objectives are: - To evaluate safety and tolerability in high- and intermediate-risk mRCC patients receiving two (2) vaccine doses of Intuvax pre-nephrectomy followed by sunitinib post-nephrectomy and in non-vaccinated patients receiving sunitinib post-nephrectomy - To evaluate PF... | [] |
NCT02432846 | 7 | INVESTIGATIONAL PLAN | 7 INVESTIGATIONAL PLAN | [] |
NCT02432846 | 7.1 | Study Design and Plan-Description | 7.1 Study Design and Plan-Description The study is an open-label, randomized, controlled, two (2) armed, multicenter, phase II study. Intermediate- and high-risk mRCC patients according to Heng criteria are eligible for participation [4]. Stratified randomization based on Heng-risk categories applies. The patients are ... | [] |
NCT02432846 | 7.2 | Study Procedures | 7.2 Study Procedures | [] |
NCT02432846 | 7.21 | Schedule of Study Events | 7.21 Schedule of Study Events The study assessments described in the sections below are presented in detail in Section 10.2 (Efficacy assessments), Section 10.4 (Demographic data and baseline characteristics) and Section 10.5 (Safety assessments). Recording and reporting of AEs are described in detail in Section 11 (Ad... | [] |
NCT02432846 | 7.21.1 | Screening Visit | 7.21.1 Screening Visit This visit is applicable for all patients. ACTIVITIES AND ASSESSMENTS!: - e Informed Consent, Section 13.1.3 - e Demography, Section 10.4.1 - e Medical and Surgical history, Section 10.4.2 - e CT Scan to be done within 3 weeks from Screening Visit unless a CT scan has been performed in clinical r... | [] |
NCT02432846 | 7.2.1.2 | Vacc1 Visit (if applicable) | 7.2.1.2 Vacc1 Visit (if applicable) This visit is applicable only for patients randomized to Intuvax followed by sunitinib. TIME WINDOW: Vacc1 Visit to be done within 28 days after Screening ACTIVITIES AND ASSESSMENTS: Day before vaccination (optional): The following assessments may be done the day before vaccination f... | [
"Day of vaccination (Pre-Vaccination):",
"Day of vaccination (Vaccination)",
"Day of vaccination (Post-Vaccination)"
] |
NCT02432846 | 7.2.1.3 | Vacc2 Visit (If applicable) | 7.2.1.3 Vacc2 Visit (If applicable) This visit is applicable only for patients randomized to Intuvax followed by sunitinib. TIME WINDOW: 14 days (±3 days) after Vacc1 Visit ACTIVITIES AND ASSESSMENTS Exactly the same activities and assessments will be done at this visit as was done on Vacc1 Visit except for auto- and a... | [] |
NCT02432846 | 7.2.1.4 | Nephrectomy Visit | 7.2.1.4 Nephrectomy Visit This visit is applicable for all patients. TIME WINDOWS: At least 3 days after Vacc2 Visit and within 63 days from Screening Visit for patients randomized to Intuvax followed by sunitinib. Within 63 days from Screening Visit for patients randomized to sunitinib only. ACTIVITIES AND ASSESSMENTS... | [
"Prior to Nephrectomy (may be done the day before vaccination for logistical reasons)",
"Nephrectomy and post Nephrectomy assessments"
] |
NCT02432846 | 7.2.1.5 | Sun-Start Visit | 7.2.1.5 Sun-Start Visit This visit is applicable for all patients. TIME WINDOW: Five (5) to eight (8) weeks after Nephrectomy Visit NB: The CT scan does not have to be done the very same day as the study visit. However, it has to be done within the above specified time window. The laboratory safety blood and urine asse... | [
"ACTIVITIES AND ASSESSMENTS:"
] |
NCT02432846 | 7.2.1.6 | SFU[6W], SFU[12W], SFU[24W], SFU[36W], SFU[48W], and SFU[60W] | 7.2.1.6 SFU[6W], SFU[12W], SFU[24W], SFU[36W], SFU[48W], and SFU[60W] These visits are applicable for all patients unless locally CT-verified PD occurs. In case of PD this visit should be considered the End-of-Study Visit. If SFU[60W] is scheduled ≥76 weeks since Screening this visit should be considered the End-of-Stu... | [
"TIME WINDOWS:",
"ACTIVITIES AND ASSESSMENTS:"
] |
NCT02432846 | 7.2.1.7 | End of Study Visit | 7.2.1.7 End of Study Visit This visit is applicable for all patients. TIME WINDOW: 78 ±2 weeks after Screening NB: The CT/MRI scan does not have to be done the very same day as the study visit. However, it has to be done within the above specified time window.
ACTIVITIES AND ASSESSMENTS: The same activities and assess... | [
"ACTIVITIES AND ASSESSMENTS:"
] |
NCT02432846 | 7.2.1.8 | Safety Evaluation 30 Days after Last Dose of Investigational Medicinal Product | 7.2.1.8 Safety Evaluation 30 Days after Last Dose of Investigational Medicinal Product The safety evaluation, i.e. collection of SAEs, as described in Section 11.2 is applicable for all patients who have received any IMP. ACTIVITIES AND ASSESSMENTS: • SAEs, Section 11.2 | [] |
NCT02432846 | 7.2.1.9 | Extra Visits | 7.2.1.9 Extra Visits Extra Visits are applicable for all patients if any symptoms need follow-up between planned visits.
TIMING: The patient will be scheduled for a visit as soon as possible.
ACTIVITIES AND ASSESSMENTS: - Concomitant Medication, Section 10.4.4 - Physical Examination, Section 10.5.3 - Vital Signs, Sec... | [
"TIMING:",
"ACTIVITIES AND ASSESSMENTS:"
] |
NCT02432846 | 7.2.1.10 | Post-Study Survival Information | 7.2.1.10 Post-Study Survival Information This measure is applicable for all patients. • Survival data, Section 11.3 Confidential Page 33 of 87 Clinical Study Protocol Sponsor: Immunicum AB (publ) Date: 12 February 2019 EudraCT No.: 2014-004510-28 | [] |
NCT02432846 | 7.2.2 | Study Flow Charts | 7.2.2 Study Flow Charts Detailed instructions on vital signs, AE collection, and blood sampling in connection to vaccination are shown in Table 3.
Table 2 Study Flow Chart | Visit | ScreeningDay 1 | Vacc1Intuvax +sunitinib:Day 2-28sunitinibonly:N/A | Vacc2Intuvax +sunitinib:Day 16-42sunitinibonly:N/A | NephrectomyIntu... | [
"Table 2 Study Flow Chart",
"Cont. Table 2 Study Flow Chart"
] |
NCT02432846 | 7.3 | Discussion of Study Design, Including the Choice of Control Groups | 7.3 Discussion of Study Design, Including the Choice of Control Groups Intuvax is developed as an immune primer for cancer treatment that preferably should be combined with a drug that acts in synergy with Intuvax by inhibiting tumor-induced immunosuppression. In this study, Intuvax is given in combination with sunitin... | [] |
NCT02432846 | 7.4 | Study Period | 7.4 Study Period Expected timelines in the study: Start of inclusion: Q2 2015 Planned last patient last study visit or last patient's safety evaluation (up to 30 days after the last patient's last dose of an IMP), whichever occurs later: Q3 2019 | [] |
NCT02432846 | 7.5 | End of Study | 7.5 End of Study The end of study is defined as the last patient last visit (LPLV) or the last patient's safety evaluation (up to 30 days after the last patient's last dose of an IMP), whichever occurs later. Confidential Page 38 of 87 Clinical Study Protocol Sponsor: Immunicum AB (publ) Date: 12 February 2019 EudraCT ... | [] |
NCT02432846 | 8 | SELECTION OF STUDY POPULATION | 8 SELECTION OF STUDY POPULATION | [] |
NCT02432846 | 8.1 | Number of Patients | 8.1 Number of Patients The estimated number of patients to be randomized in the study is around 90. The patients will be randomized in a 2:1 (vaccination:control) ratio. Stratification will be done at randomization for intermediate- and high-risk patients, Section 3.2, and Section 9.2. The choice of sample size is disc... | [] |
NCT02432846 | 8.2 | Inclusion Criteria | 8.2 Inclusion Criteria The patients have to meet all of the following criteria to be eligible to enter the study: - 1) Newly (<6 months) diagnosed RCC (histological/cytological verification is optional) with at least one (1) CT-verified metastasis ≥10 mm for which complete metastasectomy is not planned. US patients mus... | [] |
NCT02432846 | 8.3 | Exclusion Criteria | 8.3 Exclusion Criteria Patients meeting any of the following criteria will not be permitted to enter the study: 1) Life expectancy less than 4 months - 2) CNS metastasis that is symptomatic or progressing or untreated or that required current therapy (e.g. evidence of new or enlarging CNS metastasis or new neurological... | [] |
NCT02432846 | 8.4 | Restrictions | 8.4 Restrictions Intuvax: Treatment requires absolute fasting for a period of 4 hours prior to vaccination. Sunitinib: Restrictions for treatment as in the SmPC/USPI for Sutent® (sunitinib), e.g. avoid concomitant administration of potent CYP3A4 inducers or inhibitors. Nephrectomy: Same restrictions apply as in clinica... | [] |
NCT02432846 | 8.5 | Removal of Patients from Therapy or Assessment | 8.5 Removal of Patients from Therapy or Assessment Patients are free to discontinue their participation in the study at any time. Withdrawal from the study will not affect or prejudice the patient's further care or treatment. Patients may be withdrawn from study treatment and assessments at any time, if deemed necessar... | [] |
NCT02432846 | 8.6 | Premature Termination of the Study | 8.6 Premature Termination of the Study The Investigator or the Sponsor may terminate this study prematurely for any reasonable cause. The Institutional Review Board(s) (IRBs)/Independent Ethics Committee(s) (IECs) and Competent Authorities (CAs) should be informed promptly. Conditions that may warrant termination inclu... | [] |
NCT02432846 | 8.7 | Study Stopping Criteria | 8.7 Study Stopping Criteria Study stopping criteria are defined as: - Any death within 30 days of Intuvax administration that is not clearly attributable to surgery or disease progression - Any CTCAE grade 4 autoimmune disorder - Any toxicity that is unexpected, significant or unacceptable risk to the patients enrolled... | [] |
NCT02432846 | 9.1 | Investigational Medicinal Products | 9.1 Investigational Medicinal Products | [] |
NCT02432846 | 9.1.1 | Treatment Regimens | 9.1.1 Treatment Regimens Patients will be randomized to one (1) of the following two (2) treatment regimens: - (i) Two (2) doses of Intuvax (10x108 DCs) administered intratumorally into the primary tumor 14 +3 days apart followed by nephrectomy and sunitinib initiated five (5) to eight (8) weeks after nephrectomy for a... | [] |
NCT02432846 | 9.1.2 | Identity of Investigational Medicinal Products | 9.1.2 Identity of Investigational Medicinal Products
Intuvax The Intuvax administered is a cryopreserved dendritic cell suspension containing 11.7x10° viable and HLA class Il expressing cells in 1 mL heat-inactivated AB plasma, supplemented with 10% dimethyl sulfoxide (DMSO). One (1) mL Intuvax is filled in vials whic... | [
"Intuvax",
"Sunitinib"
] |
NCT02432846 | 9.1.3 | Packaging and Labelling of Investigational Medicinal Products | 9.1.3 Packaging and Labelling of Investigational Medicinal Products All manufacturing is performed in accordance with current Good Manufacturing Practice (cGMP) and with approved license for production of cell-based advanced therapeutic medicine products. Version: Final 9.0 Study Code: IM-201 Date: 12 February 2019 Eud... | [] |
NCT02432846 | 9.1.4 | Storage, Handling and Dispensing of Investigational Medicinal Products | 9.1.4 Storage, Handling and Dispensing of Investigational Medicinal Products
Intuvax Intuvax is transported and stored at -150 °C or below in a low temperature freezer or in liquid A study specific manual describing all details regarding handling, transport and preparation of the IMP will be available prior to study s... | [
"Intuvax",
"Sunitinil",
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NCT02432846 | 9.2 | Method of Assigning Patients to Treatment Groups | 9.2 Method of Assigning Patients to Treatment Groups At Screening the patient will be assigned a site specific screening number. This number will be generated automatically by Trial-on-Line, the electronic data capture (EDC) system used in the study. The screening number will be in the following format XX-YYYY. The let... | [] |
NCT02432846 | 9.3 | Selection of Doses in the Study | 9.3 Selection of Doses in the Study
Intuvax The Intuvax dose to be administered in this study consists of 10 x106 viable and HLA class II expressing DCs. The outcome of Immunicum AB's first-in-man study of Intuvax in RCC Confidential Page 46 of 87 patients (Protocol No.: IM-101 and EudraCT No.: 2011-002039-25) in whic... | [
"Intuvax",
"Sunitinib",
"Duration of treatment",
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"Sunitinib",
"Active control, dosage and mode of administration"
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NCT02432846 | 9.4 | Selection and Timing of Dose for Each Patient | 9.4 Selection and Timing of Dose for Each Patient The patients will be randomized to treatment when the results from all assessments made at Screening are available. No time window between dosing of different patients applies in this study. The time window between Intuvax doses for the individual patient is 14 ±3 days.... | [] |
NCT02432846 | 9.5 | Blinding | 9.5 Blinding This is an open label study. | [] |
NCT02432846 | 9.6 | Prior and Concomitant Therapy | 9.6 Prior and Concomitant Therapy The following medications/therapies are prohibited during the study and within 28 days prior to Screening: - Other investigational products - Other systemic antitumor therapy. - Local radiation therapy to any area except for the abdominal/retropertioneal area including the kidney tumor... | [] |
NCT02432846 | 9.7 | Treatment Compliance | 9.7 Treatment Compliance
Intuvax Administration will be done at the clinic by trained study personnel. Treatment compliance will be accomplished by documenting in record (i.e. the drug accountability, preparation, administration logs, the patients' eCRF and medical records) information on, but not limited to: the batc... | [
"Intuvax",
"Sunitinib"
] |
NCT02432846 | 9.8 | Drug Accountability | 9.8 Drug Accountability Intuvax and sunitinib accountability, i.e. documentation of deliveries and return between the manufacturer, storage center, pharmacy, and/or the clinic shall be maintained. It is the responsibility of the Investigator or trained designee to determine Intuvax and sunitinib accountability and comp... | [] |
NCT02432846 | 9.9 | Post Study Treatment | 9.9 Post Study Treatment Intuvax is an IMP under development and will consequently not be available for treatment of the patients after study completion. Immunicum AB will pay the patients' sunitinib treatment during their participation in the study except for US patients who have health insurance that covers these cos... | [
"Primary endpoints",
"Secondary endpoints"
] |
NCT02432846 | 10.2 | Efficacy Assessments | 10.2 Efficacy Assessments | [] |
NCT02432846 | 10.2.1 | Primary Efficacy Variables and Assessments | 10.2.1 Primary Efficacy Variables and Assessments | [] |
NCT02432846 | 10.2.1.1 | Overall Survival (OS) | 10.2.1.1 Overall Survival (OS) 0OS is defined as time from randomization to death from any cause. The OS reported from patients according to Heng criteria in the two (2) different treatment arms is a primary efficacy variable. | [] |
NCT02432846 | 10.2.1.2 | Eighteen-(18)-Month Survival Rate | 10.2.1.2 Eighteen-(18)-Month Survival Rate 18-month survival rate is defined as the proportion of patients alive 18 months after randomization. | [] |
NCT02432846 | 10.2.2 | Secondary Efficacy Variables and Assessments | 10.2.2 Secondary Efficacy Variables and Assessments | [] |
NCT02432846 | 10.2.2.1 | Progression Free Survival (PFS) from Start of Sunitinib | 10.2.2.1 Progression Free Survival (PFS) from Start of Sunitinib PFS from start of sunitinib is defined as time from Sunitinib Start Visit to PD or death following sunitinib initiation from any cause, whichever occurred first. PFS from start of sunitinib will be evaluated per stratum and in total from the two (2) diffe... | [] |
NCT02432846 | 10.2.2.2 | Objective Response Rate and Duration of Response and Stable Disease from Start of Sunitinib | 10.2.2.2 Objective Response Rate and Duration of Response and Stable Disease from Start of Sunitinib Evaluation of tumor response is based on centrally assessed CT scans, Section 10.4.3, according to the RECIST 1.1 guideline [1].
Definitions - RECIST v1.1
a) Measurable Disease The presence of at least one (1) measura... | [
"Definitions - RECIST v1.1",
"a) Measurable Disease",
"« Malignant lymph nodes",
"b) Response Criteria",
"Evaluation of Best Overall Response",
"Definitions for Response Evaluation",
"a) Confirmation of Response",
"b) Response rate",
"c) Objective response",
"d) Disease control rate (DCR)",
"e) ... |
NCT02432846 | 10.2.2.3 | Time to Progression (TTP) from Start of Sunitinib | 10.2.2.3 Time to Progression (TTP) from Start of Sunitinib TTP defined as time from Sunitinib Start Visit to date of first observed progression or date of death if the death was due to disease progression (whichever came first). Progressive disease is defined by RECIST v1.1 criteria and by clinical evaluation. Note: Fo... | [] |
NCT02432846 | 10.2.2.4 | Number of Infiltrating CD8+ T-Cells | 10.2.2.4 Number of Infiltrating CD8+ T-Cells At Nephrectomy two (2) separate biopsies from viable tumor tissue (10x10x5 mm) will be collected at least one (1) cm from each other from the resected renal tumor will be sent to , where they will be assessed centrally. The samples will be al Wi e patient's unique screening ... | [] |
NCT02432846 | 10.3 | Drug Concentration Assessments - N/A | 10.3 Drug Concentration Assessments - N/A | [] |
NCT02432846 | 10.4 | Demographic and Other Baseline Characteristics | 10.4 Demographic and Other Baseline Characteristics | [] |
NCT02432846 | 10.4.1 | Demographic and Baseline Data | 10.4.1 Demographic and Baseline Data The following demographic and baseline data will be collected at the Screening Visit: - « Date of birth - e Sex - e Race (White, Asian, Black, American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander) Clinical Study Protocol Sponsor: Immunicum AB (publ) Date: 12 F... | [] |
NCT02432846 | 10.4.2 | Medical and Surgical History | 10.4.2 Medical and Surgical History MEDICAL AND SURGICAL HISTORY (EXCLUDING MRCC) Clinical relevant past and present medical and surgical diagnoses non-related to RCC will be recorded at Screening in the eCRF. Medical History will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 17.1. ME... | [] |
NCT02432846 | 10.4.3 | Efficacy Assessments by Imaging | 10.4.3 Efficacy Assessments by Imaging The locally assessed CT scan in conjunction with screening is to verify patient eligibility. This scan will be performed within 3 weeks before the Screening Visit unless a CT scan has been done in clinical routine within 6 weeks prior to the Screening Visit. Brain imaging: every s... | [] |
NCT02432846 | 10.4.4 | Prior and Concomitant Medication/Therapy | 10.4.4 Prior and Concomitant Medication/Therapy Prior medication/therapy is defined as medication/therapy administered prior to Screening Visit. All medication/therapy administered after Screening Visit are considered concomitant medication/therapy. Prior medication/therapy will be indicated as past or ongoing at Scree... | [] |
NCT02432846 | 10.4.5 | Electrocardiogram (ECG) | 10.4.5 Electrocardiogram (ECG) A standard 12-lead electrocardiogram (ECG) recording will be performed according to local practice at Screening for identification of any heart failure. An overall interpretation of the ECG as "Normal" or "Abnormal" will be done. If an abnormal finding is considered clinical significant t... | [] |
NCT02432846 | 10.4.6 | Serology | 10.4.6 Serology Blood samples for HIV, HBV and HCV will be collected and analyzed at Screening. Presence of any of these infections is an exclusion criterion. Confidential Page 59 of 87 Date: 12 February 2019 EudraCT No.: 2014-004510-28 Clinical Study Protocol Sponsor: Immunicum AB (publ) Version: Final 9.0 Study Code:... | [] |
NCT02432846 | 10.4.7 | Human Leukocyte Antigen (HLA)-typing | 10.4.7 Human Leukocyte Antigen (HLA)-typing . patient's unique screening number. Blood samples will be taken at Screening for evaluating the patient's HLA type. HLA-A, HLA-B and HLA-DRB1 will be analyzed centrally by high resolution tissue typing assays at The blood samples collected should be labelled with the patient... | [] |
NCT02432846 | 10.5 | Safety Assessments | 10.5 Safety Assessments | [] |
NCT02432846 | 10.5.1 | Safety Variables | 10.5.1 Safety Variables The following safety variables will be measured: - AEs - Physical Examination - Vital Signs - Laboratory Safety Assessments blood (hematology, clinical chemistry, and coagulation) and urine including pregnancy - Other Safety Measurements (auto- and alloimmunization) | [] |
NCT02432846 | 10.5.2 | Adverse Events | 10.5.2 Adverse Events AEs will be recorded during the study period from Screening Visit to the completion of the End-of-Study Visit. SAEs will be recorded during the study period from Screening Visit to the completion of the End-of-Study Visit or up to 30 days after last dose of IMP administered in the study, whichever... | [] |
NCT02432846 | 10.5.3 | Physical Examination | 10.5.3 Physical Examination The timings of physical examinations are described in Section 7.2.1 and Table 2. A physical examination in accordance with this protocol includes: Skin, eye, ear, nose and throat, respiratory, cardiovascular, abdomen, lymphatic, and neurological/musculoskeletal (including reflexes) The outco... | [] |
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