protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03717415 | 5.10 | Blinding | 5.10 Blinding This is an open-label study. | [] |
NCT03717415 | 5.11 | Prior and Concomitant Treatment and Procedures | 5.11 Prior and Concomitant Treatment and Procedures | [] |
NCT03717415 | 5.11.1 | Prior Medications and Procedures | 5.11.1 Prior Medications and Procedures Information regarding any medication including vitamin supplements, over-the-counter medications and oral herbal preparations or non-drug therapy or procedure taken or performed within 30 days prior to screening and before the first dose of study drug must be documented in the pa... | [] |
NCT03717415 | 5.11.2 | Prior Anticancer Medications and Procedures | 5.11.2 Prior Anticancer Medications and Procedures Any prior anticancer medication or procedure must be documented in the patient's source documents and the eCRF. | [] |
NCT03717415 | 5.11.3 | Concomitant Medications | 5.11.3 Concomitant Medications All medications, including vitamin supplements, over-the-counter medications, and oral herbal preparations; non-drug therapies taken on or after the first day of study drug dose through and including Follow Up Safety Visit (FSV) or initiation of new anticancer therapy after the last dose ... | [] |
NCT03717415 | 5.11.4 | Permitted Medication | 5.11.4 Permitted Medication Medications that are required to manage AEs and control cancer symptoms are allowed based on standard clinical practice, unless specifically excluded. Supportive care agents are permitted as needed per ASCO guidelines [\(1\)](#page-98-0) or local institutional practices. However, supportive ... | [] |
NCT03717415 | 5.11.5 | Medications to Avoid or Take with Caution | 5.11.5 Medications to Avoid or Take with Caution The following medications must be avoided or taken with caution following discussion with the Sponsor: - Strong inhibitors or inducers of CYP3A4. - o Non-Medication CYP inhibitors, including the following herbal supplements and foods, must be avoided or taken with cautio... | [] |
NCT03717415 | 5.11.6 | Prohibited Medications and Substances | 5.11.6 Prohibited Medications and Substances The following medications must be excluded during the study: - Anticancer therapies, including investigational therapy, concurrent radiation therapy (with the exception of radiotherapy for palliative radiation due to pre-existing bone metastases), or any other investigationa... | [] |
NCT03717415 | 5.11.7 | Concomitant Procedures | 5.11.7 Concomitant Procedures All procedures performed on or after the first dose of study drug through and including FSV or initiation of new anticancer therapy after the last dose of study drug must be documented in the patient's source documents and the eCRF. Investigational procedures of any kind are excluded durin... | [] |
NCT03717415 | 5.12 | Other Precautions | 5.12 Other Precautions Formal photosensitivity studies have not been performed, however a potential for photoirritation/phototoxicity exists based absorption properties of rebastinib in the ultra violet visible range (above 290 nm). In order to mitigate the potential risk of photoirritation/phototoxicity, patients must... | [] |
NCT03717415 | 6 | STUDY ASSESSMENTS | 6 STUDY ASSESSMENTS The study specific assessments are detailed in this section and the Schedule of Assessments is outlined in [Table 1](#page-17-0) (Schedule of Assessments). Additional unscheduled safety or efficacy assessments may be performed at any time as clinically indicated to determine the relevance of specifi... | [] |
NCT03717415 | 6.1 | Screening | 6.1 Screening Screening must occur within 28 days prior to the first dose of study drug unless otherwise noted to confirm that patients meet the selection criteria for the study. The assessments to be conducted at screening are provided in [Table 1](#page-17-0) (Schedule of Assessments). | [] |
NCT03717415 | 6.2 | Treatment Period | 6.2 Treatment Period Patients will be registered in the study after confirmation of all eligibility criteria. The first dose of study drug must be administered in the clinic on Cycle 1 Day 1. Treatment period is defined as the time of first dose through the End of Treatment (EOT) visit. Study visits during the treatmen... | [] |
NCT03717415 | 6.3 | Follow Up Safety Visit | 6.3 Follow Up Safety Visit Patients will be contacted for the FSV 30 (+/-7) days after receiving their last dose of study drug or before the start of new anticancer therapy, whichever occurs first. The assessments to be conducted at this visit are provided in [Table 1](#page-17-0) (Schedule of Assessments). This visit ... | [] |
NCT03717415 | 6.4 | Lost to Follow Up | 6.4 Lost to Follow Up A patient will be considered lost to follow up if both of the following occur: - Patient misses two consecutive study visits and is subsequently unable to be contacted by phone call (after three documented attempts by phone within 2 weeks following the second missed visit). - Patient does not resp... | [] |
NCT03717415 | 6.5 | Informed Consent Procedure | 6.5 Informed Consent Procedure Each patient must sign and date a study-specific informed consent form (ICF) before any study specific procedures can be performed. The ICF will comply with all applicable regulations governing the protection of patients. An ICF, approved by the Sponsor and the site's Institutional Review... | [] |
NCT03717415 | 6.6 | Patient Identification and Registration | 6.6 Patient Identification and Registration A unique patient identification number (patient number) will be assigned to each patient once informed consent is obtained. If a patient is rescreened, the patient retains the original patient number. Patients who are candidates for enrollment into the study will be evaluated... | [] |
NCT03717415 | 6.7 | Demographics and Medical History | 6.7 Demographics and Medical History Demographic information must be collected at screening. Cancer history and prior treatment (including reason for discontinuation), must be obtained during screening. Cancer history will include: - Known histologic diagnosis - All prior cancer treatment regimens, including: - Surgery... | [] |
NCT03717415 | 6.8 | Safety | 6.8 Safety The safety profile will be assessed based on physical examinations; ECOG PS; changes from baseline in vital signs, ECGs, LVEF based on echocardiogram/multigated acquisition (MUGA) scan, ophthalmologic examination, and clinical laboratory tests; and the reporting of AEs and AESIs. The investigators and Sponso... | [] |
NCT03717415 | 6.8.1 | Dose-Limiting Toxicities | 6.8.1 Dose-Limiting Toxicities A DLT will be defined as any one of the following AEs during the first cycle of treatment occurring during Dose Escalation of the study up until the time of establishing the MTD or an RP2D, unless it is clearly and incontrovertibly due to disease progression or other identifiable extraneo... | [] |
NCT03717415 | 6.8.2 | Physical Examinations and Height and Weight | 6.8.2 Physical Examinations and Height and Weight Physical examination will be performed at screening and the EOT visit according to the Schedule of Assessments in [Table 1](#page-17-0). A full physical examination includes a review of the following systems: head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardio... | [] |
NCT03717415 | 6.8.3 | Eastern Cooperative Oncology Group (ECOG) Performance Status | 6.8.3 Eastern Cooperative Oncology Group (ECOG) Performance Status Eastern Cooperative Oncology Group (ECOG) PS ([31](#page-100-8)) will be assessed according to the Schedule of Assessments in [Table 1](#page-17-0). | [] |
NCT03717415 | 6.8.4 | Vital Signs, Weight, and Height | 6.8.4 Vital Signs, Weight, and Height Vital sign measurements, height, and weight will be performed according to the Schedule of Assessments in [Table 1.](#page-17-0) Vital sign measurements will consist of sitting blood pressure, heart rate, respiratory rate, and body temperature. These should be assessed following a ... | [] |
NCT03717415 | 6.8.5 | Electrocardiograms | 6.8.5 Electrocardiograms Digital, 12-lead ECGs will be performed with central over-reading according to the Schedule of Assessments in [Table 1.](#page-17-0) All sites will be provided with an ECG machine and associated materials by the central ECG diagnostic service. All ECG assessments for study treatment will be con... | [] |
NCT03717415 | 6.8.6 | Echocardiograms/Multigated Acquisition Scans | 6.8.6 Echocardiograms/Multigated Acquisition Scans Echocardiograms or MUGA scans will be performed according to the Schedule of Assessments in [Table 1.](#page-17-0) The same modality (echocardiogram or MUGA scan) must be used throughout the study. Left ventricular ejection fraction must be documented in the patient's ... | [] |
NCT03717415 | 6.8.7 | Ophthalmologic Examination | 6.8.7 Ophthalmologic Examination Ophthalmologic examinations will be performed by a licensed ophthalmologist according to the Schedule of Assessments in [Table 1.](#page-17-0) This examination does not have to be repeated during screening if there is documentation of an examination that met protocol criteria within 60 ... | [] |
NCT03717415 | 6.8.8 | Clinical Laboratory Tests | 6.8.8 Clinical Laboratory Tests Blood and urine samples will be collected according to the Schedule of Assessments in [Table 1](#page-17-0) and analyzed at the site's local laboratory. All blood samples must be collected while patients are in a seated or supine position. Laboratory test results that are abnormal and co... | [] |
NCT03717415 | 6.8.9 | Pregnancy Test | 6.8.9 Pregnancy Test A serum β-hCG test to rule out pregnancy in women of childbearing potential will be obtained at screening. A urine or serum pregnancy test will be performed pre-dose on Day 1 of every cycle and at the EOT visit as outlined in [Table 1](#page-17-0) (Schedule of Assessments). Pregnancy testing will n... | [] |
NCT03717415 | 6.8.10 | Contraception and Pregnancy Avoidance Measures | 6.8.10 Contraception and Pregnancy Avoidance Measures | [] |
NCT03717415 | 6.8.10.1 | Contraception | 6.8.10.1 Contraception The effects of rebastinib on sperm, conception, pregnancy, and lactation are not known. Participation in this study requires female patients to agree to use two methods of contraception, with one of the methods being highly effective, and male patients to agree to practice effective barrier contr... | [
"Additional notes:"
] |
NCT03717415 | 6.8.10.2 | Pregnancy | 6.8.10.2 Pregnancy Patients must be counseled to inform the Investigator of any pregnancy that occurs during study treatment and for 120 days after the last dose of the study drug. If a female patient becomes pregnant while participating in the study, study drug must be permanently discontinued immediately. If the fema... | [] |
NCT03717415 | 6.8.11 | Adverse Events | 6.8.11 Adverse Events All AEs will be assessed, documented, and reported in accordance with ICH Good Clinical Practice (GCP) guidelines. [Section 7](#page-77-0) outlines the definitions, collection periods, criteria and procedures for documenting, grading, and reporting AEs. | [] |
NCT03717415 | 6.8.12 | Safety Follow Up | 6.8.12 Safety Follow Up All patients must be followed for AEs; medications, including any anticancer treatments; and procedures from last dose of study drug through the FSV (30 [+/-7] days after last dose of study drug) or before the start of new anticancer therapy, whichever occurs first. | [] |
NCT03717415 | 6.9 | Pharmacokinetics | 6.9 Pharmacokinetics | [] |
NCT03717415 | 6.9.1 | Sample Collection | 6.9.1 Sample Collection At the visits indicated in [Table 1](#page-17-0) (Schedule of Assessments) and [Table 2,](#page-21-1) blood samples will be collected for the determination of the concentrations of rebastinib and carboplatin. Details on sample collection, processing, and shipping will be provided in a separate p... | [] |
NCT03717415 | 6.9.2 | Sample Assessment | 6.9.2 Sample Assessment The following PK parameters will be calculated using non-compartmental methods of plasma rebastinib and carboplatin, obtained after single and repeated dose administration. The parameters will include, but may not be limited to Cmax, Time to maximum observed concentration (Tmax), AUC, and T1/2. | [] |
NCT03717415 | 6.10 | Efficacy | 6.10 Efficacy | [] |
NCT03717415 | 6.10.1 | Radiologic Imaging | 6.10.1 Radiologic Imaging All patients will have radiographic tumor evaluation by CT scans of the chest, abdomen, and pelvis according to the Schedule of Assessments in [Table 1.](#page-17-0) Magnetic resonance imaging (MRI) or CT scans without contrast may be used for patients who are allergic to radiographic contrast... | [] |
NCT03717415 | 6.10.2 | Response Assessment Using CA-125 (Ovarian Cancer Patients Only) | 6.10.2 Response Assessment Using CA-125 (Ovarian Cancer Patients Only) CA-125 will be collected for all patients with ovarian cancer according to the Schedule of Assessments in [Table 1.](#page-17-0) Ovarian cancer patients experiencing CA-125 response must have a confirmatory test performed at least 28 days after init... | [] |
NCT03717415 | 6.10.3 | Relevant Tumor Markers | 6.10.3 Relevant Tumor Markers Data of relevant tumor markers (examples: cancer antigen (CA)-15.3, CA-19-9, CA-27.29, prostate-specific antigen, and carcinoembryonic antigen) performed as standard of care will be collected. | [] |
NCT03717415 | 6.11 | Biomarker Research Studies | 6.11 Biomarker Research Studies | [] |
NCT03717415 | 6.11.1 | Sample Collection | 6.11.1 Sample Collection Biomarker samples will be collected according to the schedule in [Table 1](#page-17-0) (Schedule of Assessments). Sampling may be discontinued at any time by the Sponsor contingent on data. A Laboratory Manual describing the details of obtaining, storing, and shipping the samples will be provid... | [] |
NCT03717415 | 6.11.2 | Sample Assessments | 6.11.2 Sample Assessments | [] |
NCT03717415 | 6.11.2.1 | Tumor Tissue Samples | 6.11.2.1 Tumor Tissue Samples At screening, an archival tumor tissue sample is required for all patients enrolled onto the study. If archival tumor tissue is unavailable, a fresh tumor biopsy will be collected prior to the first dose of study drug. Additionally, a fresh tumor biopsy will be collected at Cycle 3 Day 1 (... | [] |
NCT03717415 | 6.11.2.2 | Whole Blood and Plasma Samples | 6.11.2.2 Whole Blood and Plasma Samples Whole blood samples will be collected for immunophenotyping of peripheral blood mononuclear cells according to the Schedule of Assessments in [Table 1.](#page-17-0) Plasma samples will be collected to measure circulating levels of chemokines/cytokines. Changes in chemokines/cytok... | [] |
NCT03717415 | 6.12 | Pharmacogenomic Measurements | 6.12 Pharmacogenomic Measurements | [] |
NCT03717415 | 6.12.1 | Sample Collection | 6.12.1 Sample Collection A pharmacogenomic sample will be collected according to the schedule of study assessments in [Table 1](#page-17-0) (Schedule of Assessments). A Laboratory Manual describing the details of obtaining, storing, and shipping the sample will be provided. | [] |
NCT03717415 | 6.12.2 | Sample Assessment | 6.12.2 Sample Assessment Pharmacogenomic samples will be used to assess polymorphisms in genes encoding drug metabolic enzymes and/or transporters involved in metabolism and disposition of rebastinib in combination with carboplatin. Additionally, polymorphisms in genes that may be associated with clinical response and/... | [] |
NCT03717415 | 6.13 | Patient Reported Outcome (PRO) Measurements | 6.13 Patient Reported Outcome (PRO) Measurements Patients will be asked to complete PRO assessments in the form of questionnaires using an electronic data capture system (electronic PRO [ePRO] device) according to the Schedule of Assessments in [Table 1.](#page-17-0) Only English-speaking patients will complete the que... | [] |
NCT03717415 | 6.13.1 | National Cancer Institute (NCI) Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | 6.13.1 National Cancer Institute (NCI) Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) The NCI PRO-CTCAE measurement system was developed to gather symptomatic AEs by patient self-reporting ([33](#page-100-9)). The PRO-CTCAE library is comprised of 124 items represent... | [] |
NCT03717415 | 6.13.2 | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-item (EORTC QLQ-C30) | 6.13.2 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-item (EORTC QLQ-C30) The EORTC QLQ-C30 is a validated, standardized, patient-completed questionnaire used extensively in international clinical studies. It was developed to assess health-related QOL in patients... | [] |
NCT03717415 | 6.13.3 | GP5 from Functional Assessment of Cancer Therapy – General (FACT-G) | 6.13.3 GP5 from Functional Assessment of Cancer Therapy – General (FACT-G) The GP5 burden-of-side-effects, a part of the Functional Assessment of Chronic Illness Therapy (FACIT) FACT-G questionnaire, is a validated, standardized, patient-completed question used extensively in international clinical studies [\(35\)](#pa... | [] |
NCT03717415 | 7 | ADVERSE EVENT AND SERIOUS ADVERSE EVENT DOCUMENTATION, SEVERITY GRADING, AND REPORTING | 7 ADVERSE EVENT AND SERIOUS ADVERSE EVENT DOCUMENTATION, SEVERITY GRADING, AND REPORTING | [] |
NCT03717415 | 7.1 | Adverse Events | 7.1 Adverse Events An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. An AE can be any unfavorable and unintended sign (e.g., including an abnormal laboratory finding), sympto... | [] |
NCT03717415 | 7.2 | Severity Assessment | 7.2 Severity Assessment The Investigator must determine and record the severity of all serious and non-serious AEs. The NCI CTCAE Version 5.0 must be used for grading the severity of AEs (Cancer Therapy Evaluation Program website). The severity of an AE that does not appear in the CTCAE scale must be determined accordi... | [] |
NCT03717415 | 7.3 | Causality Assessment | 7.3 Causality Assessment The Investigator's assessment of relationship of the AE, if any to the study drug must be provided for all AEs. An Investigator's causality assessment is the determination of whether there is reasonable possibility that the study drug caused or contributed to an AE. Relationship to each study d... | [] |
NCT03717415 | 7.4 | Study Drug Action Taken | 7.4 Study Drug Action Taken The Investigator must classify the study drug action taken with regard to the AE. The action taken must be classified according to the categories shown in [Table 17.](#page-78-3) Table 17: Classification for Study Drug Action Taken with Regard to an Adverse Event | Classification | Definitio... | [] |
NCT03717415 | 7.5 | Adverse Event Outcome | 7.5 Adverse Event Outcome An AE must be followed until the Investigator has determined and provided the final outcome. The outcome must be classified according to the categories shown in [Table 18](#page-79-4). Table 18: Classifications for Outcome of an Adverse Event | Classification | Definition | | | |--------------... | [] |
NCT03717415 | 7.6 | Treatment Given | 7.6 Treatment Given The Investigator must ensure adequate medical care is provided to patients for any AEs. In addition, the Investigator must describe whether any treatment was given for the AE. "Yes" is used if any treatment was given in response to an AE and may include treatments such as other medications, hospital... | [] |
NCT03717415 | 7.7 | Additional Points to Consider for Adverse Events | 7.7 Additional Points to Consider for Adverse Events | [] |
NCT03717415 | 7.7.1 | Clinically Significant Assessments | 7.7.1 Clinically Significant Assessments Study assessments including laboratory tests, ECGs, physical examinations, and vital signs must be assessed, and those deemed as clinically significant must be documented as an AE. When possible, a clinical diagnosis for the study assessment must be provided rather than the abno... | [] |
NCT03717415 | 7.8 | Serious Adverse Events | 7.8 Serious Adverse Events An AE is considered serious if it meets any of the following: - Results in death (regardless of cause, that occurs during participation in the study or occurs after participation in the study and is suspected of being a delayed toxicity due to administration of the study drug). - Is life thre... | [] |
NCT03717415 | 7.9 | Adverse Events of Special Interest for Study Drug | 7.9 Adverse Events of Special Interest for Study Drug An AESI is an AE (serious or nonserious) of scientific and medical concern specific to study drug, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor is required. Such AEs may require further investigation to characterize and ... | [] |
NCT03717415 | 7.10 | Adverse Event Reporting Periods | 7.10 Adverse Event Reporting Periods The AE (including SAEs and AESIs) reporting period begins from the time that the patient provides informed consent through and including 30 days after the last administration of the study drug for all enrolled patients. Any SAE or AESI occurring after the reporting period must be pr... | [] |
NCT03717415 | 7.11 | Adverse Event and Serious Adverse Event Reporting Requirements | 7.11 Adverse Event and Serious Adverse Event Reporting Requirements Each patient must be carefully monitored for the development of any AEs. This information must be obtained in the form of non-leading questions (e.g., "How are you feeling?") and from signs and symptoms detected during each examination, observations of... | [] |
NCT03717415 | 7.12 | Abuse, Misuse, Overdose, and Medication Error | 7.12 Abuse, Misuse, Overdose, and Medication Error Occurrences of events of overdose, drug misuse, drug abuse and medication error must be reported to the Sponsor. Abuse of a medicinal product: Persistent or sporadic, intentional excessive use of medicinal products, which is accompanied by harmful physical or psycholog... | [] |
NCT03717415 | 8 | DISCONTINUATION AND REPLACEMENT OF PATIENTS | 8 DISCONTINUATION AND REPLACEMENT OF PATIENTS | [] |
NCT03717415 | 8.1 | Discontinuation of Treatment | 8.1 Discontinuation of Treatment A patient is free to withdraw from the study drug treatment for any reason and at any time without giving reason for doing so and without penalty or prejudice. The Investigator is also free to terminate a patient's study drug treatment at any time if the patient's clinical condition war... | [] |
NCT03717415 | 8.2 | Follow Up Safety Visit / End of Study | 8.2 Follow Up Safety Visit / End of Study The end of study is defined as the date when the patient has withdrawn or completed through the FSV. If the patient is unable to complete the FSV, the reason will be captured in the clinical database using the following categories: - New Anticancer Treatment - Death - Lost to F... | [] |
NCT03717415 | 8.3 | Replacement of Patients | 8.3 Replacement of Patients In the Dose Escalation phase, patients must receive ≥80% of planned doses of rebastinib and one dose of carboplatin in Cycle 1 to be considered for determination of RP2D unless patients experienced a DLT(s). Patients who do not receive the requisite amount of the combination will be replaced... | [] |
NCT03717415 | 9 | STATISTICAL CONSIDERATIONS | 9 STATISTICAL CONSIDERATIONS | [] |
NCT03717415 | 9.1 | Determination of Sample Size | 9.1 Determination of Sample Size Dose Escalation: The Dose Escalation phase will primarily be used to determine the MTD or an RP2D and evaluate the safety and tolerability of the combination using modified 3+3 dose escalation rules. Three dose escalation cohorts are planned, and an additional cohort may be added. Appro... | [] |
NCT03717415 | 9.2 | Analysis Endpoints | 9.2 Analysis Endpoints | [] |
NCT03717415 | 9.2.1 | Safety | 9.2.1 Safety Safety endpoints include: - DLTs in the Dose Escalation Phase - AEs - SAEs - AESIs - Dose reduction or discontinuation of study drug due to toxicity - Physical examinations - ECOG PS - Ophthalmic examinations - Changes from baseline in laboratory parameters - ECGs - Echocardiograms/MUGAs - Vital signs | [] |
NCT03717415 | 9.2.2 | Pharmacokinetics | 9.2.2 Pharmacokinetics Pharmacokinetic endpoints when rebastinib is administered in combination with carboplatin and as a single agent include, but are not limited to: - Tmax (rebastinib only) - Time to maximum observed concentration at steady state (Tmax,ss: rebastinib only) - Maximum observed concentration (Cmax) - M... | [] |
NCT03717415 | 9.2.3 | Efficacy | 9.2.3 Efficacy Radiographic tumor assessments (computed tomography [CT] or MRI) will be performed by RECIST Version 1.1 or mRECIST (pleural mesothelioma only). For ovarian patients, additional response assessments will be performed using RECIST Version 1.1 and CA-125 response criteria by the GCIG guideline [\(31](#page... | [] |
NCT03717415 | 9.2.4 | Pharmacogenomics | 9.2.4 Pharmacogenomics The pharmacogenomics endpoints of the study include, but are not limited to: • Assessment of polymorphisms in genes that may be associated with clinical response and/or study drug-related toxicity | [] |
NCT03717415 | 9.2.5 | Pharmacodynamics | 9.2.5 Pharmacodynamics The pharmacodynamic endpoints of the study include, but are not limited to: - Assess changes of plasma chemokines/cytokines upon treatment - Assess changes in monocyte population in peripheral blood - Evaluate changes in tumor microenvironment using tumor tissue, if obtained, including but not li... | [] |
NCT03717415 | 9.2.6 | Patient Reported Outcomes | 9.2.6 Patient Reported Outcomes Assess the safety profile of rebastinib in combination with carboplatin using certain questions from the NCI PRO-CTCAE, a treatment-bother question (GP5) from FACIT's FACT-G, as well as the EORTC QLQ-C30. | [] |
NCT03717415 | 9.3 | Populations for Analysis | 9.3 Populations for Analysis Enrolled Population: The Enrolled Population contains all patients who signed the ICF. Safety Population: The Safety Population is defined as all patients who have received at least one dose of either study drug. Safety Population will be used for all safety analysis. Modified intent-to-tre... | [] |
NCT03717415 | 9.4 | Procedures for Handling Missing, Unused, and Spurious Data | 9.4 Procedures for Handling Missing, Unused, and Spurious Data Unless specified in the individual endpoint analysis, missing data will not be imputed in except for identification of TEAEs and none study drug medication with missing start or end time. All available data will be presented on the data listings as collecte... | [] |
NCT03717415 | 9.5 | Interim Analyses | 9.5 Interim Analyses No interim analysis for efficacy will be performed for this study. | [] |
NCT03717415 | 9.6 | Adjustment for Multiple Comparisons | 9.6 Adjustment for Multiple Comparisons Due to the exploratory nature of the study, adjustments for multiplicity will not be made. | [] |
NCT03717415 | 9.7 | Blinding | 9.7 Blinding This is an open-label study. | [] |
NCT03717415 | 9.8 | Statistical Methods | 9.8 Statistical Methods | [] |
NCT03717415 | 9.8.1 | General Methods | 9.8.1 General Methods Data collected in this study will be documented using summary tables and patient data listings. Continuous variables will be summarized using descriptive statistics (number of patients, mean, median, standard deviation, minimum, and maximum). Categorical variables will be summarized using frequenc... | [] |
NCT03717415 | 9.8.2 | Disposition of Patients | 9.8.2 Disposition of Patients Patient disposition will be summarized overall for all patients who entered the study (i.e., signed the informed consent for the study). In addition, the number of patients in each population (Enrolled, Safety, and mITT) and patients that were removed from a population will be summarized. ... | [] |
NCT03717415 | 9.8.3 | Demographic and Baseline Characteristics | 9.8.3 Demographic and Baseline Characteristics Demographic and baseline characteristics at study entry will be summarized by for the Safety and mITT Populations for each study cohort. | [] |
NCT03717415 | 9.8.4 | Extent of Exposure | 9.8.4 Extent of Exposure The total number of patients who received either study medication will be summarized by n and percentage. In addition, the number of cycles received will be displayed using continuous descriptive statistics. These analyses will be performed for the Safety Population. | [] |
NCT03717415 | 9.9 | Efficacy Analysis | 9.9 Efficacy Analysis Efficacy analysis for the dose escalation and expansion cohorts will be performed separately. For the dose expansion, efficacy analysis will be done by cohort. Additionally, analysis may be done by including dose-escalation patients who met the inclusion criteria and received the same dose level a... | [] |
NCT03717415 | 9.9.1 | Primary Endpoint | 9.9.1 Primary Endpoint The primary endpoint, ORR, defined as the proportion of patients with a CR or PR, will be analyzed in the mITT population as the primary analysis. Patients with unknown or missing response will be treated as non-responders, that is, they will be included in the denominator when calculating the pr... | [] |
NCT03717415 | 9.10 | Secondary Endpoints | 9.10 Secondary Endpoints | [] |
NCT03717415 | 9.10.1 | Progression-free Survival | 9.10.1 Progression-free Survival The PFS (reported in weeks) is defined as the interval between the date of initial dose and the earliest documented evidence of disease progression based on Investigator review, or death due to any cause. Patients who undergo surgical resection of target or non-target lesions, who have ... | [] |
NCT03717415 | 9.10.2 | Time to Tumor Progression | 9.10.2 Time to Tumor Progression The secondary endpoint of TTP (reported in weeks) is defined as the interval between the date of initial dose and the earliest documented evidence of disease progression based on Investigator review. Patients who undergo surgical resection of target or non-target lesions, who have recei... | [] |
NCT03717415 | 9.10.3 | Overall Survival | 9.10.3 Overall Survival Overall survival (reported in weeks) is defined as the interval between the date of initial dose and date of death from any cause. Patients who are still alive or who are lost to follow-up will be censored at the date of last contact. Summaries for each cohort will be provided using the methods ... | [] |
NCT03717415 | 9.10.4 | Time to Response | 9.10.4 Time to Response The time to response, as defined by the Investigator review, will be summarized and displayed using the methods of KM, and will include medians with 2-sided 90% CIs. | [] |
NCT03717415 | 9.10.5 | Clinical Benefit Rate | 9.10.5 Clinical Benefit Rate Clinical benefit rate (CBR) will be calculated and summarized with n and percentage at 6, 12, and 18 weeks. Clinical benefit will be defined as having a response (complete or partial) or SD. Proportions with exact 2-sided 90% CIs will be reported for each cohort. | [] |
NCT03717415 | 9.10.6 | Duration of Response | 9.10.6 Duration of Response Duration of response, defined as the time from first PR or CR to disease progression or death, will be calculated for patients who have PR or CR. DOR will be presented using descriptive statistics. Summaries for each cohort will be provided using the methods of KM, and will include medians w... | [] |
NCT03717415 | 9.11 | Safety Analysis | 9.11 Safety Analysis | [] |
NCT03717415 | 9.11.1 | Adverse Events | 9.11.1 Adverse Events AEs will be summarized utilizing the number and proportion of patients by system organ class and preferred term for the Safety Population. All tables will only include TEAEs, where treatment emergent is defined as any AE that occurs after administration of the first dose of study drug and through ... | [] |
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