Trial · NCT02014636
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs ) | From the start of study treatment (first dose) and, until the post-treatment follow-up visit (at least 30 days after the last dose of investigational product) for AEs, and until 90 days after last dose for SAEs | |
| Primary | Part 1: To determine the dose limiting toxicity (DLT) and maximum tolerated regimen (MTR) | 8 weeks | MTR is defined as the highest dose of pazopanib in combination with the highest dose of MK 3475 at which no more than 1 of 6 subjects experiences a DLT after a minimum of 8 weeks of treatment. DLT is defined as a drug-related AE starting in the first 8 weeks of treatment |
| Primary | Part 1: Number of subjects with permanent discontinuation of treatment, dose reductions, interruptions, or delays | 24 months | |
| Primary | Part 1: Change from baseline in laboratory parameters | Average of 4 years | Laboratory assessments include haematology, clinical chemistry, urine, coagulation and thyroid function test |
| Primary | Part 1: Change from baseline in vital signs | 30 days after the last dose of study treatment | Vital sign measurements will include heart rate, temperature and blood pressure |
| Primary | Part 1: Change from baseline in cardiac parameters | 24 months | Cardiac assessments will include Electrocardiogram (ECG) and Echocardiograms (ECHOs) |
| Primary | Part 1: Incidence and titer of anti MK 3475 antibodies | 24 months | Subjects will be monitored for anti-MK 3475 antibodies throughout the study |
| Primary | Part 2: Progression-free survival (PFS) | Average of 4 years | PFS is defined as the interval between the date of randomization and the earlier date of disease progression (using RECIST v1.1) or death due to any cause. |
| Secondary | Part 1: Dose escalation cohorts: pazopanib plasma concentrations and serum MK 3475 concentrations. | For Pazopanib: before and after the 1st and 2nd dose of MK-3475. For MK-3475: Until 6 months after the last dose of MK-3475 | For analysis of plasma pazopanib and serum MK 3475 concentrations, blood samples will be collected from all subjects |
| Secondary | Part 1: Pharmacokinetic (PK) parameters in Expansion cohort | For Pazopanib: before and after the 1st and 2nd dose of MK-3475. For MK-3475: Until 6 months after the last dose of MK-3475 | Area under the plasma concentration-time curve from time 0 to 24 hrs (AUC\[0-24\], maximum observed concentration (Cmax), tmax, and concentration at 24 hours (C24) of pazopanib; Pre-dose (trough) concentration at the end of the dosing interval (Ctau), and apparent clearance following oral dosing CL/F of pazopanib will be determined if data permit. |
| Secondary | Part 1 and Part 2: Overall response rate (ORR) | Average of 4 years | Overall response rate is defined as the percentage of subjects, who achieved either a confirmed complete response (CR) or partial response (PR) by RECIST v1.1 and modified RECIST |
| Secondary | Part 1 and Part 2: Clinical benefit rate | Average of 4 years | Clinical benefit rate is defined as a confirmed response of CR or PR or at least 6-months stable disease by RECIST v1.1 and modified RECIST. |
| Secondary | Part 1 and Part 2: Time to response | Average of 4 years | Time to response is defined for all subjects with a confirmed CR or PR as per RECIST v1.1as the time from randomization until the first documented evidence of CR or PR (whichever status is recorded first) |
| Secondary | Part 1 and Part 2: Duration of response | Average of 4 years | Duration of response is defined for all subjects with confirmed CR or PR as the time from the first documented evidence of CR or PR until time of first documented disease progression or death due to any causes, whichever is first by RECIST v1.1 and modified RECIST |
| Secondary | Part 2: PFS by modified RECIST | Average of 4 years | |
| Secondary | Part 1 and Part 2: Progression-free survival rate at 18 months (PFSR18) | 18 months | PFSR18 will be calculated based on Kaplan-Meier estimates of Progression-free survival (PFS) at 18 months by RECIST v1.1 and modified RECIST |
| Secondary | Part 2: Overall survival (OS) at 18 months | 18 months | Overall survival at 18 months will be summarized based on the Kaplan-Meier method. |
| Secondary | Part 2: Overall survival (OS) | Average of 4 years | Overall survival will be summarized using Kaplan-Meier survival curves |
| Secondary | Part 2: Incidence and severity of AEs and SAEs | From the start of study treatment (first dose) and, until the post-treatment follow-up visit (at least 30 days after the last dose of investigational product) for AEs, and until 90 days after last dose for SAEs | |
| Secondary | Part 2: Number of subjects with permanent discontinuation of treatment, dose reductions, interruptions, or delays | Average of 4 years |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02014636/registered