| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01064310 | Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney Cancer | PHASE3 | COMPLETED | 169 | — | — | May 17, 2010 | Nov 23, 2015 | Apr 17, 2017 | 51 | Finland, France +3 |
| NCT00720941 | Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma | PHASE3 | COMPLETED | 1,110 | — | — | Aug 14, 2008 | Mar 24, 2021 | Mar 30, 2025 | 227 | United States, Australia +12 |
| NCT01147822 | Pazopanib Versus Sunitinib in the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma | PHASE2 | COMPLETED | 367 | — | — | May 19, 2010 | Sep 3, 2021 | Mar 28, 2025 | 21 | China, South Korea +1 |
| NCT02014636 | Safety and Efficacy Study of Pazopanib and MK 3475 in Advanced Renal Cell Carcinoma (RCC; KEYNOTE-018) | PHASE1 | COMPLETED | 42 | — | — | Dec 27, 2013 | Feb 27, 2019 | Mar 3, 2020 | 6 | United States, United Kingdom |
| NCT00387205 | Study To Assess Long Term Safety Of Pazopanib | PHASE1 | COMPLETED | 188 | — | — | Jun 20, 2006 | Mar 8, 2018 | Mar 6, 2019 | 19 | United States, France +2 |
The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
PFS was defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a \>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of \>=1 new lesion.
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
Laboratory assessments include haematology, clinical chemistry, urine, coagulation and thyroid function test
Vital sign measurements will include heart rate, temperature and blood pressure
Cardiac assessments will include Electrocardiogram (ECG) and Echocardiograms (ECHOs)
Subjects will be monitored for anti-MK 3475 antibodies throughout the study
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.
To evaluate the safety assessments; adverse events, vital signs, physical examinations, electrocardiograms, multi-gated acquisition scans or echocardiograms (only for patients on pazopanib and lapatinib combination therapy), and clinical laboratory assessments.
| Arm | Type | Description |
|---|---|---|
| pazopanib followed by sunitinib | EXPERIMENTAL | 800mg pazopanib orally for 10 weeks followed by 50mg sunitinib orally for 10 weeks |
| sunitinib followed by pazopanib | EXPERIMENTAL | 50mg sunitinib orally for 10 weeks followed by 800mg pazopanib orally for 10 weeks |
| Sunitinib | ACTIVE_COMPARATOR | Control arm |
| Pazopanib | EXPERIMENTAL | Experimental arm |
| Part 1 | EXPERIMENTAL | Part 1 is a dose escalation phase in which subjects will receive pazopanib orally and the MK 3475 intravenously. Subjects will be evaluated for a minimum of 8 weeks before the next dose level cohort is enrolled. |
| Part 2 | EXPERIMENTAL | Part 2 is a randomized phase in which subjects will be enrolled in each treatment arm: Pazopanib monotherapy Pazopanib+MK-3475 MK-3475 monotherapy |
| Arm 1 | EXPERIMENTAL | Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications |
| Name | Type | Description |
|---|---|---|
| pazopanib | DRUG | oral anti-angiogenic treatment |
| sunitinib | DRUG | oral anti-angiogenic treatment |
| MK-3475 | DRUG | MK 3475 is an intravenously administered 100 mg/ 4mL solution available in the potential dose range of 1 to 10 mg/kg. |
Inclusion Criteria: * Patients must provide written informed consent prior to performance of any study-specific procedures or assessments and must be willing to comply with treatment and follow up. Procedures conducted as part of the patient's routine clinical management (e.g. blood count, imaging ...