Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00244764 | GW786034 In Subjects With Locally Recurrent Or Metastatic Clear Cell Renal Cell Carcinoma | PHASE2 | COMPLETED | 225 | — | — | Oct 1, 2005 | Sep 1, 2013 | Mar 27, 2017 | 45 | United States, Australia +6 |
| NCT00256880 | Pazopanib (GW786034) In Subjects With Relapsed Or Refractory Multiple Myeloma | PHASE2 | COMPLETED | 100 | — | — | Jan 1, 2005 | Dec 1, 2005 | Jan 18, 2017 | 8 | United States, Australia |
| NCT00478725 | Part A: Radiolabel Study With GW786034 Part B: Single Dose of GW786034 | PHASE1 | COMPLETED | 10 | — | — | Jul 18, 2007 | Jul 1, 2008 | Nov 17, 2017 | 2 | United States |
| NCT00401583 | A Study To Test The Effect Of GW786034 (Pazopanib) On P450 Enzymes | PHASE1 | COMPLETED | 24 | — | — | Jul 28, 2006 | Feb 20, 2008 | Nov 13, 2017 | 2 | United States, Singapore |
| NCT00158782 | Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients | PHASE1 | COMPLETED | 75 | — | — | Sep 28, 2004 | Aug 21, 2007 | Nov 17, 2017 | 2 | United States, Netherlands |
The overall response is the number of participants who experience a confirmed complete (CR) or partial response (PR) of the total analysis population. Per the Response Evaluation Criteria In Solid Tumors (RECIST): CR = all detectable tumor has disappeared, PR = a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum, Progressive disease (PD) = a \>=20% increase in target lesions, Stable Disease = small changes that do not meet previously given criteria.
The protocol called for an interim analysis of the first 60 participants to determine their status at Week 12, and to determine the number of participants with stable disease, although all categories were reported. Stable disease is defined as a disease that has not grown enough to be called progressive disease and has not shrunk enough to be called partial/complete response.
| Arm | Type | Description |
|---|---|---|
| Pazopanib | EXPERIMENTAL | All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib. |
| Placebo | PLACEBO_COMPARATOR | All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib. |
| Part A | EXPERIMENTAL | Absorption, Distribution, Metabolism and Elimination of a Single Oral \[14C\] Labeled Dose of GW786034 |
| Part B | EXPERIMENTAL | characterize the pharmacokinetics of a single IV dose of GW786034 |
| Pazopanib receivers | EXPERIMENTAL | During Days 1 and 2 subjects will be dosed with only probe drugs, and with no drugs on Days 3-5. During Days 6 to the end of the study, subjects will receive 800 mg daily pazopanib, and on Days 23-24 subjects will receive probe drugs in addition to pazopanib |
| Cohort 1 | EXPERIMENTAL | Subjects will receive GW786034 500 milligrams and lapatinib 750 milligrams. |
| Cohort 2 | EXPERIMENTAL | Subjects will receive GW786034 250 milligrams and lapatinib 750 milligrams. |
| Cohort 3 | EXPERIMENTAL | Subjects will receive GW786034 250 milligrams and lapatinib 1000 milligrams. |
| Cohort 4 | EXPERIMENTAL | Subjects will receive GW786034 500 milligrams and lapatinib 1000 milligrams. |
| Cohort 5 | EXPERIMENTAL | Subjects will receive GW786034 250 milligrams and lapatinib 1250 milligrams. |
| Cohort 6 | EXPERIMENTAL | Subjects will receive GW786034 400 milligrams and lapatinib 1250 milligrams. |
| Cohort 7 | EXPERIMENTAL | Subjects will receive GW786034 200 milligrams and lapatinib 1500 milligrams. |
| Cohort 8 | EXPERIMENTAL | Subjects will receive GW786034 400 milligrams and lapatinib 1500 milligrams. |
| Cohort 9 | EXPERIMENTAL | Subjects will receive GW786034 400 milligrams and lapatinib 1000 milligrams. |
| Cohort 10 | EXPERIMENTAL | Subjects will receive GW786034 800 milligrams and lapatinib 1500 milligrams. |
| Name | Type | Description |
|---|---|---|
| GW786034 | DRUG | All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib. |
| Placebo | DRUG | All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib. |
| GW786034, oral | DRUG | oral, 800 mg |
| GW786034, IV | DRUG | IV, 5 mg |
| GW786034, radiolabeled oral | DRUG | oral, 400 mg radiolabeled |
| GW786034 (pazopanib) | DRUG | Pazopanib will be given as monohydrochloride, 100 and 500 mg tablets. |
| Probe drugs | DRUG | probe drugs will be oral midazolam (3 mg), warfarin (10 mg), omeprazole (40 mg), caffeine (200 mg), and dextromethorphan (30 mg). |
| lapatinib | DRUG | Lapatinib is an oral, reversible, tyrosine kinase inhibitor of both epidermal growth factor receptor-1 (ErbB1) and ErbB2. |
Inclusion criteria: * Histologically or cytologically confirmed diagnosis of Renal Cell Carcinoma of predominantly clear-cell histology (excluding chromophobe, papillary, collecting duct, and undifferentiated tumors) which is metastatic or locally recurrent * Either no prior systemic therapy or fai...