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Also known as GW786034 (pazopanib), pazopanib
GW786034 · 7 trials · 6 indications
Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response=≥50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 \>21U/mL) or non-normalized (CA-125≤1U/mL). Progressive disease (PD) =CA-125 increase ≥100% from nadir (nadir \>21U/mL) or ≥42U/mL (nadir ≤21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do not meet 50% response or PD. CA-125 response rate was defined as % of participants with 50% response.
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 | 800 mg GW786034 administered orally on a daily basis. |
| 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. |
| 5 mg | EXPERIMENTAL | GW786034 |
| 10 mg | EXPERIMENTAL | GW786034 |
| 20 mg | EXPERIMENTAL | GW786034 |
| 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 | 800 mg GW786034 administered orally on a daily basis. |
| 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: * Confirmed diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma. * Has received one prior platinum-based chemotherapy regimen(cisplatin,carboplatin, or oxaliplatin). * Has psychological, familial, sociological or geographical condition that does not p...
GW786034 is an investigational small molecule developed by GSK plc, also known as pazopanib. It has been studied in Phase 1 and Phase 2 clinical trials for conditions including renal cell carcinoma, macular degeneration, and peritoneal cancer. It is not described as approved and remains in clinical development.
GW786034 has been evaluated in clinical trials for renal cell carcinoma, macular degeneration, peritoneal cancer, and ovarian cancer. These studies include Phase 1 and Phase 2 trials. It is an investigational agent and is not described as approved for any indication.
GW786034 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the clinical trials of GW786034, including Phase 1 studies in healthy volunteers and patients with renal cell carcinoma, and a Phase 2 study in ovarian and peritoneal cancers.
GW786034 is in Phase 2 development. Five clinical trials have been completed, including four Phase 1 studies and one Phase 2 study, with no active trials reported. It is an investigational drug and is not described as approved.
Completed trials of GW786034 include NCT01051700 in macular degeneration, NCT00478725 and NCT00401583 in renal cell carcinoma, and NCT00281632, a Phase 2 study in ovarian, peritoneal, and fallopian tube cancers. Total enrollment across these studies was 434 participants.
Yes, GW786034 is also known as pazopanib. The names refer to the same investigational small molecule developed by GSK plc. Clinical trial records use both GW786034 and pazopanib when describing the same studies in renal cell carcinoma, macular degeneration, and peritoneal cancer.