Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for use in renal cell carcinoma, macular degeneration, and peritoneal cancer. It is in Phase 2 clinical development for oncology indications. The drug is not approved and remains under investigation in clinical trials.
GW786034 is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials of the drug across multiple oncology indications, including renal cell carcinoma.
GW786034 is in Phase 2 clinical development. It has completed five clinical trials, including Phase 1 and Phase 2 studies, with a total enrollment of 434 participants. The drug is investigational and has not been approved.
GW786034 has completed five clinical trials, including NCT00158782, a Phase 1 study with lapatinib in cancer patients; NCT00256880, a Phase 2 study in relapsed or refractory multiple myeloma; NCT00401583, a drug interaction study; and NCT00478725, a radiolabel study.
Yes, GW786034 is also known as pazopanib. Clinical trial titles refer to the drug as pazopanib (GW786034), confirming that both names identify the same investigational compound being developed by GSK plc.