Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GDC-0032 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Bioavailability | EXPERIMENTAL | - |
| Elimination & PK | EXPERIMENTAL | - |
| Arm A: GDC-0032 + Docetaxel | EXPERIMENTAL | Participants will receive GDC-0032 once daily for 21 consecutive days (beginning from Day 1) in each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle. |
| Arm B: GDC-0032 + Paclitaxel | EXPERIMENTAL | Participants will receive GDC-0032 once daily for 28 consecutive days (beginning from Day 1) in each 28-day cycle along with Paclitaxel on Days 1, 8, 15 and 22 of each 28-day cycle. |
| Arm C: GDC-0032 + Docetaxel | EXPERIMENTAL | Participants will receive GDC-0032 once daily on Day 1 and Days 8-14 of each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle. |
| Arm D: GDC-0032 + Docetaxel | EXPERIMENTAL | Participants will receive GDC-0032 once daily on Days 2-14 of each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle. |
| Arm E: GDC-0032 + Docetaxel | EXPERIMENTAL | Participants will receive GDC-0032 once daily on Days 1-14 of each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle. |
| Arm F: GDC-0032 + Paclitaxel | EXPERIMENTAL | Participants will receive GDC-0032 once daily on a 5-days on, 2-days off schedule in each 28-day cycle along with Paclitaxel on Days 1, 8, 5 and 22 of each 28-day cycle. |
| Arm G: GDC-0032 + Paclitaxel | EXPERIMENTAL | Participants will receive GDC-0032 once daily on a 3-days on, 4-days off schedule in each 28-day cycle along with Paclitaxel on Days 1, 8, 5 and 22 of each 28-day cycle. |
| Itraconazole Arm | EXPERIMENTAL | - |
| Rifampin Arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GDC-0032 | DRUG | Single oral dose |
| Docetaxel | DRUG | Participants will receive docetaxel 75 milligrams per meter-squared (mg/m\^2) intravenous (IV) dose on Day 1 of each 21-day cycle. |
| Paclitaxel | DRUG | Participants will receive paclitaxel 80 mg/m\^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle. |
| Itraconazole | DRUG | Oral doses of Itraconazole |
| Rifampin | DRUG | Oral doses of Rifampin |
Inclusion Criteria: * Body Mass Index (BMI) 18 to 32 kg/m2, inclusive; * Healthy, as judged by physician from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations; * Agree to use effective contraceptive methods as defined by protocol; * Negative hepatitis panel and HIV scr...
GDC-0032 is an investigational small molecule being studied for the treatment of HER2-negative locally recurrent or metastatic breast cancer and non-small cell lung cancer. It has also been evaluated in healthy volunteers for drug interaction and pharmacokinetic studies. The drug is in Phase 1 clinical development and is not approved for any indication.
GDC-0032 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in cancer patients and healthy volunteers.
GDC-0032 is in Phase 1 clinical development. All clinical trials for this drug have been completed, with no active trials currently ongoing. The drug remains investigational and has not received FDA approval for any use.
GDC-0032 has been studied in three completed Phase 1 trials. NCT01814709 and NCT01967966 evaluated the drug in healthy volunteers, while NCT01862081 assessed it in combination with docetaxel or paclitaxel in patients with HER2-negative breast cancer or non-small cell lung cancer.
GDC-0032 is also known as taselisib. It is a small molecule being developed by Roche for the treatment of certain cancers. The drug has been studied in Phase 1 trials for breast cancer and non-small cell lung cancer, as well as in healthy volunteer studies.