Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GDC-0032 Tablet, Taselisib
GDC-0032 · 3 trials · 4 indications
Objective response rate (ORR) was defined as proportion of participants achieving complete response (CR) or partial response (PR). As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).
| Arm | Type | Description |
|---|---|---|
| Letrozole + Placebo | PLACEBO_COMPARATOR | Participants will receive 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks. |
| Letrozole + Taselisib | EXPERIMENTAL | Participants will receive 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks. |
| Arm A | EXPERIMENTAL | Arm A \- Taselisib with Trastuzumab emtansine (also called T-DM1) * Taselisib administered orally, daily in each treatment cycle (3 weeks). * Trastuzumab emtansine (also called T-DM1) administered once via IV per treatment cycle (3 weeks). |
| Arm B | EXPERIMENTAL | Arm B -Taselisib with T-DM1 and Pertuzumab * Taselisib is administered oral, daily or every other day per treatment cycle (3 weeks). * Trastuzumab emtansine (also called T-DM1) administered once via IV per treatment cycle (3 weeks). * Pertuzumab- administered once via IV per treatment cycle (3 weeks). |
| Arm C | EXPERIMENTAL | Arm C: * Taselisib with Pertuzumab and Trastuzumab * Cohort C will not open without additional authorization from Genentech * Taselisib is administered oral, daily in each treatment cycle (3 weeks). * Trastuzumab administered once via IV per treatment cycle (3 weeks). * Pertuzumab- administered once via IV per treatment cycle (3 weeks). |
| Arm D | EXPERIMENTAL | Arm D * Taselisib with Pertuzumab, Trastuzumab, and Paclitaxel * Cohort will not be opened without additional authorization from Genentech * Taselisib- administered oral, daily in each treatment cycle (3 weeks). * Pertuzumab- administered once via IV per treatment cycle (3 weeks). * Trastuzumab administered once via IV per treatment cycle (3 weeks). * Paclitaxel- administered via IV, weekly for 3 weeks within each cycle. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Letrozole | DRUG | Letrozole tablets will be administered orally at 2.5 mg QD for 16 weeks. |
| Placebo | OTHER | Placebo tablets matched to taselisib formulation will be administered orally daily on 5 days-on/2 days-off schedule for up to 16 weeks. |
| Taselisib | DRUG | Taselisib will be administered orally at 4 mg (two 2 mg tablets) daily. |
| Trastuzumab emtansine | DRUG | - |
| Pertuzumab | DRUG | - |
| Trastuzumab | DRUG | - |
| Paclitaxel | DRUG | - |
| 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. |
| GDC-0032 | DRUG | Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets. |
Inclusion Criteria: * Female participants * Postmenopausal status * Histologically confirmed invasive breast carcinoma, with all of the following characteristics: (i) Primary tumor greater than or equal to (\>/=) 2 centimeters (cm) in largest diameter (cT1-3) by MRI; (ii) Stage I to operable Stage ...
GDC-0032 is an investigational small molecule oncology drug being developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial in patients with HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer. It is not described as approved and remains in clinical development.
GDC-0032 has been studied for treatment in adults with HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer. The Phase 1 trial enrolled 80 patients across the United States, Belgium, Canada, and Spain. It is investigational and has not been established as an approved therapy for these cancers.
GDC-0032 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the Phase 1 dose-escalation study of GDC-0032 given in combination with docetaxel or with paclitaxel in patients with HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer.
GDC-0032 is in Phase 1 development. Its single recorded trial, NCT01862081, was a Phase 1 dose-escalation study that has been completed. The study enrolled 80 patients and evaluated GDC-0032 in combination with docetaxel or with paclitaxel. GDC-0032 is investigational and not described as FDA approved.
GDC-0032 has been evaluated in one clinical trial, NCT01862081, titled a dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0032 in combination with docetaxel or with paclitaxel. That Phase 1 trial is completed and enrolled 80 patients with HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer.
Yes, GDC-0032 Tablet is an alternative name for GDC-0032, the investigational small molecule developed by Roche Holding AG. Both names refer to the same agent studied in the completed Phase 1 trial NCT01862081 in HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer.