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Also known as PI3-Kinase Inhibitor, Pictilisib
GDC-0941 · 8 trials · 7 indications
| Arm | Type | Description |
|---|---|---|
| A: Paclitaxel, GDC-0941 | EXPERIMENTAL | Participants will receive GDC-091 260 milligrams (mg) orally in repeated rounds of once daily (QD) dosing for 5 consecutive days followed by 2 consecutive days during which GDC-0941 will not be administered (5/7-day schedule). This 5/7-day schedule will be repeated weekly in each 28-day cycle until disease progression or intolerable toxicity. Participants will receive 90 milligrams per square meter (mg/m\^2) intravenously (IV) weekly for 3 out of 4 weeks in every 28-day cycle. |
| B: Paclitaxel, Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching to GDC-0941 on the 5/7-day schedule along with 90 mg/m\^2 IV weekly for 3 out of 4 weeks in every 28-day cycle. |
| Arm A: 340 mg pictilisib + CP | EXPERIMENTAL | Participants with advanced (Stage IV) or recurrent squamous NSCLC will be administered 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P). |
| Arm B: Placebo + CP | PLACEBO_COMPARATOR | Participants with advanced (Stage IV) or recurrent squamous NSCLC will be administered placebo corresponding to 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P). Participants with investigator assessed radiographic progression of NSCLC per RECIST 1.1 will be allowed to cross over to Arm A during the first 4 cycles with carboplatin + paclitaxel or after chemotherapy has been completed (Cycle \>/= 5). |
| Arm C: 340 mg pictilisib + CPB | EXPERIMENTAL | Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P) plus bevacizumab (B). |
| Arm D: Placebo + CPB | PLACEBO_COMPARATOR | Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered placebo corresponding to 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P). Participants with investigator assessed radiographic progression of NSCLC per RECIST 1.1 will be allowed to cross over to Arm C during the first 4 cycles with carboplatin + paclitaxel + bevacizumab or after chemotherapy has been completed (Cycle \>/= 5). |
| Arm E: 260 mg pictilisib + CPB | EXPERIMENTAL | Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered 260 mg pictilisib plus carboplatin (C) plus paclitaxel (P) plus bevacizumab (B). |
| Arm F: Placebo + CPB | PLACEBO_COMPARATOR | Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered placebo corresponding to 260 mg pictilisib plus carboplatin (C) plus paclitaxel (P). Participants with investigator assessed radiographic progression of NSCLC per RECIST 1.1 will be allowed to cross over to Arm E during the first 4 cycles with carboplatin + paclitaxel + bevacizumab or after chemotherapy has been completed (Cycle \>/= 5). |
| GDC-0941 Matching Placebo + Fulvestrant (Arm E) | PLACEBO_COMPARATOR | Participants with PIK3CA mutation will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle and GDC-0941 matching placebo QD orally starting on Day 1 of Cycle 1, each cycle of 28 days. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination. |
| GDC-0941-260 mg + Fulvestrant (Arm D) | EXPERIMENTAL | Participants with PIK3CA mutation will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle and GDC-0941 260 mg QD orally starting on Day 1 of Cycle 1, each cycle of 28 days. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination. |
| GDC-0941-340 mg + Fulvestrant (Arm A) | EXPERIMENTAL | Participants will receive fulvestrant 500 milligrams (mg) as 2 intramuscular (IM) injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle and GDC-0941 340 mg once daily (QD) orally starting on Day 15 of Cycle 1, each cycle of 28 days. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination. |
| GDC-0948 or GDC-0980 Matching Placebo + Fulvestrant (Arm C) | PLACEBO_COMPARATOR | Participants will be randomized in 1:1 ratio to receive GDC-0948 matching placebo or GDC-0980 matching placebo with fulvestrant. Participants will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle and GDC-0948 or GDC-0980 matching placebo QD orally starting on Day 15 of Cycle 1, each cycle of 28 days. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination. |
| GDC-0980-30 mg + Fulvestrant (Arm B) | EXPERIMENTAL | Participants will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle and GDC-0980 30 mg QD orally starting on Day 15 of Cycle 1, each cycle of 28 days. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination. |
| GDC-0941+Paclitaxel+Carboplatin | EXPERIMENTAL | Bevacizumab-ineligible non-small cell lung cancer (NSCLC) participants may receive up to 6 cycles (21-day cycle) of combination chemotherapy with paclitaxel and carboplatin along with GDC-0941 |
| GDC-0941+Paclitaxel+Carboplatin+Bevacizumab | EXPERIMENTAL | Bevacizumab-eligible NSCLC particpants may receive up to 6 cycles of combination chemotherapy with paclitaxel and carboplatin along with GDC-0941 and bevacizumab. |
| GDC-0941+Pemetrexed+Cisplatin | EXPERIMENTAL | Bevacizumab-ineligible NSCLC participants may receive up to 6 cycles of combination chemotherapy with pemetrexed and cisplatin along with GDC-0941.\\n |
| GDC-0941+Pemetrexed+Cisplatin+Bevacizumab | EXPERIMENTAL | Bevacizumab-eligible NSCLC participants may receive up to 6 cycles of combination chemotherapy with pemetrexed and cisplatin along with GDC-0941 and bevacizumab.\\n |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| Group A: GDC-0941 QD Dose Escalation | EXPERIMENTAL | Participants will receive GDC-0941 for up to 1 year, administered orally QD at a starting dose of 15 milligrams (mg). |
| Group B: GDC-0941 BID Dose Escalation | EXPERIMENTAL | Participants will receive GDC-0941 for up to 1 year, administered orally BID at a starting dose determined from Group A assessments. |
| Group C: GDC-0941 QD or BID Expansion | EXPERIMENTAL | Participants will receive GDC-0941 for up to 1 year, administered orally QD or BID. The dose/regimen will be determined on the basis of data from Groups A and B. |
| Name | Type | Description |
|---|---|---|
| GDC-0941 | DRUG | GDC-0941 will be administered QD orally for 5 consecutive days each week. |
| Placebo | DRUG | Placebo matching to GDC-0941 |
| Paclitaxel | DRUG | Paclitaxel will be administered IV weekly for 3 out of 4 weeks in every 28-day cycle. |
| pictilisib | DRUG | Pictilisib, 260 milligrams (mg) or 340 mg, will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, pictilisib will be taken once daily continuously. |
| bevacizumab | DRUG | Bevacizumab, 15 milligrams per kilogram (mg/kg) will be administered intravenously (IV) at Day 1 of each 21-day cycle for a maximum of 34 cycles. |
| carboplatin | DRUG | Carboplatin will be administered IV to achieve an initial target area under the concentration curve (AUC) of 6 milligrams per milliliter per minute (mg/mL per min) on Day 1 of each 21-day cycle for a maximum of four cycles. |
| Fulvestrant | DRUG | Participants will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle, each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination. |
| GDC-0941 Matching Placebo | DRUG | Participants will receive GDC-0941 matching placebo QD orally from Day 1 or Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination. |
| GDC-0980 | DRUG | Participants will receive GDC-0980 30 mg (Part I) QD orally from Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination. |
| GDC-0980 Matching Placebo | DRUG | Participants will receive GDC-0980 matching placebo QD orally from Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination. |
| cisplatin | DRUG | Cisplatin 75 milligrams per square meter (mg/m\^2) IV on Day 1 of every 3-week cycle.\\n |
| pemetrexed | DRUG | Pemetrexed 500 mg/m\^2 IV on Day 1 of every 3-week cycle. |
| erlotinib HCl | DRUG | Oral repeating dose |
| Trastuzumab | DRUG | Intravenous repeating dose |
| trastuzumab-MCC-DM1 | DRUG | Intravenous repeating dose |
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease * Human epidermal growth factor receptor 2 (HER2)-negative and hormone receptor (HR) (estrogen receptor and/or progesterone recepto...
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GDC-0941 is an investigational small molecule being studied in oncology for breast cancer, including locally recurrent and metastatic breast cancer, as well as non-Hodgkin's lymphoma, solid cancers, and non-squamous non-small cell lung cancer. It is not approved for any indication and remains in clinical development.
GDC-0941 is a PI3-kinase inhibitor. It targets phosphoinositide 3-kinase (PI3K), a lipid kinase involved in cell growth and survival signaling. By inhibiting PI3K, GDC-0941 is designed to interfere with signaling pathways that drive tumor cell proliferation and survival.
GDC-0941 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical trials evaluating GDC-0941 in breast cancer, non-small cell lung cancer, and other solid tumors.
GDC-0941 is in Phase 2 clinical development. Two Phase 2 trials have been completed, and additional Phase 1 trials have also been completed. The drug is investigational and has not been approved by the FDA for any indication.
GDC-0941 has been evaluated in completed trials including NCT01740336, a Phase 2 study of paclitaxel with GDC-0941 versus paclitaxel with placebo in locally recurrent or metastatic breast cancer, and NCT01437566, a Phase 2 study of GDC-0941 or GDC-0980 with fulvestrant in advanced or metastatic breast cancer resistant to aromatase inhibitor therapy. Phase 1 trials include NCT00975182 and NCT00974584.