Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GDC-0941 · 11 trials · 8 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. |
| 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. |
| Crossover sequence 1 | EXPERIMENTAL | - |
| Crossover sequence 2 | EXPERIMENTAL | - |
| Crossover sequence 3 | EXPERIMENTAL | - |
| Crossover sequence 4 | EXPERIMENTAL | - |
| A | EXPERIMENTAL | Experimental |
| B | EXPERIMENTAL | - |
| Part 1 | EXPERIMENTAL | - |
| Part 2 | EXPERIMENTAL | - |
| 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 |
| 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. |
| 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. |
| ketoconazole | DRUG | Oral repeating dose |
| rabeprazole | DRUG | Oral repeating dose |
| bevacizumab | DRUG | Bevacizumab 15 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of every 3-week cycle. |
| carboplatin | DRUG | Carboplation IV on Day 1 of every 3-week cycle, at a dose to achieve an area under concentration time curve of 6 milligrams per milliliter\*minute (mg/mL\*min).\\n |
| 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, also known as pictilisib, is an investigational small molecule being studied for use in oncology. It has been evaluated in clinical trials for conditions including HER2-positive metastatic breast cancer, non-Hodgkin's lymphoma, solid cancers, non-squamous non-small cell lung cancer, and breast cancer. It is not approved and remains in clinical development.
GDC-0941 is a small molecule that targets phosphoinositide 3-kinase (PI3K). It is being investigated as a treatment for various cancers, including HER2-positive metastatic breast cancer. The drug is designed to inhibit PI3K, which plays a role in cancer cell growth and survival.
GDC-0941 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is also known as pictilisib. Roche is conducting clinical trials to evaluate its safety and efficacy in oncology indications.
GDC-0941 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The clinical trials for GDC-0941 are completed, with no active trials currently listed.
GDC-0941 has been studied in several completed clinical trials. These include NCT00928330, a Phase 1 study in HER2-positive metastatic breast cancer; NCT01240226, a bioavailability study in healthy volunteers; NCT01474668, an absorption, metabolism, and excretion study; and NCT02092831, a formulation study in healthy volunteers.
Yes, GDC-0941 is also known as pictilisib. The drug is being developed by Roche Holding AG for oncology indications. Clinical trials have used both names to refer to the same investigational small molecule.