Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GDC-0980 · 10 trials · 6 indications
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| Everolimus | ACTIVE_COMPARATOR | Participants will receive everolimus (10 mg) orally daily until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination. |
| GDC-0980 | EXPERIMENTAL | Participants will receive GDC-0980 (40 mg) orally daily until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination. |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| Part 1 | EXPERIMENTAL | - |
| Part 2 | EXPERIMENTAL | - |
| Part 3: Group A | EXPERIMENTAL | - |
| Part 3: Group B | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GDC-0980 | DRUG | Oral daily dose |
| Everolimus | DRUG | Everolimus will be administered orally at a 10 mg daily dose. |
| [14C]-GDC-0980 | DRUG | 100 uCi of \[14C\]-GDC-0980 in total dose of 10 mg GDC-0980 |
| Ketoconazole | DRUG | Repeating Oral Dose |
| bevacizumab | DRUG | Intravenous repeating dose |
| carboplatin | DRUG | Intravenous repeating dose |
| cisplatin | DRUG | intravenous repeating dose |
| paclitaxel | DRUG | Intravenous repeating dose |
| pemetrexed | DRUG | intravenous repeating dose |
| capecitabine | DRUG | Oral repeating dose |
| mFOLFOX6 | DRUG | Intravenous repeating dose |
| rabeprazole | DRUG | Oral repeating dose |
Inclusion Criteria: * Patients must have recurrent or persistent endometrial carcinoma that is refractory to curative therapy or established treatments * Histologic confirmation of the original primary tumor is required * Histologic or cytologic confirmation of the recurrent/progressive disease is ...
GDC-0980 is an investigational small molecule being studied for the treatment of solid cancers, renal cell carcinoma, breast cancer, endometrial carcinoma, and non-Hodgkin's lymphoma. It has been evaluated in clinical trials involving patients with advanced solid tumors and metastatic renal cell carcinoma, as well as in healthy volunteers for pharmacokinetic studies.
GDC-0980 is a small molecule that targets the PI3K and mTOR pathways, which are involved in cell growth and survival. By inhibiting these pathways, GDC-0980 aims to reduce tumor cell proliferation. This mechanism is being explored in oncology clinical trials for various solid tumors and renal cell carcinoma.
GDC-0980 is being developed by Roche Holding AG, a multinational healthcare company. Roche is conducting clinical trials to evaluate the safety and efficacy of GDC-0980 in patients with solid cancers and renal cell carcinoma. The company is also investigating the drug in combination with other anticancer agents.
GDC-0980 has completed Phase 1 and Phase 2 clinical trials. The Phase 2 trial evaluated GDC-0980 versus everolimus in patients with metastatic renal cell carcinoma who had progressed on VEGF-targeted therapy. All trials are completed, and GDC-0980 is not approved by the FDA.
GDC-0980 has been studied in three completed clinical trials: NCT01301716, a Phase 1 study combining GDC-0980 with paclitaxel and carboplatin or pemetrexed and cisplatin in solid tumors; NCT01332604, a Phase 1 study with fluoropyrimidine, oxaliplatin, and bevacizumab in advanced solid tumors; and NCT01442090, a Phase 2 study versus everolimus in renal cell carcinoma.
GDC-0980 is also known by the code name RG7422. It is an investigational drug and is not the same as any approved medication. It is being studied for its potential role in treating various cancers, including solid tumors and renal cell carcinoma.