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GDC-0927 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part I: Dose Escalation - GDC-0927 | EXPERIMENTAL | Participants will receive GDC-0927 orally as a single dose on Day -7. Continuous daily dosing will commence on Day 1. Depending on safety and tolerability, participants will be assigned sequentially to escalating doses of GDC-0927 with use of a standard 3 + 3 design. The starting dose will be 600 milligrams per day (mg/day), followed by dose escalation in 400 milligrams (mg) increments. |
| Part II: Dose Expansion - GDC-0927 | EXPERIMENTAL | Participants in the expansion cohorts will receive GDC-0927 at MTD/RP2D starting from Day 1 of Cycle 1 (cycle length: 28 days) up to disease progression, unacceptable toxicity, participant withdrawal of consent or study termination. |
| Name | Type | Description |
|---|---|---|
| GDC-0927 | DRUG | GDC-0927 will be administered as per schedule specified in the respective arm. |
Inclusion Criteria: * Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease, both progressing after at least 6 months of hormonal t...
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GDC-0927 is an investigational small molecule being studied for the treatment of breast cancer. It is being evaluated in postmenopausal women with locally advanced or metastatic estrogen receptor positive breast cancer. The drug is currently in Phase 1 clinical development.
GDC-0927 targets the estrogen receptor, as it is being studied in estrogen receptor positive breast cancer. The drug is designed to interfere with estrogen receptor signaling, which is a key driver of tumor growth in this type of breast cancer.
GDC-0927 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 and efficacy in patients with breast cancer.
GDC-0927 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is no longer in active clinical trials.
GDC-0927 has been studied in one completed Phase 1 clinical trial, identified as NCT02316509. This trial enrolled 43 postmenopausal women with locally advanced or metastatic estrogen receptor positive breast cancer and was conducted in the United States and Spain.
GDC-0927 is a distinct investigational compound and is not known to be the same as any other marketed drug. It is being developed specifically for estrogen receptor positive breast cancer and is not referred to by any alternative names in the available information.