Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RO7056119
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...
Top 20 of 87 competitors
GDC-0927 is an investigational small molecule being studied for the treatment of locally advanced or metastatic estrogen receptor positive breast cancer in postmenopausal women. It is being developed by Roche Holding AG and remains in clinical development rather than approved for commercial use.
GDC-0927 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. The company sponsored the Phase 1 clinical study evaluating the compound in postmenopausal women with locally advanced or metastatic estrogen receptor positive breast cancer.
GDC-0927 is in Phase 1 clinical development. The single registered trial, NCT02316509, has completed, and no active trials are currently listed. As a Phase 1 asset, GDC-0927 is investigational and has not been approved by the FDA for any indication.
GDC-0927 has been evaluated in one clinical trial, NCT02316509, titled A Study of GDC-0927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer. The Phase 1 trial enrolled 43 participants across the United States and Spain and is now completed.
The Phase 1 trial NCT02316509 was a controlled, randomized study that enrolled 43 postmenopausal women aged 18 years and older with locally advanced or metastatic estrogen receptor positive breast cancer. It was not double blinded, did not include healthy volunteers, and used biomarker-based patient selection.