Status:
Recruiting
Disease Site:
Endometrial
Phase:
Phase III, Phase IV
Official Title:
GOG-3069 Phase 2 Study of Alpelisib + Fulvestrant for PIK3CA-Mutated ER + Endometrioid Endometrial Cancer
NCT ID:
NCT#05754487
Link to Full Details:
Description:
This is a 2 stage multi-center study designed to evaluate the efficacy of the combination of alpelisib and fulvestrant in patients with PIK3CA-mutated ER-positive endometrioid endometrial cancers by estimating the objective response rate (ORR). Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal.
Eligibility:
Female – 18 years and older
Inclusion Criteria:
- Advanced (Stage III/IV), persistent or recurrent; Histologic confirmation of recurrent disease required.
- Endometrioid histology, all grades
- PIK3CA mutation (R88Q, N345K, C420R, E542K, E545X, Q546X, M1043I, H1047X, G1049R)
- ER +
- Measurable disease
- Prior adjuvant chemo for Stage I, II, III is permitted. Prior chemoradiation for a pelvic recurrence is permitted
- Chemo in the setting of Stage IV is allowed but must be without evidence of disease for at least 6 months from the time of chemo completion
- No more than one prior systemic chemo regimen, and no more than one additional systemic therapy is permitted. Hence eligible patients may have 0-2 prior lines of tx.
- Fasting blood glucose ≤140 and HgbA1c ≤6.4%
Exclusion Criteria:
- Clear cell, serous, carcinosarcoma, mixed histology
- DM Type 1 or uncontrolled Type 2 DM