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Neoadjuvant Fulvestrant Plus Abemaciclib in Advanced Low Grade Serous Ovarian Carcinoma
NCT03531645Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Aug 2019
- Primary completion
- Sep 2027
- Countries
- 1
- Sponsor
- University of Texas MD Anderson Cancer Center
- Modality
- Small Molecules
- Conditions
- Low grade serous ovarian cancer (LGSOC)primary peritoneal carcinoma (PPC)fallopian tube carcinoma (PFTC)
01
Overview
Phase 2, open-label, single-arm trial of fulvestrant and abemaciclib in Low grade serous ovarian cancer (LGSOC), primary peritoneal carcinoma (PPC) and fallopian tube carcinoma (PFTC), sponsored by University of Texas MD Anderson Cancer Center. Primary endpoint: Clinical Benefit Rate at 112 days. Started Aug 2019; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Fulvestrant + Abemaciclib
Experimental combination therapy arm
03
Who it enrols
Women >= 18 years with stage III or IV low-grade serous ovarian, primary peritoneal, or fallopian tube carcinomas recommended for neoadjuvant therapy. Must have measurable disease, ECOG PS 0-1, and adequate organ function. Excludes pregnant/breastfeeding women, prior chemo/hormonal therapy for ovarian cancer, known HIV/HBV/HCV, and other recent malignancies.
04
Endpoints
Primary
Clinical Benefit Rate
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