West Cancer Center

OVARIAN: Metastatic: Plat Sensitive: >2nd Line: \"LIGHT\"

Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects With Different HRD Tumor Status and With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at Least 2 Prior Lines of Chemotherapy

Title

AstraZeneca D0816L00003 Ovarian LIGHT

Study Title

Site Link

NCT02983799

Malignancy

Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

3rd Line or greater

Investigational Agent

Olaparib

Drug Class

PARP inhibitor

Adam ElNaggar, MD

Sponsor

AstraZeneca

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically diagnosed relapsed high-grade serous ovarian cancer (including primary peritoneal and/or fallopian tube)
Must have received at least 2 prior platinum-based lines of chemotherapy for ovarian cancer
Must be partially platinum sensitive (progression 6-12 months after last platinum therapy) or platinum sensitive (progression >12 months after last platinum therapy)
ECOG PS 0-1
Available archived tissue for central testing
No prior PARP inhibitor therapy
No other malignancy within last 5 years
No pneumonitis
No symptomatic uncontrolled brain metastases
No known active HBV or HCV
No immunocompromised subjects

Objective

Primary- ORR: Secondary: DoR, CA-125 RR, PFS, TTP, OS

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

High-grade serous; 3 of 4 cohorts must be BRCAmt or HRD-positive

Dosing Frequency

Control Agents

Study Protocol

Randomized