A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Sponsor
University Health Network, Toronto
Study ID
NCT02489006
Phase
PHASE2
Status
Unknown

Conditions

  • Debulking Surgical Procedures
  • Fallopian Tube Cancer
  • Neoadjuvant Treatment
  • Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
  • Platinum-based Chemotherapy — DRUG
    Chosen by the study doctor, per standard of care.

Study Details

This is a study that will look at the effects and how useful investigational drug olaparib is as a neoadjuvant treatment (treatment given as to shrink a tumor before the main treatment) prior to surgery in patients with recurrent ovarian, primary peritoneal or fallopian tube cancer.

Key Dates

Start date
Jul 19, 2016
Status verified
Jan 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
71 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib Prior to Surgery, Chemotherapy/Olaparib Post Surgery
    Olaparib, orally, at 300 mg twice per day, for 6 weeks (+/- 2 weeks) prior to surgery. Platinum-based chemotherapy chosen by the study doctor and per standard of care after surgery. Olaparib, orally, at 300 mg twice per day, continuously, after chemotherapy.
  • Experimental: Olaparib Prior to Surgery and Post Surgery
    Olaparib, orally, at 300 mg twice per day, for 6 weeks (+/- 2 weeks) prior to surgery and after surgery.

Primary Outcome Measure

Difference in levels of PAR or PARP-1 before and after study treatment [ Time Frame: 4-8 weeks ]

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