MedTrace Logo

Olaparib Tablets Maintenance Monotherapy Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

NCT03534453 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 229

Last updated 2025-07-10

No results posted yet for this study

Summary

This is a prospective, open-label, single arm, multi-centre interventional study to assess the clinical efficacy and safety of olaparib maintenance monotherapy and will be conducted in patients with platinum sensitive relapsed (PSR) high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy

Conditions

  • Relapsed Ovarian Cancer
  • Following Complete or Partial Response to Platinum Based Chemotherapy
  • Platinum Sensitive

Interventions

DRUG

Olaparib 300mg tablets

300mg Olaparib tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.

Sponsors & Collaborators

Principal Investigators

  • Ding MA, PhD · Tongji Hospital, Tongji Medical College of Huazhong University of Sicence and Technology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2025-01-27
Completion
2025-01-27

Countries

  • China
  • Malaysia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03534453 on ClinicalTrials.gov