MedTrace Logo

A Study to Evaluate the Effectiveness and Tolerability of a Second Maintenance Treatment in Participants With Ovarian Cancer, Who Have Previously Received Polyadenosine 5'Diphosphoribose [Poly (ADP Ribose)] Polymerase Inhibitor (PARPi) Treatment.

NCT04239014 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-03-10

No results posted yet for this study

Summary

To investigate the effectiveness and tolerability of a second maintenance treatment in participants with platinum-sensitivity relapsed (PSR) epithelial ovarian cancer, who have previously received PARPi maintenance treatment and who have benefit (complete response \[CR\] or partial response \[PR\]) or stable disease (SD) from further platinum based chemotherapy.

Conditions

Interventions

DRUG

Olaparib

Olaparib 300 mg BD (2 × 150 mg tablets) continually in the olaparib monotherapy and ceralasertib+olaparib treatment arms.

DRUG

Ceralasertib

Ceralasertib 160 mg QD (2 × 80 mg tablets) from Days 1 to 7 (inclusive) of every 28-day cycle.

DRUG

Placebo to match olaparib

Per olaparib

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Dr Amit Oza, MD (Lon) FRCP FRCPC · Princess Margaret Cancer Centre, UHN and Mt. Sinai Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-08-07
Primary Completion
2021-01-25
Completion
2021-01-25
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT04239014 on ClinicalTrials.gov