NCT02822157

Brief Summary

This is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard chemotherapy with the possibility of crossover at the time of progression.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

4.9 years

First QC Date

June 6, 2016

Last Update Submit

January 26, 2021

Conditions

Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Objective Response

    1 year after end inclusion

Study Arms (2)

Olaparib

EXPERIMENTAL

olaparib 300mg oral tablets twice daily for 28 days in 28-day cycles

Drug: Olaparib

Chemotherapy

ACTIVE COMPARATOR

physician's choice chemotherapy

Drug: carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly

Interventions

OlaparibDRUG
Also known as: Lynparza
Olaparib
carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weeklyDRUG

physician's choice chemotherapy

Chemotherapy

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • with recurrent epithelial carcinoma of the ovary, fallopian tube or primary peritoneum
  • At least 1 previous line of chemotherapy
  • Measurable disease
  • Patients have a normal organ and bone marrow function measured within 28 days of randomization
  • WHO 0-2

You may not qualify if:

  • Primary platinum-refractory disease
  • Known hypersensitivity to olaparib
  • Resting ECG with QTc \> 470 msec
  • Concomitant use of known potent CYP3A4 inhibitors
  • Symptomatic uncontrolled brain metastases
  • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, Belgium

Location

Related Publications (1)

  • Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.

    PMID: 35170751DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

olaparibCarboplatinGemcitabinePaclitaxelliposomal doxorubicinTopotecan

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesCamptothecinAlkaloids

Study Officials

  • Ignace Vergote

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2016

First Posted

July 4, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2021

Study Completion

July 1, 2023

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

BE(1)