search
Back to results

Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian Cancer (CLIO)

Primary Purpose

Ovarian Epithelial Cancer

Status
Unknown status
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Olaparib
carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Epithelial Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • UZLeuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Olaparib

Chemotherapy

Arm Description

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

physician's choice chemotherapy

Outcomes

Primary Outcome Measures

Overall Objective Response

Secondary Outcome Measures

Full Information

First Posted
June 6, 2016
Last Updated
January 26, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT02822157
Brief Title
Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian Cancer
Acronym
CLIO
Official Title
Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Epithelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olaparib
Arm Type
Experimental
Arm Description
olaparib 300mg oral tablets twice daily for 28 days in 28-day cycles
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
physician's choice chemotherapy
Intervention Type
Drug
Intervention Name(s)
Olaparib
Other Intervention Name(s)
Lynparza
Intervention Type
Drug
Intervention Name(s)
carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly
Intervention Description
physician's choice chemotherapy
Primary Outcome Measure Information:
Title
Overall Objective Response
Time Frame
1 year after end inclusion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ignace Vergote
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZLeuven
City
Leuven
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
35170751
Citation
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.
Results Reference
derived

Learn more about this trial

Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian Cancer

We'll reach out to this number within 24 hrs