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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02822157
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Ovarian Epithelial Cancer Drug: Olaparib Drug: carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian
Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Olaparib

Arm Intervention/treatment
Experimental: Olaparib
olaparib 300mg oral tablets twice daily for 28 days in 28-day cycles
Drug: Olaparib
Other Name: Lynparza

Active Comparator: Chemotherapy
physician's choice chemotherapy
Drug: carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly
physician's choice chemotherapy




Primary Outcome Measures :
  1. Overall Objective Response [ Time Frame: 1 year after end inclusion ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822157


Contacts
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Contact: Joke De Roover +32 16 34 74 19 joke.deroover@uzleuven.be

Locations
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Belgium
UZLeuven Recruiting
Leuven, Belgium
Contact: Ignace Vergote    +32 16 34 74 19    joke.deroover@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
AstraZeneca
Investigators
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Principal Investigator: Ignace Vergote Universitaire Ziekenhuizen Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02822157    
Other Study ID Numbers: CLIO
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Carcinoma, Ovarian Epithelial
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Gemcitabine
Paclitaxel
Carboplatin
Doxorubicin
Liposomal doxorubicin
Topotecan
Olaparib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites