A Study of Cediranib and Olaparib at Disease Worsening in Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT02681237|
Recruitment Status : Active, not recruiting
First Posted : February 12, 2016
Last Update Posted : May 10, 2019
This is a proof of concept study (a study to initially assess the benefit a new drug indication) of the combination of two investigational drugs cediranib and olaparib in patients with ovarian cancer whose cancer worsened despite previously receiving a poly (ADP-ribose) polymerase (PARP) inhibitor (such as olaparib).
The purpose of this study is to find out whether taking cediranib and olaparib at the same time will be able to stop tumors from growing further or shrink it.
Cediranib works by blocking (inhibiting) several specific proteins in cancer cells called the vascular endothelial growth factor (VEGF) receptors. These proteins are important in the formation of blood vessels to the tumor. It is believed that many tumors survive because the blood vessels on the tumors bring oxygen and nutrients to the cancer cells which enable them to grow. If the formation of the blood vessels is blocked, the tumor cells may die.
Olaparib, works by blocking a protein called poly [adenosine diphosphate-ribose] polymerase (PARP). PARP is an important protein which tries to fix damaged deoxyribonucleic acid (DNA, molecules that contain important instructions for the development of cells). Many cancers are thought to develop from damaged DNA. By blocking PARP from fixing damaged DNA, the tumor cells may die.
Adding cediranib to olaparib, and therefore blocking several different mechanisms for cancer growth, may stop tumor growth.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Cediranib Drug: Olaparib||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Proof of Concept, Multi-centre, Clinical Trial of the Combination Cediranib-Olaparib at the Time of Disease Progression on PARP Inhibitor in Ovarian Cancer|
|Actual Study Start Date :||April 29, 2016|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||October 2021|
Experimental: Cediranib and Olaparib
Cediranib will be given by mouth, at a dose of 20 mg, once a day, everyday.
Olaparib will given by mouth, at a dose of 300 mg, twice a day, every day.
Small-molecule inhibitor of several tyrosine kinases including VEGFR-1, VEGFR-2, VEGFR-3 and c-kit.
Poly (ADP-ribose) polymerase (PARP) inhibitor.
- Objective Response Rate [ Time Frame: 8 weeks ]
- Progression-Free Survival Rate [ Time Frame: 16 weeks ]
- CA125 response rate [ Time Frame: 2 years ]
- Disease control rate [ Time Frame: 2 years ]
- Overall survival rate [ Time Frame: 2 years ]
- Number of Adverse Events Experienced [ Time Frame: 2 years ]
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): NCT02681237
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Amit Oza, M.D.||Princess Margaret Cancer Centre|