A Study of Cediranib and Olaparib at the Time Ovarian Cancer Worsens on Olaparib
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|ClinicalTrials.gov Identifier: NCT02340611|
Recruitment Status : Completed
First Posted : January 16, 2015
Last Update Posted : June 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Olaparib Drug: Cediranib||Phase 2|
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 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 though 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Proof of Concept Clinical Trial of the Combination Cediranib-Olaparib at the Time of Disease Progression on Olaparib in Ovarian Cancer|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
Experimental: Cediranib and Olaparib
Cediranib, 20 mg , orally, once a day, every day. Olaparib, 150 mg or 200 mg (depending on previous treatment dose), orally, once a day, every day.
Polyadenosine 5'diphosphoribose polymerase (PARP) Inhibitor
Vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor that is a potent inhibitor of all three VEGF receptors (VEGFR-1, -2 and -3)
- Percentage of patients whose cancer shrinks or disappears after treatment [ Time Frame: 2 years ]
- Percentage of decrease in CA-125 levels after treatment [ Time Frame: 2 years ]
- Mutation status of genes compared to response to treatment [ Time Frame: 2 years ]
- Number of occurences per side effect and severity [ Time Frame: 2 years ]
- Assess patient reported outcomes during treatment [ 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): NCT02340611
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Amit Oza, M.D.||Princess Margaret Cancer Centre|