A Study of Cediranib and Olaparib at Disease Worsening in Ovarian Cancer

Sponsor
University Health Network, Toronto
Study ID
NCT02681237
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cediranib — DRUG
    Small-molecule inhibitor of several tyrosine kinases including VEGFR-1, VEGFR-2, VEGFR-3 and c-kit.
  • Olaparib — DRUG
    Poly (ADP-ribose) polymerase (PARP) inhibitor.

Study Details

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.

Key Dates

Start date
Apr 29, 2016
Status verified
May 2022
Primary completion
Jan 10, 2022
Completion
Mar 25, 2022

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Objective Response Rate [ Time Frame: 8 weeks ]

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