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Cediranib and Olaparib in Combination for Recurrent Ovarian or Triple-Negative Breast Cancer

2014-08-27 03:13:59 | BioPortfolio

Summary

There are two parts to this study. The first part of this research study has the purpose of determining the safety of the combination of the two drugs cediranib and olaparib and the highest doses of these two drugs that can be given in combination to people safely. Cediranib is a drug that may help keep cancer cells from growing by affecting their blood supply. Olaparib is a drug that may stop cancer cells from growing abnormally. These drugs have been used in other research studies in ovarian and breast cancer, and information from those other research studies suggest that these may help to keep cancer from growing in this research study.

Description

Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the study drug. The dose participants will get will depend on the number of participants who have been enrolled in the study before and how well they tolerated their doses.

Each cycle lasts four weeks (28 days), and participants will be taking the study drugs for the entire four weeks. Participants will take cediranib tablets and olaparib capsules orally every day. Cediranib tablets will be taken once in the morning and olaparib capsules will be taken twice a day.

Participants will be asked to monitor their blood pressure on a twice daily basis at home and keep a blood pressure diary. The following tests and procedures will be performed at specific time intervals while the participant is on the study: physical exam, vital signs, blood tests, CT scan/MRI, urine test and ECG.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Ovarian Cancer

Intervention

cediranib, olaparib

Location

University of Chicago Medical Center
Chicago
Illinois
United States
60637

Status

Recruiting

Source

Dana-Farber Cancer Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:59-0400

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Medical and Biotech [MESH] Definitions

Autosomal dominant HEREDITARY CANCER SYNDROME in which a mutation most often in either BRCA1 or BRCA2 is associated with a significantly increased risk for breast and ovarian cancers.

An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.

Cessation of ovarian function after MENARCHE but before the age of 40, without or with OVARIAN FOLLICLE depletion. It is characterized by the presence of OLIGOMENORRHEA or AMENORRHEA, elevated GONADOTROPINS, and low ESTRADIOL levels. It is a state of female HYPERGONADOTROPIC HYPOGONADISM. Etiologies include genetic defects, autoimmune processes, chemotherapy, radiation, and infections.

Cessation of ovarian function after MENARCHE but before the age of 40, without or with OVARIAN FOLLICLE depletion. It is characterized by the presence of OLIGOMENORRHEA or AMENORRHEA, elevated GONADOTROPINS, and low ESTRADIOL levels. It is a state of female HYPERGONADOTROPIC HYPOGONADISM. Etiologies include genetic defects, autoimmune processes, chemotherapy, radiation, and infections.

A homolog of p53 TUMOR SUPPRESSOR PROTEIN that encodes full-length trans-activating and N-terminally-truncated (DeltaN) isoforms. Detection of splice variants and isoforms in the nervous system (human TELENCEPHALON, CHOROID PLEXUS; CEREBROSPINAL FLUID), embryonic tissue, human BREAST CANCER; OVARIAN CANCER, suggest roles in cellular differentiation.

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