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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborators: |
Massachusetts General Hospital Beth Israel Deaconess Medical Center University of Chicago National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | Joyce Liu, MD, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01116648 |
Purpose
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. This study is now entering the second part of the study, where we are comparing the effects of the combination of olaparib and cediranib to that of olaparib only in women with certain types of recurrent ovarian, fallopian tube, or primary peritoneal cancers.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer |
Drug: cediranib Drug: olaparib |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of Cediranib and Olaparib in Combination for Treatment of Recurrent Papillary-Serous Ovarian, Fallopian Tube or Peritoneal Cancer or for Treatment of Recurrent Triple-Negative Breast Cancer |
| Estimated Enrollment: | 90 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Phase 1: Cediranib and olaparib (complete)
Phase I dose escalation of cediranib and olaparib in combination.
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Drug: cediranib
Tablets taken orally once in the morning
Other Name: AZD2171
Drug: olaparib
Capsules taken orally twice a day
Other Name: AZD2281
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Experimental: Phase 2: Cediranib and olaparib
Cediranib 30mg daily and olaparib 200mg twice daily.
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Drug: cediranib
Tablets taken orally once in the morning
Other Name: AZD2171
Drug: olaparib
Capsules taken orally twice a day
Other Name: AZD2281
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Active Comparator: Phase 2: Olaparib
Olaparib 400mg BID
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Drug: olaparib
Capsules taken orally twice a day
Other Name: AZD2281
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In the first part of the study, since we were looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects, not everyone who participated in this part of the research study received the same dose of the study drug. This portion of the study has now completed.
In the second portion of the study, participants will be randomized to receive either the combination of cediranib and olaparib or to receive olaparib alone. Participants will know which arm they have been randomized to, but do not have any control over which arm it will be.
Each cycle lasts four weeks (28 days), and participants will be taking the study drugs for the entire four weeks. Participants will take drugs orally as specified in the given treatment arm. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria (Phase I):
Additional inclusion criteria (Phase II only):
Exclusion Criteria:
Contacts and Locations| Contact: Joyce Liu, MD | 617-632-5269 | |
| Contact: Christine Lundquist | 617-632-5839 | clundquist@partners.org |
| United States, Illinois | |
| University of Chicago Medical Center | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: Gini F Fleming, MD | |
| United States, Indiana | |
| Fort Wayne Oncology/Hematology | Active, not recruiting |
| Fort Wayne, Indiana, United States, 46845 | |
| United States, Maryland | |
| National Cancer Institute | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: Nicole Houston, RN 301-443-6431 houstonnd@mail.nih.gov | |
| Principal Investigator: Elise Kohn, MD | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Christin Whalen, RN christin_whalen@dfci.harvard.edu | |
| Contact: Lauren Pereira lauren_pereira@dfci.harvard.edu | |
| Principal Investigator: Joyce Liu, MD | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: Michael Birrer, MD, PhD | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Mary Buss, MD, MPH | |
| Principal Investigator: | Joyce Liu, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Joyce Liu, MD, Medical Oncologist, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01116648 History of Changes |
| Obsolete Identifiers: | NCT01115829 |
| Other Study ID Numbers: | DFCI 09-293, U01CA062490-16S2, NCI 8348 |
| Study First Received: | April 29, 2010 |
| Last Updated: | April 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
cediranib olaparib |
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Breast Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases |