AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer
This study is currently recruiting participants.
Verified May 2013 by National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
First received: September 30, 2011
Last updated: May 14, 2013
Last verified: May 2013
- Carboplatin is approved by the Food and Drug Administration to treat cancer.
- AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a protein that is -involved in repairing DNA damage; PARP inhibitors interfere with that process.
- To determine the optimum doses of AZD2281 and carboplatin that can safely be used in patients with breast and ovarian cancer.
- To evaluate the response of the tumor to the drug combination and determine the side effects of the treatment.
-Patients 18 years of age or older with breast or ovarian cancer who have a family history of cancer or who have a BRCA1 or BRCA2 mutation.
- In this dose escalation study, the first small group of patients receives the smallest study doses of AZD2281 and carboplatin. Subsequent groups receive incrementally higher doses of first AZD2281 and then carboplatin as long as the preceding group has not experienced unacceptable side effects. When the highest safe dose is determined, additional patients receive that dose.
- Patients receive treatment in 21-day cycles as follows: AZD2281 by mouth twice a day every day; carboplatin thorough a vein on day 8 of each cycle. Treatment may continue until it is no longer beneficial.
- Evaluations during treatment include the following:
- Physical examination 1 week after starting treatment and then every 3 weeks.
- Blood tests weekly for the first 4 weeks of treatment and then every 3 weeks.
- CT scans or other imaging tests such as ultrasound or MRI every 6 weeks to evaluate the tumor.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study With an Expansion Cohort of the PARP Inhibitor AZD2281 Combined With Carboplatin in BRCA1/2 Familial Breast and Ovarian Cancer and Sporadic Triple Negative Breast and Ovarian Cancer|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
Primary Outcome Measures:
- Determine the safety and toxicity of the combination of AZ2281 (KU-0059436) and carboplatin in BRCA 1/2-associated recurrent breast and ovarian cancer patients
Secondary Outcome Measures:
- Assess clinical activity of the combination; Determine biochemical changes in the poly(ADP-ribose) polymerase (PARP) and H2AX activity in mononuclear cells and in tumor in response to treatment
|Study Start Date:||March 2008|
Intervention Details:Show Detailed Description
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445418
|Contact: Nicole D. Houston, R.N.||(301) firstname.lastname@example.org|
|Contact: Elise C Kohn, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
Sponsors and Collaborators
|Principal Investigator:||Elise C Kohn, M.D.||National Cancer Institute (NCI)|