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AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer

NCT01445418 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2019-10-22

No results posted yet for this study

Summary

Background:

* 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.

Objectives:

* 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.

Eligibility:

-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.

Design:

* 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.

Conditions

Interventions

DRUG

AZ2281 + Carboplatin

Cohort 1: Dose escalation: AZD2281 po bid qd + IV carboplatin D8 of each 21-day cycle.; Cohort 2: Expanded cohort treated at the MTD of the combination identified in Cohort 1.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Jung-Min Lee, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-12
Primary Completion
2014-09-02
Completion
2019-10-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01445418 on ClinicalTrials.gov