A Phase I/IB Study fo AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies
- We are looking for the highest dose of the study drugs that can be administered safely
without severe or unmanageable side effects in participants that have recurrent
gynecological cancers. Not everyone who participates in this research study will
receive the same dose of the study drug.
- There will be samples of blood taken that measure any additional effect of the study
drugs and to look for a marker for the participant's particular type of cancer. Blood
will be taken at a certain point in the study to evaluate the interaction of the two
study drugs, cediranib and temsirolimus when given together. These are called
pharmacokinetic (PK) samples. About 6 teaspoons of blood will be taken with each PK
sample with a total of 34 samples taken.
- Participants will be given a study medication diary for each treatment cycle. Each
cycle lasts four weeks (28 days). Temsirolimus will be given on days 1, 8, 15 and 22
of each cycle. Cediranib wil be taken orally once daily in the morning.
- Participants will be asked to monitor their blood pressure on a daily basis at home and
keep a blood pressure diary.
- The following tests and procedures will be performed at specific time periods during
the course of the study: medical history; side effect assessment; physical exam; vital
signs; blood tests; CT scan; MUGA or ECHO; EKG and urine test.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose of cediranib with temsirolimus in patients with recurrent/refractory gynecological malignancies.
1 year
Yes
Susana Campos, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Food and Drug Administration
09-397
NCT01065662
February 2010
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |