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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborators: |
Massachusetts General Hospital Beth Israel Deaconess Medical Center National Comprehensive Cancer Network Wyeth is now a wholly owned subsidiary of Pfizer AstraZeneca |
| Information provided by: | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01065662 |
Purpose
The purpose of this research study is to determine the safety of the combination of the two drugs cediranib and temsirolimus and the highest doses of these two drugs that can be given in combination to people safely. Cediranib is a drug that may stop blood supply to the tumor and therefore help keep cancer cells from growing. Temsirolimus is a drug that may stop cancer cells from growing. These drugs have been used in other research studies in ovarian and kidney cancer and these studies suggest that these drugs may help to keep cancer from growing in this research study.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer Ovarian Cancer Cervical Cancer Fallopian Cancer Peritoneal Cancer |
Drug: temsirolimus Drug: cediranib |
Phase 1 |
| Study Type: | Interventional |
| 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/IB Study fo AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies |
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2010 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Susana Campos, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Susana M. Campos, MD, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01065662 History of Changes |
| Other Study ID Numbers: | 09-397 |
| Study First Received: | February 8, 2010 |
| Last Updated: | September 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
AZD2171 temsirolimus advanced gynecological malignancies |
|
Neoplasms Endometrial Neoplasms Uterine Cervical Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female Uterine Cervical Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases |
Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Sirolimus Everolimus Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents |