Temsirolimus in Combination With Metformin in Patients With Advanced Cancers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01529593|
Recruitment Status : Active, not recruiting
First Posted : February 9, 2012
Last Update Posted : May 10, 2019
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.
The goal of this clinical research study is to find the highest tolerable dose of the combination of temsirolimus and metformin that can be given to patients with advanced cancer. The safety of the drug combination will also be studied.
Temsirolimus is designed to block a protein called mTOR (a protein that is thought to cause cancer cells to grow) inside the cancer cell. This may interfere with the growth or spread of cancer cells or possibly kill them.
Metformin was designed to treat patients with diabetes. It may be able to block the protein mTOR and slow the growth of tumors.
This is an investigational study. Temsirolimus is FDA approved and commercially available for the treatment of renal cell carcinoma. Metformin is FDA approved and commercially available for the treatment of diabetes mellitus. The combination of these drugs to treat advanced cancer is investigational.
Up to 104 patients will take part in this study. All will be enrolled at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancers||Drug: Temsirolimus Drug: Metformin||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Temsirolimus in Combination With Metformin in Patients With Advanced Cancers|
|Actual Study Start Date :||March 26, 2012|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: Temsirolimus + Metformin
Starting dose of Temsirolimus 25 mg by vein weekly. Metformin titrated over 3 weeks at 500 mg by mouth daily. Four weeks of treatment constitute 1 cycle. Cycle one (1) however, will be 6 weeks long to allow for metformin titration.
Starting dose: 25 mg by vein weekly.
Expansion cohort: Once MTD is determined, or at maximum tolerated dose level explored (Level 5) if MTD is not reached, additional 14 patients enrolled.
Starting dose: 500 mg titrated over first 3 weeks.
Expansion cohort: Once MTD is determined, or at maximum tolerated dose level explored (Level 5) if MTD is not reached, additional 14 patients enrolled
- Maximum Tolerated Dose (MTD) of Temsirolimus and Metformin [ Time Frame: 10 weeks ]MTD defined as highest dose studied in which incidence of dose limiting toxicity (DLT) less than 33%. DLTs defined as adverse events (AEs) related to study agents which occur during first cycle of treatment. Toxicity must have possible, probable or definite attribution to study drugs.
- Clinical Tumor Response [ Time Frame: 10 weeks ]Clinical efficacy measured by objective tumor response per RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Clinical response defined as Complete Response (CR) or Partial Response (PR) or at least 4 months Stable Disease (SD).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529593
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Aung Naing, MD||M.D. Anderson Cancer Center|