Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy
|ClinicalTrials.gov Identifier: NCT01442870|
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Metformin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||November 2014|
No Intervention: No metformin
No metformin during primary endpoint assessment period (at least 3 weeks). Patients will subsequently be initiated on metformin.
- Incidence of dose limiting toxicity when metformin is added to chemotherapy [ Time Frame: 1 cycle (at least 3 weeks) ]The primary endpoint of the study will be to determine whether metformin can be safely added to a chemotherapy regimen that is previously well tolerated. The rate of dose limiting toxicities will be compared.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 cycle (at least 3 weeks) ]Secondary endpoints will include assessment of AEs ≥ grade 3 and Serious Adverse Events (SAEs), assessment of safety beyond the first cycle with metformin, and an exploration of metformin-chemotherapy drug interactions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442870
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Wasif Saif, MD||Tufts Medical Center|