Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy
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|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.
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): NCT01442870
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Wasif Saif, MD||Tufts Medical Center|