CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Metformindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02949700
NCT02949700Phase 2Completed
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A Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma

Baylor College of Medicine·interventional·Posted Oct 31, 2016·Updated Jun 29, 2023

In Brief

A Phase 2 clinical trial evaluating Metformin for Head and Neck Squamous Cell Carcinoma. Completed, enrolled 26 participants across 3 sites.

Detailed Summary

The purpose of this research is to see whether metformin can improve the response rate in patients undergoing chemotherapy and radiation for squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx. The purpose of this research is also to see the effects, good and bad, of metformin therapy for this disease. Researchers will also analyze tumor and blood samples from study patients to test and understand the characteristics of tumors which respond to metformin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Squamous Cell Carcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 31, 2016
Enrollment StartJan 26, 2017
Primary CompletionJun 28, 2021
Study CompletionJul 7, 2022
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 9.7 years ago

Interventions

Metformindrug

Metformin will be administered orally twice daily during treatment with chemo-radiation for head and neck squamous cell carcinoma. This will occur 7 to 11 days prior to chemotherapy and radiation.