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NCT02949700 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma
A Phase 1 study of Head and Neck Squamous Cell Carcinoma, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 3
- Study locations
NCT02949700: Completed Phase 1 study of Head and Neck Squamous Cell Carcinoma, sponsored by Baylor College of Medicine.
NCT02949700 is a Phase 1 study of Head and Neck Squamous Cell Carcinoma that has completed, run by Baylor College of Medicine. The registered enrollment target is 26 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02949700, a Phase 1 study of Head and Neck Squamous Cell Carcinoma, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Dose limiting toxicities include diarrhea/gastrointestinal disturbance and hypoglycemia requiring dose reduction, and they will be measured for the time frame detailed above. Adverse Events (AE)s will be graded in accordance with the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE) http://ctep.cancer.gov/ reporting/ctc.html. If not described in the NCI-CTCAE, AEs will be graded according to their severity using the following criteria: grade 1 (mild), grade 2 (moderate), grade 3 (s
Conditions Studied
Interventions
- DRUG Metformin
Study Locations (3)
Texas
- Baylor College of Medicine - Houston
- Michael E. DeBakey Veterans Affairs Medical Center - Houston
- Harris Health System - Smith Clinic - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2017-01-26 |
| Est. Completion | 2022-07-07 |
| Phase | Phase 1 |
What the finished NCT02949700 record still lists
NCT02949700 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Metformin is the first listed.
NCT02949700 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02949700 about?
NCT02949700 is a clinical study titled "Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma". 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 metfor...
What is the current status of trial NCT02949700?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2017-01-26. Estimated completion is 2022-07-07.
What conditions does trial NCT02949700 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT02949700?
The interventions under investigation include: Metformin (DRUG).
Who is sponsoring clinical trial NCT02949700?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02949700 being conducted?
This trial has 3 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02949700's enrollment target sits among peer trials
26 94th of 124 higher than 29 of 124 other Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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