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Single arm, treatment for Head and Neck Squamous Cell Carcinoma

Phase 1 & 2
Waitlist Available
Led By Vlad Sandulache, MD, PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date of study registration to death or up to 2 years following treatment completion, whichever comes first.
Awards & highlights

Study Summary

This study is evaluating 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.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of study registration to death or up to 2 years following treatment completion, whichever comes first.
This trial's timeline: 3 weeks for screening, Varies for treatment, and date of study registration to death or up to 2 years following treatment completion, whichever comes first. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I - Dose-Limiting Toxicity
Response Elements
Secondary outcome measures
Phase II - Overall Survival
Phase II - Progression Free Survival

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm, treatmentExperimental Treatment1 Intervention
Patients in the Phase I trial will be assigned to a single arm, experimental treatment which will test dose escalation for metformin in the context of chemo-radiation, with toxicity as the primary outcome. Patients in the Phase II trial will be assigned to a single arm, experimental treatment consisting of metformin plus chemo-radiation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,226 Total Patients Enrolled
Vlad Sandulache, MD, PhDPrincipal InvestigatorBaylor College of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma
Vlad Sandulache 2017. "Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02949700.
~3 spots leftby Apr 2025
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