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Amylin Analog

Cohort 1: Pramlintide 60 mcg twice daily for Squamous Cell Carcinoma

Phase < 1
Waitlist Available
Led By Nikhil Khushalani, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
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 at 44 days from on study date
Awards & highlights

Summary

This trial will test pramlintide as a possible treatment for squamous cell carcinoma. Two weeks before surgery, patients will take pramlintide. Tissue from before and after treatment will be compared to see if there are any changes.

Eligible Conditions
  • Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 44 days from on study date
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 44 days from on study date for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Participant Compliance
Secondary study objectives
Number of Adverse Events

Side effects data

From 2022 Phase 4 trial • 22 Patients • NCT01841359
18%
Hypoglycemia
14%
Nausea
5%
Increase in baseline anxiety.
5%
Cold feeling behind eyes.
5%
Trembling
5%
Ethanol abuse / intoxication
5%
Diarrhea (with urgency and incontinence)
5%
Auditory hallucinations
5%
Symptoms of a urinary tract infection (UTI) (CVA tenderness w/ dysuria)
5%
Nightmares
5%
Hyperglycemia
5%
Elevated liver enzymes
5%
Altered taste (during treatment with study drug)
5%
Cholecystitis (prior to treatment with study drug)
5%
Sinus infection (Visit 4, following treatment with study drug)
5%
Weight loss (during study drug treatment)
5%
Dehydration (r/t diarrhea)
5%
Diarrhea (assoc. with dehydration requiring hospitalization)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pramlintide (Symlin)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3: Pramlintide 120 mcg three times dailyExperimental Treatment1 Intervention
Participants will self inject Parmlintide 120 mcg three times daily for two weeks prior to surgical resection of tumor.
Group II: Cohort 2: Pramlintide 60 mcg three times dailyExperimental Treatment1 Intervention
Participants will self inject Parmlintide 60 mcg three times daily for two weeks prior to surgical resection of tumor.
Group III: Cohort 1: Pramlintide 60 mcg twice dailyExperimental Treatment1 Intervention
Participants will self inject Pramlintide 60 mcg twice daily for two weeks prior to surgical resection of tumor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pramlintide
2022
Completed Phase 4
~110

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
558 Previous Clinical Trials
144,540 Total Patients Enrolled
Nikhil Khushalani, MDPrincipal InvestigatorMoffitt Cancer Center
5 Previous Clinical Trials
95 Total Patients Enrolled
~0 spots leftby Sep 2025
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