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Anti-diabetic
Metformin Hydrochloride for Uterine Cancer
Phase 2
Waitlist Available
Led By Jennifer Johnson, MD, PhD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
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 up to 12 months post last dose of metformin and doxycycline
Awards & highlights
No Placebo-Only Group
Summary
This trialstudies if metformin+doxycycline can help treat localized breast/uterine cancer & reduce toxic side effects of anti-cancer therapy.
Eligible Conditions
- Uterine Cancer
- Breast Cancer
- Endometrial Cancer
- Uterine Carcinosarcoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months post last dose of metformin and doxycycline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post last dose of metformin and doxycycline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the percent of stromal cells expressing Caveolin-1 (CAV1) at an intensity of 1+ or greater assessed by immunohistochemistry
Secondary study objectives
Change in the percent of stromal cells expressing express Monocarboxylate Transporter 4 (MCT4) in the cancer cells
Change in the percent of tumor cells that express Monocarboxylate Transporter 1 (MCT1) and Transporter of Outer Mitochondrial Membrane 20 (TOMM20) in the cancer cells
Objective response rate
+4 moreSide effects data
From 2023 Phase 2 trial • 40 Patients • NCT0373313235%
Diarrhea
10%
Anemia
10%
Nausea
10%
Gastroesophageal reflux disease
5%
Hepatobiliary disorders
5%
Fall
5%
Weight loss
5%
COVID-19 Infection
5%
Flatulence
5%
Pain
5%
Social circumstances
5%
Vomiting
5%
Headache
5%
Stroke
5%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Metformin
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (metformin hydrochloride, doxycycline)Experimental Treatment2 Interventions
Patients receive metformin hydrochloride orally daily on days 1-3 and twice a day starting on day 4. Patients also receive doxycycline orally every 12 hours starting on day 1. Treatment repeats every 7 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxycycline
2008
Completed Phase 4
~2650
Metformin Hydrochloride
2016
Completed Phase 4
~1990
Find a Location
Who is running the clinical trial?
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
163 Previous Clinical Trials
10,993 Total Patients Enrolled
Jennifer Johnson, MD, PhDPrincipal InvestigatorThomas Jefferson University
5 Previous Clinical Trials
100,106 Total Patients Enrolled
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