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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post last dose of metformin and doxycycline for reporting.

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 more

Side effects data

From 2023 Phase 2 trial • 40 Patients • NCT03733132

35%

Diarrhea

10%

Anemia

10%

Nausea

10%

Gastroesophageal reflux disease

Fall

Hepatobiliary disorders

Weight loss

COVID-19 Infection

Flatulence

Pain

Social circumstances

Vomiting

Headache

Stroke

Hypertension

100%

80%

60%

40%

20%

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