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NCT01579812 · ClinicalTrials.gov registry record · Phase 2

Evaluation of Metformin, Targeting Cancer Stem Cells for Prevention of Relapse in Gynecologic Patients

A Phase 2 study of Ovarian, Fallopian Tube, and Primary Peritoneal Cancer, sponsored by University of Michigan Rogel Cancer Center.

Completed
Registry status
Phase 2
Development phase
90
Enrollment target
1
Study location

NCT01579812: Completed Phase 2 study of Ovarian, Fallopian Tube, and Primary Peritoneal Cancer, sponsored by University of Michigan Rogel Cancer Center.

NCT01579812 is a Phase 2 study of Ovarian, Fallopian Tube, and Primary Peritoneal Cancer that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01579812, a Phase 2 study of Ovarian, Fallopian Tube, and Primary Peritoneal Cancer, has completed, sponsored by University of Michigan Rogel Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
90 participants
Enrollment target
1
Study location

Study Summary

The primary objective of this study is to determine if metformin administered in combination with chemotherapy to women with advanced ovarian, primary peritoneal or fallopian tube cancer will improve recurrence-free survival at 18 months compared to controls.

Primary Outcome

Determine the percentage of patients alive without recurrence at 18 months. Investigators will also determine recurrence free survival when patients with persistent disease are excluded. Definition of progression or recurrence and survival will be defined as increasing clinical, radiological or histological evidence of disease since study entry or two serum values of CA-125 greater than or equal to two times the upper limits of normal (ULN) performed at least one week apart, regardless of CT sc

Interventions

  • DRUG Metformin

Study Locations (1)

Michigan

  • University of Michigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2011-10
Est. Completion 2017-07
Phase Phase 2

What the finished NCT01579812 record still lists

NCT01579812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).

The record links to 1 condition, with Ovarian, Fallopian Tube, and Primary Peritoneal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Metformin is the first listed.

NCT01579812 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT01579812 about?

NCT01579812 is a clinical study titled "Evaluation of Metformin, Targeting Cancer Stem Cells for Prevention of Relapse in Gynecologic Patients". The primary objective of this study is to determine if metformin administered in combination with chemotherapy to women with advanced ovarian, primary peritoneal or fallopian tube cancer will improve recurrence-free survival at 18 months compared to controls.

What is the current status of trial NCT01579812?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2011-10. Estimated completion is 2017-07.

What conditions does trial NCT01579812 study?

This clinical trial studies the following conditions: Ovarian, Fallopian Tube, and Primary Peritoneal Cancer.

What interventions are being tested in trial NCT01579812?

The interventions under investigation include: Metformin (DRUG).

Who is sponsoring clinical trial NCT01579812?

This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01579812 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01579812's enrollment target sits among peer trials

90 772nd of 2000 higher than 1,199 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01579812, the US trial registry maintained by the National Library of Medicine. NCT01579812 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.