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NCT00477386 · ClinicalTrials.gov registry record · Phase 1

Trial of Decitabine as a Sensitizer to Carboplatin in Platinum Resistant Recurrent Ovarian Cancer

A Phase 1 study of Ovarian Cancer, sponsored by Indiana University.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target
1
Study location

NCT00477386 is a Phase 1 study of Ovarian Cancer that has completed, run by Indiana University. The registered enrollment target is 28 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00477386, a Phase 1 study of Ovarian Cancer, has completed, sponsored by Indiana University.

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

Study Summary

Based on these pre-clinical data, which were generated by our group, the investigators propose to test in a phase I/II clinical trial the following hypothesis: demethylation induced by decitabine results in re-sensitization to platinum in recurrent ovarian cancer. To test this hypothesis, the investigators will treat patients with recurrent ovarian cancer platinum resistant (recurrence within 6 months from platinum therapy) or platinum-refractory (no response to platinum) with a combination consisting of decitabine and carboplatin. This will be an institutional open label phase I/II trial to determine the safety and the biologic activity of the Decitabine/Carboplatin combination. The investigators will determine whether Carboplatin can be safely combined with Decitabine, the optimal dose schedule and the investigators will define whether at this dosage, the regimen is biologically active (i.e. induces demethylation of target genes). In the second part of the trial, the investigators will determine the clinical activity of the combination in a population of patients with platinum-resistant ovarian cancer.

Conditions Studied

Ovarian Cancer

Interventions

  • DRUG decitabine

Study Locations (1)

Indiana

  • Indiana University Cancer Center - Indianapolis

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2007-07
Est. Completion 2013-09
Phase Phase 1

Sponsor

Indiana University

890 total trials

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What the Registry Record Tells You About NCT00477386

The ClinicalTrials.gov registry entry for NCT00477386 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.

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

NCT00477386 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.

Frequently Asked Questions

What is clinical trial NCT00477386 about?

NCT00477386 is a clinical study titled "Trial of Decitabine as a Sensitizer to Carboplatin in Platinum Resistant Recurrent Ovarian Cancer". Based on these pre-clinical data, which were generated by our group, the investigators propose to test in a phase I/II clinical trial the following hypothesis: demethylation induced by decitabine results in re-sensitization to platinum in recurrent ovarian cancer. To test this hypothesis, the inves...

What is the current status of trial NCT00477386?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2007-07. Estimated completion is 2013-09.

What conditions does trial NCT00477386 study?

This clinical trial studies the following conditions: Ovarian Cancer.

What interventions are being tested in trial NCT00477386?

The interventions under investigation include: decitabine (DRUG).

Who is sponsoring clinical trial NCT00477386?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00477386 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.