Efficacy Study of Maintenance IT-101 Therapy for Ovarian Cancer Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-05-31

Brief Summary

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This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer.

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Detailed Description

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Conditions

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Cancer Ovarian Cancer Solid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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12mg/m2/dose

12mg per meter squared per dose

Group Type EXPERIMENTAL

IT-101 (12mg/m2/dose)

Intervention Type DRUG

Patients who satisfy the inclusion/exclusion criteria will receive a blinded infusion of IT-101 (12mg/m2/dose) every other week until disease progression.

15mg/m2/dose

15mg per meter squared per dose

Group Type EXPERIMENTAL

IT-101 (15mg/m2/dose)

Intervention Type DRUG

Patients who satisfy the inclusion/exclusion criteria will receive an infusion of IT-101 (15mg/m2) every other week until disease progression.

Placebo

5% dextrose infusion (placebo)

Group Type PLACEBO_COMPARATOR

5% Dextrose (Placebo)

Intervention Type DRUG

Patients who satisfy the inclusion/exclusion criteria will receive an infusion of placebo every other week until disease progression.

Interventions

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IT-101 (12mg/m2/dose)

Patients who satisfy the inclusion/exclusion criteria will receive a blinded infusion of IT-101 (12mg/m2/dose) every other week until disease progression.

Intervention Type DRUG

IT-101 (15mg/m2/dose)

Patients who satisfy the inclusion/exclusion criteria will receive an infusion of IT-101 (15mg/m2) every other week until disease progression.

Intervention Type DRUG

5% Dextrose (Placebo)

Patients who satisfy the inclusion/exclusion criteria will receive an infusion of placebo every other week until disease progression.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women between the age of 18 and 78, inclusive;
* Evidence of platinum-sensitive ovarian cancer following the patient's primary treatment(\>= 6 months);
* Received a 2nd line platinum-based chemotherapy regimen (4-6 cycles) without evidence of progression;
* May have measurable or unmeasurable disease;
* Eastern Cooperative Oncology Group (ECOG) 0 or 1;
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

* Women who are pregnant or lactating;
* Prior treatment with a topoisomerase inhibitor;
* Patients with unacceptable organ and/or hematologic reserve at screening;
* Urine protein of \> 500 mg/day or active nephropathy;
* Electrocardiogram (ECG) with evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator;
* History of pancreatitis within the last 12 months;
* Patients treated with previous high dose chemotherapy or stem cell transplant within the last 5 years;
* Use of any investigational agents within 4 weeks of study enrollment;
* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, psychiatric illness or other co-morbidity that presents a risk to the patient as determined by the investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan S Berek, MD, MMS

Role: PRINCIPAL_INVESTIGATOR

Professor and Chair, Department of Obstetrics and Gynecology Stanford University School of Medicine Stanford Cancer Center

Franco Muggia, MD

Role: PRINCIPAL_INVESTIGATOR

Anne Murnick Cogan and David H. Cogan Professor of Oncology, Director of the Division of Medical Oncology at NYU Medical Center, and Associate Director for Clinical Research