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

NCT00753740 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-06-12

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

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.

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.

DRUG

5% Dextrose (Placebo)

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

Sponsors & Collaborators

  • NewLink Genetics Corporation

    lead INDUSTRY

Principal Investigators

  • Jonathan S Berek, MD, MMS · Professor and Chair, Department of Obstetrics and Gynecology Stanford University School of Medicine Stanford Cancer Center

  • Franco Muggia, MD · 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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
78 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-10-31
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00753740 on ClinicalTrials.gov