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

June 10, 2020 updated by: NewLink Genetics Corporation

A Phase II Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of Maintenance IT-101 in Platinum Sensitive Ovarian Cancer Patients Who Received 4-6 Cycles of a 2nd Line Platinum-Based Regimen Without Disease Progression.

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

Study Overview

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital, Clinical Research Department/ Cancer Care Specialists of Illinois
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center
    • New York
      • Brightwaters, New York, United States, 11718
        • Schwartz Gynecologic Onclology, PLLC
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 97403
        • Chattanooga GYN Oncology
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
    • Virginia
      • Newport News, Virginia, United States, 23601
        • Riverside Gynecology & Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Key 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.

Key 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 12mg/m2/dose
12mg per meter squared per 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.
Experimental: 15mg/m2/dose
15mg per meter squared per dose
Patients who satisfy the inclusion/exclusion criteria will receive an infusion of IT-101 (15mg/m2) every other week until disease progression.
Placebo Comparator: Placebo
5% dextrose infusion (placebo)
Patients who satisfy the inclusion/exclusion criteria will receive an infusion of placebo every other week until disease progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To Compare the proportion of patients without evidence of disease progression at 30 weeks following randomization between IT-101 at 12 mg/m2/dose or 15 mg/m2/dose to a placebo infusion treatment administered every other week.
Time Frame: 30 weeks
30 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of adverse drug experiences between each treatment
Time Frame: 30 weeks
30 weeks
Compare the frequency of drug-related toxicities between each treatment arm
Time Frame: 30 weeks
30 weeks
Compare Quality of Life (QOL, patient-reported) measures (FACT-O, FOSI) between treatment arms.
Time Frame: 30 weeks
30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

September 12, 2008

First Submitted That Met QC Criteria

September 12, 2008

First Posted (Estimate)

September 16, 2008

Study Record Updates

Last Update Posted (Actual)

June 12, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

June 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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