Efficacy Study of Maintenance Therapy for Ovarian Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01565421
Recruitment Status : Withdrawn (By previous sponsor)
First Posted : March 28, 2012
Last Update Posted : April 20, 2017
Information provided by (Responsible Party):
NewLink Genetics Corporation

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

Condition or disease Intervention/treatment Phase
Cancer Ovarian Cancer Solid Tumor Drug: IT-101 Drug: 5% Dextrose (Placebo) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : September 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: 12mg/m2/dose
12mg per meter squared per dose
Drug: IT-101
Patients who satisfy the inclusion/exclusion criteria will receive a blinded infusion of IT-101 (12mg/m2/dose) every other week until disease progression. (12mg/m2/dose)

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

Placebo Comparator: Placebo
5% dextrose infusion (placebo)
Drug: 5% Dextrose (Placebo)
Patients who satisfy the inclusion/exclusion criteria will receive an infusion of placebo every other week until disease progression.

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01565421

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

Additional Information:
Responsible Party: NewLink Genetics Corporation Identifier: NCT01565421     History of Changes
Other Study ID Numbers: ID OVAR0801
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by NewLink Genetics Corporation:
Solid Tumor
Ovarian Cancer
Solid Malignancies

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action