- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00753740
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
Status
Withdrawn
Conditions
Intervention / Treatment
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
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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.
Sponsor
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.
General Publications
- Schluep T, Hwang J, Cheng J, Heidel JD, Bartlett DW, Hollister B, Davis ME. Preclinical efficacy of the camptothecin-polymer conjugate IT-101 in multiple cancer models. Clin Cancer Res. 2006 Mar 1;12(5):1606-14. doi: 10.1158/1078-0432.CCR-05-1566.
- Schluep T, Cheng J, Khin KT, Davis ME. Pharmacokinetics and biodistribution of the camptothecin-polymer conjugate IT-101 in rats and tumor-bearing mice. Cancer Chemother Pharmacol. 2006 May;57(5):654-62. doi: 10.1007/s00280-005-0091-7. Epub 2005 Aug 26.
- Cheng J, Khin KT, Davis ME. Antitumor activity of beta-cyclodextrin polymer-camptothecin conjugates. Mol Pharm. 2004 May-Jun;1(3):183-93. doi: 10.1021/mp049966y.
Helpful Links
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
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Camptothecin
Other Study ID Numbers
- OVAR0801
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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