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

Sponsored by:	Calando Pharmaceuticals
Information provided by:	Calando Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00753740

Purpose

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

Condition	Intervention	Phase
Cancer Ovarian Cancer Solid Tumor	Drug: IT-101 (12mg/m2/dose) Drug: IT-101 (15mg/m2/dose) Drug: 5% Dextrose (Placebo)	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

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.

Further study details as provided by Calando Pharmaceuticals:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of adverse drug experiences between each treatment [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
Compare the frequency of drug-related toxicities between each treatment arm [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
Compare Quality of Life (QOL, patient-reported) measures (FACT-O, FOSI) between treatment arms. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:

150

Study Start Date:

September 2008

Estimated Study Completion Date:

May 2010

Estimated Primary Completion Date:

October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
12mg/m2/dose: Experimental 12mg per meter squared per dose	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.
15mg/m2/dose: Experimental 15mg per meter squared per dose	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.
Placebo: Placebo Comparator 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.

Eligibility

Ages Eligible for Study:

18 Years to 78 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753740

Contacts

Contact: Jamie Oliver, Pharm. D.

(919) 851-4870

Locations

United States, Illinois
Decatur Memorial Hospital, Clinical Research Department/ Cancer Care Specialists of Illinois	Recruiting
Decatur, Illinois, United States, 62526
Contact: Laura Boyd, RN 217-876-6620
Principal Investigator: James Wade, MD
United States, New York
Schwartz Gynecologic Onclology, PLLC	Recruiting
Brightwaters, New York, United States, 11718
Contact: Jaclyn Frizalone, CRC 631-376-0055 ext 106
Contact: Debolina Kowshik, CRC 631-376-0055 ext 107
Principal Investigator: Benjamin M Schwartz, MD
United States, Ohio
Gabrail Cancer Center	Recruiting
Canton, Ohio, United States, 44718
Contact: Carrie Smith 330-492-3345 ext 208
Principal Investigator: Nashat Y Gabrail, MD
United States, Tennessee
Chattanooga GYN Oncology	Recruiting
Chattanooga, Tennessee, United States, 97403
Contact: Colleen F Canion, RN 423-698-2050
Principal Investigator: Donald H Chamberlain, MD
United States, Texas
The Methodist Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Sonia (Carol) Robazetti-Hodgson 713-441-6616
Principal Investigator: Tri A Dinh, MD
United States, Virginia
Riverside Gynecology & Oncology	Recruiting
Newport News, Virginia, United States, 23601
Contact: Ora Mae Jackson, RN 757-534-5565
Principal Investigator: William P Irvin, MD

Sponsors and Collaborators

Calando Pharmaceuticals

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