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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Dextrose

U.S. FDA Resources

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
Experimental: 12mg/m2/dose 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.
Experimental: 15mg/m2/dose 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 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.

Eligibility

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

Locations

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

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

More Information

Additional Information:

Calando Pharmaceuticals Website This link exits the ClinicalTrials.gov site

Publications:

Responsible Party:	James Oliver, Pharm. D., For Calando Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00753740 History of Changes
Other Study ID Numbers:	OVAR0801
Study First Received:	September 12, 2008
Last Updated:	June 3, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Calando Pharmaceuticals:

Cancer
Neoplasms
Solid Tumor
Ovarian Cancer
Solid Malignancies

Additional relevant MeSH terms:

Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases

Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on February 12, 2012