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

Tracking Information

First Received Date ^ICMJE

September 12, 2008

Last Updated Date

June 3, 2009

Start Date ^ICMJE

September 2008

Estimated Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00753740 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Cancer
Ovarian Cancer
Solid Tumor

Intervention ^ICMJE

Drug: IT-101 (12mg/m2/dose)
Drug: IT-101 (15mg/m2/dose)
Drug: 5% Dextrose (Placebo)

Study Arms / Comparison Groups

Experimental: 12mg per meter squared per dose
Experimental: 15mg per meter squared per dose
Placebo Comparator: 5% dextrose infusion (placebo)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

May 2010

Estimated Primary Completion Date

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

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 78 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00753740

Responsible Party

James Oliver, Pharm. D., For Calando Pharmaceuticals

Study ID Numbers ^ICMJE

OVAR0801

Study Sponsor ^ICMJE

Calando Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Calando Pharmaceuticals

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP