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

Phase 2

Withdrawn

• Conditions: Ovarian Cancer; Solid Tumor; Cancer
• Interventions: Drug: IT-101 (15mg/m2/dose); Drug: IT-101 (12mg/m2/dose); Drug: 5% Dextrose (Placebo)

• Registration Number: NCT00753740
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-12
• Study First Submitted QC: 2008-09-12
• Study First Posted: 2008-09-16
• Primary Completion: 2009-10
• Study Completion: 2010-05
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15mg/m2/dose	IT-101 (15mg/m2/dose)	15mg per meter squared per dose
12mg/m2/dose	IT-101 (12mg/m2/dose)	12mg per meter squared per dose
Placebo	5% Dextrose (Placebo)	5% dextrose infusion (placebo)

Primary Outcome Measures

Name	Time	Method
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.	30 weeks

Secondary Outcome Measures

Name	Time	Method
Comparison of adverse drug experiences between each treatment	30 weeks
Compare the frequency of drug-related toxicities between each treatment arm	30 weeks
Compare Quality of Life (QOL, patient-reported) measures (FACT-O, FOSI) between treatment arms.	30 weeks

Trial Locations

Locations (7)

Schwartz Gynecologic Onclology, PLLC; 🇺🇸 Brightwaters, New York, United States

Riverside Gynecology & Oncology; 🇺🇸 Newport News, Virginia, United States

Decatur Memorial Hospital, Clinical Research Department/ Cancer Care Specialists of Illinois; 🇺🇸 Decatur, Illinois, United States

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

The Methodist Hospital; 🇺🇸 Houston, Texas, United States

Gabrail Cancer Center; 🇺🇸 Canton, Ohio, United States

Chattanooga GYN Oncology; 🇺🇸 Chattanooga, Tennessee, United States