NCT00753740

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

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.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NewLink Genetics Corporation · Industry
• Sex: Female
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Cancer
• Ovarian Cancer
• Solid Tumor

Interventions

Type	Name	Description
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.
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.
DRUG	5% Dextrose (Placebo)	Patients who satisfy the inclusion/exclusion criteria will receive an infusion of placebo every other week until disease progression.

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-10-01
• Completion: 2010-05-01
• First posted: 2008-09-16
• Last updated: 2020-06-12

Locations

7 sites across 1 country: United States