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

Cancer Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00753740
• Other study ID #: OVAR0801
• Status: Withdrawn
• Phase: Phase 2
• Start date: September 2008
• Est. completion date: May 2010

Study information

• Verified date: June 2020
• Source: Lumos Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT01565421

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 78 Years

Eligibility

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;

• 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.

Related Conditions & MeSH terms

• Cancer
• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
United States	Schwartz Gynecologic Onclology, PLLC	Brightwaters	New York
United States	Gabrail Cancer Center	Canton	Ohio
United States	Chattanooga GYN Oncology	Chattanooga	Tennessee
United States	Decatur Memorial Hospital, Clinical Research Department/ Cancer Care Specialists of Illinois	Decatur	Illinois
United States	The Methodist Hospital	Houston	Texas
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Riverside Gynecology & Oncology	Newport News	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
NewLink Genetics Corporation

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cheng J, Khin KT, Davis ME. Antitumor activity of beta-cyclodextrin polymer-camptothecin conjugates. Mol Pharm. 2004 May-Jun;1(3):183-93. — View Citation

Schluep T, Cheng J, Khin KT, Davis ME. Pharmacokinetics and biodistribution of the camptothecin-polymer conjugate IT-101 in rats and tumor-bearing mice. Cancer Chemother Pharmacol. 2006 May;57(5):654-62. Epub 2005 Aug 26. — View Citation

Schluep T, Hwang J, Cheng J, Heidel JD, Bartlett DW, Hollister B, Davis ME. Preclinical efficacy of the camptothecin-polymer conjugate IT-101 in multiple cancer models. Clin Cancer Res. 2006 Mar 1;12(5):1606-14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of adverse drug experiences between each treatment		30 weeks
Secondary	Compare the frequency of drug-related toxicities between each treatment arm		30 weeks
Secondary	Compare Quality of Life (QOL, patient-reported) measures (FACT-O, FOSI) between treatment arms.		30 weeks

External Links

•   Calando Pharmaceuticals Website