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

NewLink Genetics

Status and phase: Withdrawn; Phase 2

Conditions: Solid Tumor; Cancer; Ovarian Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00753740

OVAR0801

Details and patient eligibility

About

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

Sex: Female

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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;
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

12mg/m2/dose

Experimental group

Description:

12mg per meter squared per dose

Treatment:

Drug: IT-101 (12mg/m2/dose)

15mg/m2/dose

Experimental group

Description:

15mg per meter squared per dose

Treatment:

Drug: IT-101 (15mg/m2/dose)

Placebo

Placebo Comparator group

Description:

5% dextrose infusion (placebo)

Treatment:

Drug: 5% Dextrose (Placebo)