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

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

Official Title
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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.

Conditions
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Cancer, Ovarian Cancer, Solid Tumor

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12mg/m2/dose<br>12mg per meter squared per dose | Drug: IT-101 (12mg/m2/dose)<br>* Patients who satisfy the inclusion/exclusion criteria will receive a blinded infusion of IT-101 (12mg/m2/dose) every other week until disease progression.<br>|
| Experimental: 15mg/m2/dose<br>15mg per meter squared per dose | Drug: IT-101 (15mg/m2/dose)<br>* Patients who satisfy the inclusion/exclusion criteria will receive an infusion of IT-101 (15mg/m2) every other week until disease progression.<br>|
| Placebo Comparator: Placebo<br>5% dextrose infusion (placebo) | Drug: 5% Dextrose (Placebo)<br>* Patients who satisfy the inclusion/exclusion criteria will receive an infusion of placebo every other week until disease progression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Neoplasms, Solid Tumor, Ovarian Cancer, Solid Malignancies