CT-2106 for the Second Line Treatment of Ovarian Cancer

Study Overview
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Brief Summary
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The purpose of this sudy is to determine the response rate of CT-2106 in patients with advanced ovarian cancer who have failed one prior platinum and taxane based regimen.

Official Title
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Phase II Open Label Study of CT-2106 as a Single Agent in Patients With Advanced Metastatic Ovarian Cancer Who Have Failed One Prior Platinum and Taxane Based Regimen

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: CT-2106


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes administered concomitantly At least one measurable lesion according to RECIST ECOG performance status 0 or 1 at least 18 years old Adequate haematological function Adequate renal and hepatic functions Normal coagulation parameters Exclusion Criteria: Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of > 12 months Pregnant or lactating patients Prior treatment with camptothecins Presence or history of CNS metastasis or carcinomatous leptomeningitis; Current active infection per investigator assessment; Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis; Current history of chronic diarrhea >= grade 1 (CTCAE version 3); Surgery or radiotherapy ≤ 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, ≤ 2 weeks before the 1st study treatment are allowed; Other uncontrolled, serious illness or medical condition, as determined by the investigator; Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation; Concurrent treatment with any other anti-cancer therapy; Known HIV positivity or AIDS-related illness; Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons.

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CT-2106|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity |  |  | 
| response duration |  |  | 
| time to progression |  |  | 
| survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian, CT-2106