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CT-2106 for the Second Line Treatment of Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CT-2106
Sponsored by
CTI BioPharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian, CT-2106

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

toxicity
response duration
time to progression
survival

Full Information

First Posted
February 14, 2006
Last Updated
February 24, 2010
Sponsor
CTI BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT00291837
Brief Title
CT-2106 for the Second Line Treatment of Ovarian Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CTI BioPharma

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian, CT-2106

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CT-2106
Primary Outcome Measure Information:
Title
response rate
Secondary Outcome Measure Information:
Title
toxicity
Title
response duration
Title
time to progression
Title
survival

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilary Calvert, PhD
Organizational Affiliation
Newcastle General Hospital
Official's Role
Principal Investigator
Facility Information:
City
Lyon
Country
France
City
Saint Brieuc
Country
France
City
Campobasso
Country
Italy
City
Birmingham
Country
United Kingdom
City
London
Country
United Kingdom
City
Newcastle upon Tyne
Country
United Kingdom
City
Surrey
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

CT-2106 for the Second Line Treatment of Ovarian Cancer

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