Back to resultsPhase 2 Study of TLK286 in Platinum Resistant Advanced Epithelial Ovarian Cancer
Primary Purpose
Ovarian Neoplasms
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TLK286
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Neoplasms
Eligibility Criteria
Inclusion Criteria Histologic diagnosis of ovarian cancer Recurrent or persistent disease following primary therapy Measurable disease Prior treatment with at least one but no more than three prior chemotherapy regimens Resistant or refractory to platinum-based chemotherapy At least 18 years of age Good performance status (ECOG 0 to 1) Adequate liver, renal and bone marrow function Exclusion criteria Pregnant or currently breast feeding Treatment with chemotherapy or immunotherapy within four weeks Prior radiation to the whole pelvis
Sites / Locations
- USC/Norris Comprehensive Cancer Center
- Memorial Sloan-Kettering Cancer Center
- M.D. Anderson Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00038428
Brief Title
Phase 2 Study of TLK286 in Platinum Resistant Advanced Epithelial Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Telik
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every week in the treatment of patients with advanced ovarian cancer that is resistant to platinum-based chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms
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)
TLK286
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Histologic diagnosis of ovarian cancer
Recurrent or persistent disease following primary therapy
Measurable disease
Prior treatment with at least one but no more than three prior chemotherapy regimens
Resistant or refractory to platinum-based chemotherapy
At least 18 years of age
Good performance status (ECOG 0 to 1)
Adequate liver, renal and bone marrow function
Exclusion criteria
Pregnant or currently breast feeding
Treatment with chemotherapy or immunotherapy within four weeks
Prior radiation to the whole pelvis
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase 2 Study of TLK286 in Platinum Resistant Advanced Epithelial Ovarian Cancer
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