Back to resultsTLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer
Primary Purpose
Ovarian Neoplasms
Status
Completed
Phase
Phase 1
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 Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer Recurrent ovarian cancer or persistent disease following primary treatment At least one, but no more than four, prior chemotherapy regimens (all platinum-containing counted as one) At least 18 years of age Exclusion Criteria Pregnant or lactating women History of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which patient has been disease-free for at least 2 years Known leptomeningeal metastases or carcinomatous meningitis Having received whole pelvis radiation therapy
Sites / Locations
- Santa Monica Hematology/Oncology Consultants
- Midwest Cancer Research Group, Inc.
- Beth Israel Deaconess Medical Center
- Dana Farber Cancer Institute
- Massachusetts General Hospital
- M.D. Anderson Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00051948
Brief Title
TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer
Official Title
Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Telik
4. Oversight
5. Study Description
Brief Summary
This is a dose-ranging, open label, Phase 1-2a study of TLK286 in combination with Paraplatin (carboplatin) in patients with recurrent ovarian cancer.
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 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (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
Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer
Recurrent ovarian cancer or persistent disease following primary treatment
At least one, but no more than four, prior chemotherapy regimens (all platinum-containing counted as one)
At least 18 years of age
Exclusion Criteria
Pregnant or lactating women
History of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which patient has been disease-free for at least 2 years
Known leptomeningeal metastases or carcinomatous meningitis
Having received whole pelvis radiation therapy
Facility Information:
Facility Name
Santa Monica Hematology/Oncology Consultants
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Midwest Cancer Research Group, Inc.
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
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
TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer
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