search
Back to results

TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer

Primary Purpose

Ovarian Neoplasms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TLK286
Sponsored by
Telik
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasms

Eligibility Criteria

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

Inclusion Criteria Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube cancer or primary peritoneal cancer Recurrent epithelial ovarian cancer or persistent disease following primary treatment At least one, but no more than four, prior platinum-containing chemotherapy regimens At least one prior taxane-containing regimen Exclusion Criteria A 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 the patient has been disease-free for 2 years Known leptomeningeal metastases or carcinomatous meningitis Have received prior Doxil or other liposomal doxorubicin Having received whole pelvis radiation therapy

Sites / Locations

  • M.D. Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 21, 2003
Last Updated
July 21, 2011
Sponsor
Telik
search

1. Study Identification

Unique Protocol Identification Number
NCT00052065
Brief Title
TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer
Official Title
Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (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 Doxil in patients with platinum refractory or resistant 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 cancer or primary peritoneal cancer Recurrent epithelial ovarian cancer or persistent disease following primary treatment At least one, but no more than four, prior platinum-containing chemotherapy regimens At least one prior taxane-containing regimen Exclusion Criteria A 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 the patient has been disease-free for 2 years Known leptomeningeal metastases or carcinomatous meningitis Have received prior Doxil or other liposomal doxorubicin Having received whole pelvis radiation therapy
Facility Information:
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20222977
Citation
Kavanagh JJ, Levenback CF, Ramirez PT, Wolf JL, Moore CL, Jones MR, Meng L, Brown GL, Bast RC Jr. Phase 2 study of canfosfamide in combination with pegylated liposomal doxorubicin in platinum and paclitaxel refractory or resistant epithelial ovarian cancer. J Hematol Oncol. 2010 Mar 11;3:9. doi: 10.1186/1756-8722-3-9.
Results Reference
derived

Learn more about this trial

TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer

We'll reach out to this number within 24 hrs