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

NCT ID: NCT00052065

Last Updated: 2011-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2006-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TLK286

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Telik

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Telik, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 20222977 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TLK286.2011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.