NCT00052065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2003

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

July 25, 2011

Status Verified

June 1, 2011

Enrollment Period

3.1 years

First QC Date

January 21, 2003

Last Update Submit

July 21, 2011

Conditions

Ovarian Neoplasms

Interventions

TLK286DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 20222977DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

TER 286

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 21, 2003

First Posted

January 23, 2003

Study Start

February 1, 2003

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

July 25, 2011

Record last verified: 2011-06

Locations

US(1)