NCT00038428

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2001

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

June 1, 2001

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2002

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

July 25, 2011

Status Verified

June 1, 2011

Enrollment Period

4.1 years

First QC Date

May 30, 2002

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:

  • 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

You may not qualify if:

  • Pregnant or currently breast feeding
  • Treatment with chemotherapy or immunotherapy within four weeks
  • Prior radiation to the whole pelvis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

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 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2002

First Posted

May 31, 2002

Study Start

June 1, 2001

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

July 25, 2011

Record last verified: 2011-06

Locations

US(3)