Phase 2 Study of TLK286 in Platinum Resistant Advanced Ep... | NCT00038428

Studies
Phase 2 Study of TLK286 in Platinum Resistant Advanced Epithelial Ovarian Cancer

NCT00038428

Sponsor

Telik

Status

Completed

Last Update Posted

Jul 25, 2011Estimated

Enrollment

Phase

Phase 2

Conditions

Ovarian Neoplasms

Interventions

TLK286

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2001

Primary Completion Date

Jul 2005Actual

Completion Date

Jul 2005Actual

First Submitted Date

May 30, 2002

First Submission Date that Met QC Criteria

May 30, 2002

First Posted Date

May 31, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2011

Last Update Posted Date

Jul 25, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
TLK286	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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

Exclusion criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
USC/Norris Comprehensive Cancer Center		Los Angeles	California	90033	United States
Memorial Sloan-Kettering Cancer Center

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C107479	TER 286

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided