Phase 2 Study of TLK286 in Metastatic Breast Cancer | NCT00035841

Studies
Phase 2 Study of TLK286 in Metastatic Breast Cancer

NCT00035841

Sponsor

Telik

Status

Completed

Last Update Posted

Jul 25, 2011Estimated

Enrollment

Phase

Phase 2

Conditions

Breast 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

Apr 2002

Primary Completion Date

Jul 2004Actual

Completion Date

Jul 2004Actual

First Submitted Date

May 6, 2002

First Submission Date that Met QC Criteria

May 6, 2002

First Posted Date

May 7, 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

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 breast cancer
Metastatic disease
Measurable or evaluable disease
No prior chemotherapy regimens
Age at least 18 years
Adequate liver and kidney function
Adequate bone marrow function

Exclusion Criteria:

Pregnant or lactating women
Unstable medical conditions
Chemotherapy within 14 days of TLK286
Radiation therapy within 14 days of TLK286
Hormonal therapy within 14 days of TLK286
Immunotherapy within 14 days of TLK286
CNS metastasis unless controlled by treatment

Accepts Healthy Volunteers

Sex

All

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
Arizona Cancer Center		Tucson	Arizona	85724	United States
Indiana University Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin 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