Phase 2 Study of TLK286 Administered Weekly in Advanced N... | NCT00040638

Studies
Phase 2 Study of TLK286 Administered Weekly in Advanced Non-Small Cell Lung Cancer

NCT00040638

Sponsor

Telik

Status

Completed

Last Update Posted

Jul 25, 2011Estimated

Enrollment

Phase

Phase 2

Conditions

Carcinoma, Non-small-cell Lung

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

Jul 2002

Primary Completion Date

Aug 2003Actual

Completion Date

Aug 2003Actual

First Submitted Date

Jul 2, 2002

First Submission Date that Met QC Criteria

Jul 3, 2002

First Posted Date

Jul 4, 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 of TLK286 in the treatment of advanced non-small cell lung cancer.

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 or cytologic diagnosis of non-small cell lung carcinoma
Progressed while on or after treatment on platinum-based regimen
Patients may not have had more than one prior cytotoxic chemotherapy regimen
Stage IV or IIIB
Age at least 18 years
Adequate liver and kidney function
Adequate bone marrow function

Exclusion Criteria:

Pregnancy or lactation
Unstable medical conditions
Chemotherapy, hormonal therapy, radiotherapy, radiopharmaceuticals or immunotherapy within 3 weeks 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
UCLA Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

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