Back to resultsA Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel.
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
docetaxel
CP-868,596 + docetaxel
AG-013736 + docetaxel
CP-868,596 + AG-013736 + docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung
Eligibility Criteria
Inclusion Criteria:
- Platinum-pretreated patients with advanced stage IIIb or IV NSCLC
Exclusion Criteria:
- Centrally-located tumors
Sites / Locations
Outcomes
Primary Outcome Measures
Determine the anti-tumor efficacy of CP 868,596 plus docetaxel, AG 013736 plus docetaxel, CP 868,596 plus AG 013736 plus docetaxel, and docetaxel alone in patients with advanced NSCLC based on objective tumor response (CR and PR) rate
Secondary Outcome Measures
Determine the safety and tolerability of the combination of daily CP 868,596 and docetaxel on an every 3 week schedule
Determine the safety and tolerability of the combination of daily AG 013736 and docetaxel on an every 3 week schedule
Determine the safety and tolerability of both CP 868,596 and AG 013736 given together with docetaxel on an every 3 week schedule
Assess additional evidence of anti-tumor activity as measured by duration of objective response, progression-free survival, and one-year survival (OS1year)
Evaluate the pharmacokinetics (PK) of AG 013736 and CP 868,596 when given together with and without docetaxel
Evaluate the PK of CP 868,596 when given in combination with docetaxel
Evaluate the PK of docetaxel when given in combination with CP 868,596, or CP 868,596 plus AG 01373
Full Information
NCT ID
NCT00386555
First Posted
October 6, 2006
Last Updated
August 7, 2012
Sponsor
Arog Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00386555
Brief Title
A Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel.
Official Title
Phase 2 Study of CP-868,596 + Docetaxel, AG-013736 + Docetaxel, or CP-868,596 + AG-013736 + Docetaxel and of Docetaxel Alone in Patients With Stage IIIb or IV Non-Small Cell Lung Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Withdrawn
Why Stopped
Study was cancelled before patient enrollment
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Arog Pharmaceuticals, Inc.
4. Oversight
5. Study Description
Brief Summary
To determine the effectiveness of CP-868,596 + docetaxel, AG-013736 + docetaxel and CP-868,596 + AG-013736 + docetaxel in patients previously treated for non-small cell lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
CP-868,596 + docetaxel
Intervention Type
Drug
Intervention Name(s)
AG-013736 + docetaxel
Intervention Type
Drug
Intervention Name(s)
CP-868,596 + AG-013736 + docetaxel
Primary Outcome Measure Information:
Title
Determine the anti-tumor efficacy of CP 868,596 plus docetaxel, AG 013736 plus docetaxel, CP 868,596 plus AG 013736 plus docetaxel, and docetaxel alone in patients with advanced NSCLC based on objective tumor response (CR and PR) rate
Secondary Outcome Measure Information:
Title
Determine the safety and tolerability of the combination of daily CP 868,596 and docetaxel on an every 3 week schedule
Title
Determine the safety and tolerability of the combination of daily AG 013736 and docetaxel on an every 3 week schedule
Title
Determine the safety and tolerability of both CP 868,596 and AG 013736 given together with docetaxel on an every 3 week schedule
Title
Assess additional evidence of anti-tumor activity as measured by duration of objective response, progression-free survival, and one-year survival (OS1year)
Title
Evaluate the pharmacokinetics (PK) of AG 013736 and CP 868,596 when given together with and without docetaxel
Title
Evaluate the PK of CP 868,596 when given in combination with docetaxel
Title
Evaluate the PK of docetaxel when given in combination with CP 868,596, or CP 868,596 plus AG 01373
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Platinum-pretreated patients with advanced stage IIIb or IV NSCLC
Exclusion Criteria:
Centrally-located tumors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5301010&StudyName=A+Phase+2+Study+in+Patients+with+Advanced+Non%2DSmall+Cell+Lung+Cancer+Using+New+Agents+With+and+Without+Docetaxel%2E+
Description
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Learn more about this trial
A Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel.
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