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A Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel.

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ClinicalTrials.gov Identifier: NCT00386555
Recruitment Status : Withdrawn (Study was cancelled before patient enrollment)
First Posted : October 11, 2006
Last Update Posted : August 9, 2012
Sponsor:
Information provided by:
Arog Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE October 6, 2006
First Posted Date  ICMJE October 11, 2006
Last Update Posted Date August 9, 2012
Study Start Date  ICMJE May 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2006)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00386555 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2007)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2006)
  • 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 013736
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: docetaxel
  • Drug: CP-868,596 + docetaxel
  • Drug: AG-013736 + docetaxel
  • Drug: CP-868,596 + AG-013736 + docetaxel
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 7, 2012)
0
Original Enrollment  ICMJE
 (submitted: October 10, 2006)
139
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Platinum-pretreated patients with advanced stage IIIb or IV NSCLC

Exclusion Criteria:

  • Centrally-located tumors
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00386555
Other Study ID Numbers  ICMJE A5301010
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Arog Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Arog Pharmaceuticals, Inc.
Verification Date May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP