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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Recruitment Status : Withdrawn (Study was cancelled before patient enrollment)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.

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: docetaxel Drug: CP-868,596 + docetaxel Drug: AG-013736 + docetaxel Drug: CP-868,596 + AG-013736 + docetaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel




Primary Outcome Measures :
  1. 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 :
  1. Determine the safety and tolerability of the combination of daily CP 868,596 and docetaxel on an every 3 week schedule
  2. Determine the safety and tolerability of the combination of daily AG 013736 and docetaxel on an every 3 week schedule
  3. Determine the safety and tolerability of both CP 868,596 and AG 013736 given together with docetaxel on an every 3 week schedule
  4. Assess additional evidence of anti-tumor activity as measured by duration of objective response, progression-free survival, and one-year survival (OS1year)
  5. Evaluate the pharmacokinetics (PK) of AG 013736 and CP 868,596 when given together with and without docetaxel
  6. Evaluate the PK of CP 868,596 when given in combination with docetaxel
  7. Evaluate the PK of docetaxel when given in combination with CP 868,596, or CP 868,596 plus AG 01373


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Centrally-located tumors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386555


Sponsors and Collaborators
Arog Pharmaceuticals, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
ClinicalTrials.gov Identifier: NCT00386555     History of Changes
Other Study ID Numbers: A5301010
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: August 9, 2012
Last Verified: May 2007

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Crenolanib
Axitinib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors