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

This study has been withdrawn prior to enrollment.
(Study was cancelled before patient enrollment)
Information provided by:
Arog Pharmaceuticals, Inc. Identifier:
First received: October 6, 2006
Last updated: August 7, 2012
Last verified: May 2007
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 Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Arog Pharmaceuticals, Inc.:

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

Enrollment: 0
Study Start Date: May 2007

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Centrally-located tumors
  Contacts and Locations
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Please refer to this study by its identifier: NCT00386555

Sponsors and Collaborators
Arog Pharmaceuticals, Inc.
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information: Identifier: NCT00386555     History of Changes
Other Study ID Numbers: A5301010
Study First Received: October 6, 2006
Last Updated: August 7, 2012

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors processed this record on May 23, 2017