Study of CP-751,871 in Combination With Carboplatin and Paclitaxel in Advanced Lung Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00603538

Purpose

Investigate safety, tolerability and pharmacokinetics of CP-751,871 when given in combination with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: CP-751,871 + carboplatin + paclitaxel	Phase I

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 1, Dose Escalation Study of CP-751,871 in Combination With Carboplatin and Paclitaxel in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall safety profile [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Blood biomarkers [ Time Frame: End of study ] [ Designated as safety issue: No ]
Tumor responses [ Time Frame: End of study ] [ Designated as safety issue: No ]
Occurrence of anti-drug antibody [ Time Frame: End of study ] [ Designated as safety issue: No ]
Pharmacokinetics parameters [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CP-751,871: Experimental	Drug: CP-751,871 + carboplatin + paclitaxel Chemotherapy (carboplatin and paclitaxel) and CP-751,871 (6, 10 or 20mg/kg) will be administered by intravenous infusion every three weeks.

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of advanced non-small cell lung cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

Any prior treatment for non-small cell lung cancer
Brain metastases
With diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603538

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

Japan, Tokyo
Pfizer Investigational Site	Recruiting
Chuo-ku, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4021019, Japan CTPN 19-2409
Study First Received:	January 17, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00603538
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

CP-751,871, Non-small cell lung cancer, Phase 1

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms

Lung Diseases
Carboplatin
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009