Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00673049

Purpose

The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

Condition	Intervention	Phase
Carcinoma, Large Cell Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma, Adenosquamous Cell	Drug: CP 751,871 (Figitumumab) Drug: Erlotinib	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall Survival [ Time Frame: 50 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the safety and tolerability of multiple doses of CP 751,871 [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
To assess the efficacy of CP 751,871 in terms of ORR [ Time Frame: 36 months ] [ Designated as safety issue: No ]
To monitor for the occurrence of anti drug antibody in response to CP 751,871 [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
To collect PK data of CP 751,871 for population PK meta-analysis [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
To test for the presence of plasma IGF-IR related markers [ Time Frame: 36 months ] [ Designated as safety issue: No ]
To assess the differences in health state utilities using the EQ-5D [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Progression Free Survival (PFS) [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment:	582
Study Start Date:	May 2008
Estimated Study Completion Date:	April 2012
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm A CP 751,871 (20 mg/kg) + erlotinib (150 mg/day) CP 751,871 will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.	Drug: CP 751,871 (Figitumumab) The CP 751,871 treatment in combination with erlotinib will be given in three week cycles. CP 751,871 (20 mg/kg) + erlotinib (150 mg/day). CP 751,871 will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter. Drug: Erlotinib The CP 751,871 treatment in combination with erlotinib will be given in three week cycles. CP 751,871 (20 mg/kg) + erlotinib (150 mg/day).
Active Comparator: Arm B Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food)	Drug: Erlotinib Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food.

Arms

Assigned Interventions

Experimental: Arm A

CP 751,871 (20 mg/kg) + erlotinib (150 mg/day) CP 751,871 will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.

Drug: CP 751,871 (Figitumumab)

The CP 751,871 treatment in combination with erlotinib will be given in three week cycles. CP 751,871 (20 mg/kg) + erlotinib (150 mg/day). CP 751,871 will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.

Drug: Erlotinib

The CP 751,871 treatment in combination with erlotinib will be given in three week cycles. CP 751,871 (20 mg/kg) + erlotinib (150 mg/day).

Active Comparator: Arm B

Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food)

Drug: Erlotinib

Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food.

Detailed Description:

This study was terminated on March 8, 2010 due to an analysis by an independent Data Safety Monitoring Committee (DSMC) indicating that the addition of CP-751,871 [figitumumab] to erlotinib [Tarceva] would be unlikely to meet the primary endpoint of improving overall survival when compared to erlotinib alone.

This Oncology study continues as terminated, however for ethical reasons some patients, noted with resultant benefit, continue receiving treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Non small cell lung cancer with a primary histology of squamous cell, large cell or adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.

Exclusion Criteria:

Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.
Prior Erlotinib therapy.
Prior anti IGF IR based investigational therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673049

Show 172 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00673049 History of Changes
Other Study ID Numbers:	A4021018
Study First Received:	May 5, 2008
Last Updated:	January 14, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

IGR-1R
Non small cell lung cancer
CP-751
871
Figitumumab

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Lung Neoplasms
Carcinoma, Adenosquamous
Carcinoma, Large Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Squamous Cell
Neoplasms, Complex and Mixed
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012