Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer (NSCLC)
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00673049
First received: May 5, 2008
Last updated: May 21, 2012
Last verified: May 2012
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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 3 |
| 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:
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: | 583 |
| Study Start Date: | May 2008 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A
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: CP 751,871 (Figitumumab)
CP 751,871 (20 mg/kg) 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
Erlotinib (one tablet of 150 mg/day PO).
|
|
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 175 Study Locations
Show 175 Study LocationsSponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
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: | May 21, 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 May 22, 2013