A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00728390
• Collaborator: (none)
• Enrollment: 74
• Locations: 5
• Arm: 1
• Duration (Months): 54
• Patients Per Site: 14.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study will explore the combination of the oral drug PF-00299804 and intravenous CP-751,871 in patients with advanced solid tumor. Each of these drugs have been given separately to patients in prior studies, and this study is to establish the safety and efficacy of the combination.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small Cell; Neoplasm Metastasis	Drug: PF-00299804	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1 Targeted Combination Trial Of PF-00299804 And CP-751,871 In Patients With Advanced Solid Tumors
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: PF-00299804; CP-751,871 at recommended dose on Day 1 and 2 of cycle 1, then on Day 1 every 3 weeks; and PF-00299804 orally at recommended dose once daily.

Outcome Measures

Primary Outcome Measures

1. Overall safety profile characterized by type, frequency, severity (as graded using NCI CTC AE v. 3.0), timing, seriousness and relationship to trial treatment of adverse events and laboratory abnormalities. [18 months]

Secondary Outcome Measures

1. Plasma Pharmacokinetic Parameters of PF-00299804 and CP-751,871 [12 months]

2. Progression Free Survival (PFS) [15 months]

3. Best overall response (OR) defined according to RECIST guidelines. [12 months]

4. Duration of response (DR) [15 months]

5. Anti-Drug Antibodies (ADA) response; [18 months]

6. KRAS mutation and EGFR gene amplification and mutation status in available NSCLC tumor tissue (fresh or archived) (NSCLC MTD Expansion Cohort [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically documented advanced cancer, Eastern Cooperative Oncology Group (ECOG) 0-1;

• Platelets > 100,000, ANC > 1500;

• Ccr > 60 or serum creat. <1.5

• Non-small cell cancer cohort:

• Eastern Cooperative Oncology Group (ECOG) 0-2, prior platin, < 4 prior chemotherapy regimen

• HgA1C <5.7%

Exclusion Criteria:

• Active Central Nervous System (CNS) metastases;

• prior IGF1-R targeted therapy

• Any history of unstable angina, myocardial infarction or symptomatic congestive heart failure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Amherst	New York	United States	14221
2	Pfizer Investigational Site	Buffalo	New York	United States	14263
3	Pfizer Investigational Site	San Antonio	Texas	United States	78229
4	Pfizer Investigational Site	Villejuif		France	94805
5	Pfizer Investigational Site	Madrid		Spain	28050

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00728390
• Other Study ID Numbers: A7471004
• First Posted: Aug 5, 2008
• Last Update Posted: Oct 8, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Pfizer: advanced cancer refractory advanced non-small cell lung cancer
• Additional relevant MeSH terms: Neoplasm Metastasis

Study Results

No Results Posted as of Oct 8, 2013