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

Phase 1 Targeted Combination Trial Of PF-00299804 And CP-751,871 In Patients With Advanced Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00728390

Enrollment

Registered

2008-08-05

Start date

2008-12-15

Completion date

2013-01-29

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small Cell, Neoplasm Metastasis

Keywords

advanced cancer refractory advanced non-small cell lung cancer

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.

Interventions

DRUGPF-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Progression Free Survival (PFS)	15 months
Best overall response (OR) defined according to RECIST guidelines.	12 months
Plasma Pharmacokinetic Parameters of PF-00299804 and CP-751,871	12 months
Anti-Drug Antibodies (ADA) response;	18 months
KRAS mutation and EGFR gene amplification and mutation status in available NSCLC tumor tissue (fresh or archived) (NSCLC MTD Expansion Cohort	12 months
Duration of response (DR)	15 months

Countries

France, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026