Study of CP-751,871 in Combination With Sunitinib in Patients With Advanced Solid Tumors - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00729833

Purpose

The study is being conducted to determine the maximum tolerated dose, overall safety and tolerability profile, and pharmacokinetic profile of CP-751,871 and sunitinib when given in combination with advanced solid tumors.

Condition	Intervention	Phase
Advanced Cancer Advanced Solid Tumors	Drug: CP-751,871 Drug: Sunitinib	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Sunitinib Sunitinib malate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Phase 1, Open Label, Sequential Cohort, Dose Escalation Study of CP-751,871 in Combination With Sunitinib in Patients With Advanced Solid Tumors

Further study details as provided by Pfizer:

Primary Outcome Measures:

To determine the maximum tolerated dose (MTD) of CP-751,871 and sunitinib when given in combination in patients with advanced solid tumors [ Time Frame: 15Jan10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the potential development of Anti-Drug Antibodies (ADA) in response to CP-751,871 [ Time Frame: 15Jan10 ] [ Designated as safety issue: Yes ]
To document evidence of antitumor activity in patients with measurable disease, of CP-751,871 when given in combination with sunitinib [ Time Frame: 15Jan10 ] [ Designated as safety issue: Yes ]
To characterize the PK of CP-751,871 and sunitinib (and its metabolite SU012662) when given in combination [ Time Frame: 15Jan10 ] [ Designated as safety issue: Yes ]
To define the overall safety and tolerability profile of CP-751,871 and sunitinib when given in combination [ Time Frame: 15Jan10 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	45
Study Start Date:	September 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CP-751,871 + Sunitinib: Experimental Escalating cohorts of CP-751,871 + Sunitinib	Drug: CP-751,871 CP-751,871 IV, every 3 weeks Drug: Sunitinib Sunitinib - daily dosing

Eligibility

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

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed advanced solid tumors relapsed or refractory to standard therapy or for whom no standard therapy exists.
ECOG Performance Status of 0, 1, or 2
Adequate bone marrow, renal, and hepatic function
No mitral valve regurgitation greater than mild as determined by Doppler echocardiogram

Exclusion Criteria:

Concurrent treatment with any antitumor agents with the exception of LHRH agnosits for prostate cancer patients
treatment with any other investigational therapy within 4 weeks prior to study treatment
Major surgery within 4 weeks of study treatment
Ongoing cardiac dysrhythmias of NCI CTCAE Grade 2 or greater
Significant active cardiac disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729833

Contacts

Contact: EmergingMed	(877) 369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

United States, California
Pfizer Investigational Site	Recruiting
Santa Monica, California, United States, 90404
United States, Pennsylvania
Pfizer Investigational Site	Not yet recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Pfizer Investigational Site	Not yet recruiting
San Antonio, Texas, United States, 78229

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:	A4021024
Study First Received:	July 30, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00729833
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sunitinib

Additional relevant MeSH terms:

Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs

Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009