A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00557856

Purpose

The purpose of this study is to test the safety and effectiveness of PF-03446962 when given as a single agent. Tumors require new blood vessels to support their ability to grow and to spread (metastasize). New treatments aimed at preventing these blood vessels have the ability to improve the clinical management of cancer.

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: PF-03446962	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Phase 1 Pharmacokinetic And Pharmacodynamic Study Of PF-03446962 In Patients With Advanced Solid Tumors

Further study details as provided by Pfizer:

Primary Outcome Measures:

To determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PF-03446962 administered in patients with advanced solid tumors. [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Single dose and multi dose PK [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
Evaluation of immunogenicity [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
To document any preliminary evidence of antitumor activity [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
To assess the effect on vascular function adopting DCE MRI [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
To measure circulating endothelial cells (CEC), circulating endothelial progenitors (CEP) along with soluble proteins related to ALK 1 signaling [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
To establish the safety profile of PF-03446962 administered IV as single agent. [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	November 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: PF-03446962 To determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PF-03446962 administered in patients with advanced solid tumors.

Eligibility

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

Criteria

Inclusion Criteria:

Advanced measurable or non-measurable solid tumors.
Adequate bone marrow function.

Adequate liver function.

Adequate renal function.

Be able and willing to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

Exclusion Criteria:

Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of first dose of study medication.
Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, hemoptysis or melena in the past 6 months.
Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus; or any other active thromboembolic event.
QTc prolongation defined as QTc >450 msec.
Patients with known brain metastasis
Patients with peritoneal carcinosis at risk of bleeding
Major surgical procedure within 4 weeks of treatment
Pregnancy or breastfeeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557856

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

United States, Pennsylvania
Pfizer Investigational Site	Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Pfizer Investigational Site	Recruiting
Nashville, Tennessee, United States, 37232
Italy
Pfizer Investigational Site	Recruiting
Milano, Italy, 20141

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:	A8471001
Study First Received:	November 12, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00557856
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Solid Tumors, Transforming Growth Factor Beta, Activin Receptor-like Kinase 1

ClinicalTrials.gov processed this record on January 15, 2009