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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00557856
First received: November 12, 2007
Last updated: August 16, 2013
Last verified: August 2013
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Pharmacokinetic And Pharmacodynamic Study Of PF-03446962 In Patients With Advanced Solid Tumors

Resource links provided by NLM:


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 ]

Enrollment: 70
Study Start Date: November 2007
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

Locations
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
Italy
Pfizer Investigational Site
Milano, Italy, 20141
Pfizer Investigational Site
Milano, Italy, 20132
Pfizer Investigational Site
Rozzano (MI), Italy, 20089
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Sponsors 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: NCT00557856     History of Changes
Other Study ID Numbers: A8471001
Study First Received: November 12, 2007
Last Updated: August 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Solid Tumors Transforming Growth Factor Beta Activin Receptor-like Kinase 1

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014