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

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT00557856

Run by

Pfizer

People needed

70

Starts

2007-11-01

Expected to finish

2013-03-01

Last updated by the study team

2015-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina, Hollings Cancer Center — Charleston, South Carolina, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• S.C Diagnostica Radiologica 2 — Milan, Italy
• S.C. Chirurgia Generale Indirizzo Oncologico 1 (epato-gastro-pancreatica) — Milan, Italy
• S.C. Medicina Oncologica I, Fondazione IRCCS Istituto Nazionale Tumori — Milan, Italy
• Dipartimento di Medicina — Milan, Italy
• UO di Oncologia ed Ematologia, Istituto Clinico Humanitas-Humanitas Cancer Center — Rozzano (MI), Italy
• Seoul National University Hospital / Department of Internal Medicine — Seoul, South Korea

Full record on ClinicalTrials.gov

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