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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: PF-03446962

Study type

Interventional

Funder types

Industry

Identifiers

NCT00557856

2007-001422-27 (EudraCT Number)

A8471001

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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