Know Cancer

or
forgot password

A Phase 1 Pharmacokinetic And Pharmacodynamic Study Of PF-03446962 In Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

A Phase 1 Pharmacokinetic And Pharmacodynamic Study Of PF-03446962 In Patients With Advanced Solid Tumors


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PF-03446962 administered in patients with advanced solid tumors.

Outcome Time Frame:

1.5 years

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A8471001

NCT ID:

NCT00557856

Start Date:

November 2007

Completion Date:

April 2013

Related Keywords:

  • Advanced Solid Tumors
  • Solid Tumors Transforming Growth Factor Beta Activin Receptor-like Kinase 1
  • Neoplasms

Name

Location

Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteBristol, Tennessee  37620