We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

A Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00783328
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : June 27, 2011
Information provided by:

Brief Summary:
To evaluate safety and tolerability of PF-00299804 in Japanese patients with advanced malignant solid tumors at doses up to the clinically recommended phase 2 dose in non-Japanese studies.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: PF-00299804 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Phase 1 Safety And Pharmacokinetic/Pharmacodynamic Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors
Study Start Date : November 2008
Primary Completion Date : March 2011
Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: 1
Open label single arm trial
Drug: PF-00299804
Dosage form: 5 mg and 20 mg tablet Dosage: 15 mg, 30 mg and 45 mg, orally, once daily Number of Cycles: until progression or unacceptable toxicity develops.
Other Name: Not specified

Primary Outcome Measures :
  1. Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities [ Time Frame: End of study ]

Secondary Outcome Measures :
  1. To explore PD markers [ Time Frame: End of study ]
  2. To evaluate the plasma pharmacokinetics of PF-00299804 in Japanese patients following single and multiple dosing [ Time Frame: End of study ]
  3. To assess any clinical evidence of anti-tumor activity of PF-00299804 per RECIST [ Time Frame: End of study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Malignant solid tumor with no currently approved treatment
  • Adequate functions Bone Marrow, Renal, Liver and Cardiac

Exclusion Criteria:

  • Any surgery, radiotherapy within 4 weeks of baseline disease assessments
  • Clinically significant abnormalities of the cornea
  • Patients with symptomatic brain/central nerve system metastases
  • Any clinically significant gastrointestinal abnormalities
  • Uncontrolled or significant cardiovascular disease
  • Patients with significant interstitial pneumonia or pulmonary fibrosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783328

Pfizer Investigational Site
Sunto-gun, Shizuoka, Japan
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer