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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00783328
First received: October 28, 2008
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Neoplasms
Drug: PF-00299804
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To explore PD markers [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • To evaluate the plasma pharmacokinetics of PF-00299804 in Japanese patients following single and multiple dosing [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • To assess any clinical evidence of anti-tumor activity of PF-00299804 per RECIST [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: November 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783328

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

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00783328     History of Changes
Other Study ID Numbers: A7471005
Study First Received: October 28, 2008
Last Updated: June 22, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Pfizer:
solid tumor

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 22, 2014