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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
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, see Learn About Clinical Studies.

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 November 20, 2014