A Clinical Phase 1 Safety And Pharmacokinetic/Pharmacodynamic Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors
Phase 1
20 Years
75 Years
20 Years
75 Years
Not Enrolling
Both
Neoplasms
Both
Neoplasms
Trial Information
A Clinical Phase 1 Safety And Pharmacokinetic/Pharmacodynamic Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities
Outcome Time Frame:
End of study
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Japan: Institutional Review Board
Study ID:
A7471005
NCT ID:
NCT00783328
Start Date:
November 2008
Completion Date:
March 2011
Related Keywords:
- Neoplasms
- solid tumor
- Neoplasms
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