A Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors
Phase 1
Completed
- Conditions
- Neoplasms
- Interventions
- Drug: PF-00299804
- Registration Number
- NCT00783328
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
- Malignant solid tumor with no currently approved treatment
- Adequate functions Bone Marrow, Renal, Liver and Cardiac
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 PF-00299804 Open label single arm trial
- Primary Outcome Measures
Name Time Method Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities End of study
- Secondary Outcome Measures
Name Time Method To explore PD markers End of study To evaluate the plasma pharmacokinetics of PF-00299804 in Japanese patients following single and multiple dosing End of study To assess any clinical evidence of anti-tumor activity of PF-00299804 per RECIST End of study
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇯🇵Sunto-gun, Shizuoka, Japan