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

Pfizer13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms

Interventions

PF-00299804DRUG

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Sunto-gun, Shizuoka, Japan

Outcomes

Primary Outcomes

Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities

Time frame: End of study

Secondary Outcomes

To explore PD markers

Time frame: End of study

To evaluate the plasma pharmacokinetics of PF-00299804 in Japanese patients following single and multiple dosing

Time frame: End of study

To assess any clinical evidence of anti-tumor activity of PF-00299804 per RECIST

Time frame: End of study

Data from ClinicalTrials.gov

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