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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Open label single arm trial

Group Type EXPERIMENTAL

PF-00299804

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No