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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: PF-00299804

Study type: Interventional

Funder types: Industry

Identifiers

NCT00783328

A7471005

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

1

Experimental group

Description:

Open label single arm trial

Treatment:

Drug: PF-00299804