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

Neoplasms Clinical Trial

Official title:

A Clinical Phase 1 Safety And Pharmacokinetic/Pharmacodynamic Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783328
• Other study ID #: A7471005
• Status: Completed
• Phase: Phase 1
• First received: October 28, 2008
• Last updated: June 22, 2011
• Start date: November 2008
• Est. completion date: March 2011

Study information

• Verified date: June 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Sunto-gun	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities		End of study	Yes
Secondary	To explore PD markers		End of study	No
Secondary	To evaluate the plasma pharmacokinetics of PF-00299804 in Japanese patients following single and multiple dosing		End of study	No
Secondary	To assess any clinical evidence of anti-tumor activity of PF-00299804 per RECIST		End of study	No

External Links

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