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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00783328
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arm: 1
• Duration (Months): 27.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: PF-00299804	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Phase 1 Safety And Pharmacokinetic/Pharmacodynamic Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Open label single arm trial	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.

Outcome Measures

Primary Outcome Measures

1. Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities [End of study]

Secondary Outcome Measures

1. To explore PD markers [End of study]

2. To evaluate the plasma pharmacokinetics of PF-00299804 in Japanese patients following single and multiple dosing [End of study]

3. To assess any clinical evidence of anti-tumor activity of PF-00299804 per RECIST [End of study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Sunto-gun	Shizuoka	Japan

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00783328
• Other Study ID Numbers: A7471005
• First Posted: Oct 31, 2008
• Last Update Posted: Jun 27, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: solid tumor

Study Results

No Results Posted as of Jun 27, 2011