- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00783328
A Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors
June 22, 2011 updated by: Pfizer
A Clinical Phase 1 Safety And Pharmacokinetic/Pharmacodynamic Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors
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 Overview
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shizuoka
-
Sunto-gun, Shizuoka, Japan
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Open label single arm trial
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities
Time Frame: End of study
|
End of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To explore PD markers
Time Frame: End of study
|
End of study
|
To evaluate the plasma pharmacokinetics of PF-00299804 in Japanese patients following single and multiple dosing
Time Frame: End of study
|
End of study
|
To assess any clinical evidence of anti-tumor activity of PF-00299804 per RECIST
Time Frame: End of study
|
End of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
October 28, 2008
First Submitted That Met QC Criteria
October 30, 2008
First Posted (Estimate)
October 31, 2008
Study Record Updates
Last Update Posted (Estimate)
June 27, 2011
Last Update Submitted That Met QC Criteria
June 22, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- A7471005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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