A Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors
A Clinical Phase 1 Safety And Pharmacokinetic/Pharmacodynamic Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2008
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJune 27, 2011
June 1, 2011
2.3 years
October 28, 2008
June 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities
End of study
Secondary Outcomes (3)
To explore PD markers
End of study
To evaluate the plasma pharmacokinetics of PF-00299804 in Japanese patients following single and multiple dosing
End of study
To assess any clinical evidence of anti-tumor activity of PF-00299804 per RECIST
End of study
Study Arms (1)
1
EXPERIMENTALOpen label single arm trial
Interventions
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.
Eligibility Criteria
You may qualify if:
- Malignant solid tumor with no currently approved treatment
- Adequate functions Bone Marrow, Renal, Liver and Cardiac
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Sunto-gun, Shizuoka, Japan
Related Publications (1)
Takahashi T, Boku N, Murakami H, Naito T, Tsuya A, Nakamura Y, Ono A, Machida N, Yamazaki K, Watanabe J, Ruiz-Garcia A, Imai K, Ohki E, Yamamoto N. Phase I and pharmacokinetic study of dacomitinib (PF-00299804), an oral irreversible, small molecule inhibitor of human epidermal growth factor receptor-1, -2, and -4 tyrosine kinases, in Japanese patients with advanced solid tumors. Invest New Drugs. 2012 Dec;30(6):2352-63. doi: 10.1007/s10637-011-9789-z. Epub 2012 Jan 17.
PMID: 22249430DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 28, 2008
First Posted
October 31, 2008
Study Start
November 1, 2008
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
June 27, 2011
Record last verified: 2011-06