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

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NCT00783328

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Sunto-gun, Shizuoka, Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Malignant solid tumor with no currently approved treatment

- Adequate functions Bone Marrow, Renal, Liver and Cardiac

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00783328
Pfizer
Completed
A Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors

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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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms
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.
Other Name: Not specified
Experimental: 1
Open label single arm trial
Intervention: Drug: PF-00299804
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
March 2011
March 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00783328
A7471005
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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