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CompletedNCT00783328Updated Jun 27, 2011

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

A Phase 1 interventional study of PF-00299804 in Neoplasms, sponsored by Pfizer. Completed at 1 site in Japan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-06-27.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
13
Allocation
Non-randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Neoplasms

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Keywords

  • solid tumor
03

In context

Neoplasms

9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 13 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.

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Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Malignant solid tumor with no currently approved treatment
  • Adequate functions Bone Marrow, Renal, Liver and Cardiac

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    1

    Open label single arm trial

    Drug: PF-00299804

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.

06

What researchers measure

Primary outcomes

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

    Time frame: End of study

Secondary outcomes

  1. To explore PD markers

    Time frame: End of study

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

    Time frame: End of study

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

    Time frame: End of study

07

Study locations

1 site
  • Pfizer Investigational Site
    Sunto-gun, Shizuoka, Japan
08

References and documents

Publications

  • 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. PubMed 22249430 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00783328
Lead sponsor
Pfizer
First posted
Oct 31, 2008
Start date
Nov 2008
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Jun 27, 2011

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Dacomitinib

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