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Completed

NCT Number: NCT00783328

A 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.

Completed

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Key information

Conditions

Neoplasms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Sunto-gun, Shizuoka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-00299804

Drug

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.

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Clinical Phase 1 Safety And Pharmacokinetic/Pharmacodynamic Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 31, 2008
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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