Clinical trial · Interventional
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
NCT00783328CI-TRIAL-00005081completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-00299804 | Drug | Dacomitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Open label single arm trial
- interventionNames
- Drug: PF-00299804
Primary outcomes (1)
- measure
- Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities
- timeFrame
- End of study
Secondary outcomes (3)
- measure
- To explore PD markers
- timeFrame
- End of study
- measure
- To evaluate the plasma pharmacokinetics of PF-00299804 in Japanese patients following single and multiple dosing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTakahashi 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 22249430