Neoplasms
Conditions
Keywords
solid tumor
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.
Interventions
DRUGPF-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.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities | End of study |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed