Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Previously Treated With Chemotherapy
Inclusion Criteria:
- Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic
carcinoma recurrent or progressing after prior chemotherapy (only one prior systemic
therapy allowed)
- Presence of measurable disease
- Age >=18 years
- ECOG performance status 0-1
- Negative pregnancy test (if female in reproductive years)
- Use of effective contraceptive methods if men and women of child producing potential
- Adequate liver function Total Serum Bilirubin <=1.5 x upper limit of normal (ULN)
Transaminases (AST/ALT) <=2.5ULN (if liver metastases are present, then <=5ULN is
allowed) ALP <=2.5ULN (if liver and/or bone metastases are present, then <=5ULN is
allowed)
- Adequate renal function Serum Creatinine <=ULN or Creatinine Clearance calculated by
Cockcroft and Gault's formula > 60 mL/min.
- Adequate hematologic status ANC >=1,500cells/mm3 Platelet Count >=100,000cells/mm3
Hemoglobin >=9.0g/dL
- Two weeks must have elapsed since completion of prior chemotherapy, minor surgery,
radiotherapy (provided that no more than 25% of bone marrow reserve has been
irradiated)
- Resolution of all acute toxic effects of any prior treatments to NCI CTC (Version
3.0) grade <=1
Exclusion Criteria:
- Any of the following in the past 6 months: myocardial infarction, uncontrolled
cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft,
symptomatic congestive heart failure, cerebrovascular accident or transient ischemic
attack, pulmonary embolism, deep vein thrombosis
- Grade >1 retinopathy
- Known brain metastases
- Known active infections
- Pregnant or breast feeding women
- Diabetes mellitus uncontrolled
- Gastrointestinal disease that would impact on drug absorption
- Patients under treatment with anticoagulants or with coagulation disorders or with
signs of hemorrhage at baseline
- Patients with previous history or current presence of neurological disorders,
including epilepsy (although controlled by anticonvulsant therapy), Parkinson's
disease and extra-pyramidal syndromes
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that make the patient inappropriate for entry into this study