Phase II study of oral PHA-848125AC in patients with thymic carcinoma previously treated with chemotherapy
- Conditions
- Recurrent or metastatic unresectable thymic carcinoma
- Registration Number
- EUCTR2009-014338-79-FR
- Lead Sponsor
- erviano Medical Sciences S.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
- Histologically or cytologically proven diagnosis of unresectable thymic carcinoma recurrent or progressing after prior chemotherapy (only one prior systemic therapy allowed).
- Presence of measurable disease
- Age = 18 years with ECOG performance status 0-1
- Use of effective contraceptive methods if men and women of child producing potential
- Adequate hematologic status: Absolute neutrophils count =1,500 cells/mm3, platelet count =100,000 cells/mm3 and hemoglobin =9.0 g/dL.
- Adequate liver function: Total Serum Bilirubin=1.5 x upper limit of normal (ULN), Transaminases (AST/ALT) = 2.5 ULN (if liver metastases are present = 5 ULN), ALP = 2.5 ULN (if liver and/or bone marrow metastases are present = 5 ULN)
- Adequate renal function: Serum Creatinine = ULN
- 2 weeks must have elapsed since completion of prior chemotherapy
- Resolution of all acute toxic effects of any prior treatments to NCI CTC (Version 3) grade =1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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 as determined by an ophthalmologist
- Known brain metastases.
- Known active infections
- Pregnant or breast feeding women.
- Diabetes mellitus uncontrolled.
- Gastrointestinal disease (e.g. Crohn’s disease, ulcerative colitis, or short gut syndrome) 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 patients inappropriate for entry into this study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method