Recurrent or metastatic unresectable thymic carcinoma
Conditions
Interventions
Product Name: PHA-848125AC
Product Code: PHA-848125AC
Pharmaceutical Form: Capsule, hard
CAS Number: 802539-81-7
Current Sponsor code: P
Sponsors
Nerviano Medical Sciences S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the antitumor activity of PHA-848125AC as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy. Antitumor activity will be evaluated on the basis of the progression-free survival status at 3 months.; Secondary Objective: • Assessment of additional measures of tumor control to further characterize the efficacy profile of PHA-848125AC in recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy. • Evaluation of the safety profile of repeated administrations of PHA-848125AC in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy. Explorative Objective: Baseline characterization of selected biomarkers in tumor tissue of consenting patients ;Primary end point(s): • Progression-free survival rate at 3 months (PFS-3 rate). The PFS-3 rate, will be calculated as the proportion of evaluable patients known to be alive and progression-free at = 3 months since study treatment start out of the total number of evaluable patients. | — |
Countries
France, Italy
Outcome results
None listed