Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma
Condition: Thymic Carcinoma
MeSH terms: Carcinoma; Thymoma
Intervention: Milciclib Maleate
Intervention description: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.
Number of cycles: until disease progression or unacceptable toxicity.
Intervention MeSH terms: Maleic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: B3 and C malignant thymoma

Summary:

      The intent of the study is to assess the antitumor activity of PHA-848125AC as second-line
      treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously
      treated with chemotherapy.
    

Eligibility criteria:

        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