Study of oral PHA-848125AC in patients with malignant thymoma previously treated with multiple lines of chemotherapy

Phase 1

Active, not recruiting

• Conditions: Recurrent or metastatic, unresectable B3 thymoma or thymic carcinoma previously treated with multiple lines of chemotherapy; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000344-25-IT
• Lead Sponsor: erviano Medical Sciences S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-27
• Study Completion: 2018-12-17
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

- Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic carcinoma recurrent or progressing after more than one prior systemic therapy for advanced / metastatic disease.
Note: Any adjuvant and neoadjuvant systemic therapy followed by the recurrence of the disease within 12 months after the start of the adjuvant treatment will be considered as one therapy for advanced / metastatic disease.
- Presence of measurable disease.
- Age = 18 years with ECOG performance status 0-1.
- Use of effective contraceptive methods if man and women of child producing potential.
- Adequate hematologic status: Absolute Neutrophils Count = 1,500 cells/mm3, Platelet Count = 100,000 cells/mm3, 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 metastases are present = 5 ULN).
- Adequate renal function: Serum Creatinine = ULN or Creatinine Clearance calculated by Cockcroft and Gault’s formula > 60 mL/min.
- 2 weeks or 5 medication half-lives (whichever is longer) must have elapsed since completion of prior systemic therapy and 2 weeks must have elapsed since completion of prior minor surgery and radiotherapy.
- Resolution of all acute toxic effects of any prior chemotherapy, surgery or radiotherapy to NCI CTC (Version 3.0) 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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 (with the exception of myasthenia gravis), 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified