Patients with locally advanced and/ or metastasized carcinoma for whom no further evidence-based drug treatment is established.A progression of the tumor is confirmed due to the last evidence-based drug therapy. Due to circulating tumor-DNA (ctDNA) in a blood sample and/or tissue sample of metastasis, a molecular-biologic tumor profiling is performed and an adapted tumor-specific drug therapy is selected.
Conditions
Interventions
Trade Name: Zytiga
Pharmaceutical Form: Tablet
CAS Number: 154229-18-2
Other descriptive name: ABIRATERONE ACETATE
Concentration unit: mg milligram(s)
Concentration type: not less then
Concentration n
Sponsors
Medical University of Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male/ female patients with locally advanced and/ or metastasized carcinoma for whom no further evidence-based drug therapy is established. 2. Diagnosis of unresectable locally advanced and/or metastatic carcinoma with histologically confirmed disease 3. Confirmed progression after evidence-based drug therapy and no option for further evidence-based drug therapy (at least one phase III study) in this indication 4. Age >18 years - =85 5. Life expectancy of at least 12 weeks 6. Measureable disease according to the revised RECIST criteria version 1.1. (Eisenhauer, E.A., et al., New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer, 2009. 45(2): p. 228-47.) Das ist die Referenz 3 7. ECOG score 0-2 (Appendix A) 8. Adequate bone marrow, liver and kidney function: laboratory cut-off levels according to the registration of registered drugs (will be checked again before treatment start) 9. No anti-tumor therapy including radiotherapy in the past two weeks. 10. Written informed consent 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: 1. Significant comorbidity which is expected to affect patient's prognosis or ability to receive therapy: a. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/ third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) class II or worse (slight limitation of physical activity; comfortable at rest but ordinary activity results in fatigue, palpitation or dyspnea). b. History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial. c. Active infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol therapy. d. History of any psychiatric condition that might impair the patient's ability to understand or comply with the requirements of the study or to provide consent. e. Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs 2. Untreated CNS metastases. Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 2 weeks prior to treatment start, or after surgical resection performed at least 28 days prior to treatment start. 3. Previously diagnosed malignancies except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease free for at least 5 years. 4. Pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This phase II study is designed to increase the PFS of an anti-tumor drug therapy based on a molecular-biologic tumor profile in patients with proven progressed carcinoma of different origin after all evidence-based therapies 1.2-fold to the PFS of the last evidence-based drug therapy. Furthermore, the number of patients in which an anti-tumor drug therapy based on a molecular-biologic tumor profile can be defined, overall survival (OS), overall response rate (ORR) and safety will be evaluated. PFS ratio (PFS on targeted drug therapy / PFS on last evidence-based drug therapy). The PFS of the last evidence-based therapy will be assessed by predefined specialist of the Division of Clinical Oncology of the Medical University of Graz who take part in the study at the time when a patient is included in the study.;Secondary Objective: Number of patients in whom an anti-tumor drug therapy based on a molecular-biologic tumor profile can be defined. Progression-free survival (PFS). Overall survival (OS)Overall response rate (ORR). Safety. ;Primary end point(s): - Progression-free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of patients for whom an anti-tumor drug therapy based on a molecular-biologic tumor profile can be defined. - Overall survival (OS) measured from the date of enrolment into the trial to the date of death or censored at the date of last follow-up. - Overall response rate (ORR) based on RECIST criteria 1.1. - Adverse events, severity and frequency, associated with anti-cancer drug therapy will be evaluated using CTCAE version 4.0. | — |
Countries
Austria
Contacts
Public ContactKoordinierungszentrum f. Kli. Stud.
Medical University of Graz
Outcome results
None listed