Hormone refractory prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer
Conditions
Interventions
Product Name: DTS-201
Product Code: DTS-201
Pharmaceutical Form: Powder for infusion*
Current Sponsor code: DTS-201
Other descriptive name: N-(Succinyl-ß-alanyl-L-leucyl-L-alanyl-L-leucyl) doxorubicin
Sponsors
Diatos S.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male patients =18 years. 2. Performance status Karnofsy = 70%. 3. Life expectancy > 3 months. 4. Histologically documented adenocarcinoma of the prostate. 5. Patient with one prior line of chemotherapy only. 6. Patients should have documented progression of disease. Disease progression should meet at least one of the following criteria: a. Prostate spectific antigen (PSA) evidence of progressive prostate cancer during or within 60 days of cessation of first-line chemotherapy consists of a PSA level = 5 ng/ml that has risen on = successive occasions = 2 weeks apart. b. Progression of measurable disease as defined by response evaluation creiteria in solid tumours (RECIST) (confer Appendix 3 of the protocol). c. Progression of bone disease characterized by appearance of one or more new bone lesions. 7. Adequate castration (testosterone levels = 50 ng/dL) by orchiectomy or by luteinising-hormone releasing hormone (LHRH agonist). 8. Patients receiving bisphosphate therapy must be on stable doses with stable symptoms prior to enrolment. 9. Adequate hematological and biological functions: • Bone marrow function: Neutrophils = 1500/mm3, hemoglobin = 10g/dl, platelets = 100 000/mm3. • Hepatic function: Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous treatment with an anthracycline or mithoxantrone. 2. Radiotherapy or radioisotope therapy within 4 weeks prior to study drug treatment. 3. Anticancer therapy (chemotherapy, hormone therapy, immunotherapy or biological therapy response modifiers) within 4 weeks prior to study drug first dosing. 4. Steroid therapy within 4 weeks prior to study drug first dosing. 5. Multivitamins, Vitamin D, Calcitrol, and other alternative and food supplement must be discontinued before study registration. 6. Symptomatic brain metastasis per leptomenigeal metastasis or evidence of coed spinal compression. 7. Prior radiotherapy to more than 30% of the bone marrow. 8. Uncontrolled hypercalcemia. 9. History of other malignancies within 5 years at screening, except for adequately treated basal or squamous cell skin cancer. 10. Presence of any serious concomitant systemic disorders incompatible with the study (e.g. active infection). 11. Known positive status for human immunodeficiency virus (HIV) and/or active Hepatitis B or C. 12. Less than 4 weeks after participation to another trial. 13. Any other reason suspected by the investigator as incompatible with study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the rate of prostate specific antigen (PSA) response (= 50% decline in PSA).;Secondary Objective: - To assess safety. - To determine time to PSA progression. - To determine durationof PSA response. - To determine tumour response as per response evaluation criteria in solid tumours (RECIST) criteria. - To determine overall survival. - To assess pharmacokinetics of DTS-201. - To assess CD10 & TOP expression. ;Primary end point(s): The primary efficacy endpoint of trial is the overall tumour response based on total serum PSA value. | — |
Countries
France, Italy
Outcome results
None listed