Subjects suffering from advanced, metastatic soft tissue sarcoma. MedDRA version: 16.0 Level: LLT Classification code 10015838 Term: Extraskeletal chondrosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.0 Level: PT Classification code 10061527 Term: Neurofibrosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.0 Level: PT Classification code 10
Conditions
Interventions
Trade Name: Zolinza
Pharmaceutical Form: Capsule
INN or Proposed INN: vorinostat
CAS Number: 149647-78-9
Other descriptive name: SAHA
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
University Hospital Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with verified, metastatic soft tissue sarcoma of following histologies: a. Undifferentiated highgrade pleomorphic sarcoma/pleomorphic malignant fibrous histiocytoma, b. Undifferentiated pleomorphic sarcoma with grand cells/ grand cells fibrotic histiocytoma, c. Undifferentiated pleomorphic sarcoma with prominent inflammation/ inflammated MFH, d. Myxofibrosarcoma, e. Liposarcoma, f. Synovial sarcoma, g. Rhabdomyosarcoma (pleomorphic, alveolar und embryonal), h. Leiomyosarcoma, i. Adult fibrosarcoma, j. Angiosarcoma, k. Malignant haemangiopericytoma/ malignant solitaire fibrous tumor, l. Malignant peripheral neurilemma tumor, m. Extraskeletal mesenchymal chondrosarcoma, n. Extraskeletal myxoid chondrosarcoma, o. Undifferentiated sarcoma of NOS (not otherwise specified) type. 2. Verified relapse or disease progression at the study inclusion, i.e. therapeutic failure of the first line therapy with antracyclines, 3. Measurable disease according to RECIST criteria, 4. Previous systemic therapy of advanced and/or metastatic disease, 5. An interval of at least 4 weeks to the last surgery, chemotherapy or radiation, 6. Age over 18, 7. Following laboratory findings: a. ANC = 1.0 x 10³/mm³, b.Platelets = 100.000/mm³, c. haemoglobin = 9 g/dl, d. creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Proof of the following histologies: a. gastrointestinal stromal tumor (GIST), b. malignant mesothelioma, c. neuroblastoma, d. osteosarcoma, e. Ewing's sarcoma/PNET, 2. Concurrent radio- or chemotherapy, 3. Participation in another interventional trial within 4 weeks prior to the inclusion, 4. Previous therapy with another HDAC-inhibitor (e.g. depsipeptide, MS-275, LAQ-824, PXD-101 und valproic acid). Patients, who underwent a therapy with valproic acid for treatment of seizures, can be included after a wash-out period of at least 30 days, 5. Symptomatic brain metastases, that have not been treated by radiotherapy. The interval between the last radiation and the study inclusion must not be shorter than 30 days, 6. Previous malignant disease (except for a non-melanoma of the skin and a carcinoma in situ of uterus), unless in complete remission and after the last therapy for at least 5 years, 7. Ejection fraction < 40 %, 8. Nursing, 9. Known allergy against the IMP or drugs with similar chemical structure or additives, 10. Active hepatitis B and/or C and HIV-infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of progression-free survival on the basis of RECIST criteria;Secondary Objective: Investigation on: Overall survival up to 1 year after beginning of the treatment Total dose required per patient and dosing schedule Pharmacokinetics and pharmacodynamics Safety and tolerability (adverse events, pathological findings in EKG and cardiological investigation in a subpopulation included at the centre in Heidelberg);Primary end point(s): Progression-free survial | — |
Countries
Germany
Outcome results
None listed