Study on Efficacy and Tolerability of Vorinostat in Patients With Advanced, Metastatic STS
Information source: University of Heidelberg
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Soft Tissue Sarcoma
Intervention: Vorinostat (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: University of Heidelberg Official(s) and/or principal investigator(s):
Gerlinde Egerer, MD, Study Director, Affiliation: Department of Internal Medicine V, Universtity Hospital Heidelberg
Overall contact:
Gerlinde Egerer, MD, Phone: +49 06221 56, Ext: 8002, Email: Gerlinde.Egerer@med.uni-heidelberg.de
Summary
Primary objective of the study is to investigate the efficacy of vorinostat in patients
suffering from selected histological types of soft tissue sarcoma. Further evaluations
relate to the safety and tolerability of vorinostat, its pharmacokinetics (course of plasma
concentration over time) and pharmacodynamics (mode of action). Only subjects with advanced,
metastatic disease will be included in this trail.
Clinical Details
Official title: A Phase II Study to Investigate the Efficacy and Tolerability of Vorinostat in Patients Suffering From Advanced, Metastatic Soft Tissue Sarcoma
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Evaluation of the efficacy of vorinostat on the basis of progression free survival (PFS) up to 1 year after first administration of the IMP.
Secondary outcome: Evaluation of the efficacy of vorinostat on the basis of overall survival up to 1 year after first administration of the IMP.
Investigation on pharmacokinetics und pharmacodynamics of vorinostat.
Evaluation of safety and tolerability of vorinostat.
Detailed description:
The treatment with vorinostat will be administered daily over 28 days. This period will be
referred to as a therapy cycle. Two consecutive therapy cycles will be separated by a 7-days
therapy break. In case of a good response and no relevant side effects, the treatment with
vorinostat can be continued for up to 1 year after begin of the treatment. If any relevant
side effects or intolerability occur, the dose and/or schedule of administration will be
modified according to the pre-defined criteria.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients with verified, metastatic soft tissue sarcoma of the following histologies:
- undifferentiated highgrade pleomorphic sarcoma/pleomorphic malignant fibrous
histiocytoma,
- undifferentiated pleomorphic sarcoma with grand cells/grand cell fibrotic
histiocytoma,
- undifferentiated pleomorphic sarcoma with prominent inflammation/inflamed MFH,
- myxofibrosarcoma,
- liposarcoma,
- synovial sarcoma,
- rhabdomyosarcoma (pleomorph, alveolar und embryonal),
- leiomyosarcoma,
- adult fibrosarcoma,
- angiosarcoma,
- malignant hemangiopericytoma/ malignant solitaire fibrous tumor,
- malignant peripheral neurilemma tumor,
- extraskeletal mesenchymal chondrosarcoma,
- extraskeletal myxoid chondrosarcoma,
- undifferentiated sarcoma of non other specified (NOS) type.
2. Verified relapse or disease progression at study inclusion, i. e. therapeutic failure
of the first line therapy with anthracyclines,
3. Measurable disease according to the RECIST criteria,
4. Previous systemic therapy of advanced and/or metastatic disease,
5. An interval of at least 4 weeks since the last surgery, chemotherapy or radiation,
6. Age over 18,
7. Following laboratory findings:
- ANC ≥ 1. 0 x 10³/mm³,
- platelets ≥ 100. 000/mm³,
- hemoglobin ≥ 9 g/dl,
- creatinin < 1. 5 x ULN (upper limit of normal),
- AST and ALT < 2. 5 x ULN,
- total bilirubin < 1. 5 x ULN,
8. Life expectancy of at least 12 weeks,
9. Negative pregnancy test,
10. Consent for an effective contraception during and up to 6 month after the study
completion.
11. Written informed consent,
12. Ability to understand the goal and the consequences of this trial.
Exclusion Criteria:
1. Proof of the following histologies:
- gastrointestinal stromal tumor (GIST),
- malignant mesothelioma,
- neuroblastoma,
- osteosarcoma,
- 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
Locations and Contacts
Gerlinde Egerer, MD, Phone: +49 06221 56, Ext: 8002, Email: Gerlinde.Egerer@med.uni-heidelberg.de
Department of Hematology, Oncology, Rheumatology and Immunology, University Hospital Tübingen, Tübingen, Baden-Württemberg D-72076, Germany
Department of Hematology, Hemostaseology, Oncology and Stemm Cell Transplantation, Medical School Hannover, Hannover, Niedersachen D-30625, Germany
Department of Oncology, Hematology and Palliative Medicine, Marien Hospital Düsseldorf, Düsseldorf, Nordrhein-Westfalen D-40479, Germany
Additional Information
Last updated: June 10, 2009
|
