A Phase II Study to Investigate the Efficacy and Tolerability of Vorinostat in Patients Suffering From Advanced, Metastatic Soft Tissue Sarcoma
Overview
- Phase
- Phase 2
- Intervention
- Vorinostat
- Conditions
- Soft Tissue Sarcoma
- Sponsor
- Heidelberg University
- Enrollment
- 40
- Locations
- 7
- Primary Endpoint
- Evaluation of the efficacy of vorinostat on the basis of progression free survival (PFS) up to 1 year after first administration of the IMP.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
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.
Investigators
Gerlinde Egerer
Prof. Dr. med.
Heidelberg University
Eligibility Criteria
Inclusion Criteria
- •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,
Exclusion Criteria
- •Proof of the following histologies:
- •gastrointestinal stromal tumor (GIST),
- •malignant mesothelioma,
- •neuroblastoma,
- •osteosarcoma,
- •Ewing's sarcoma/PNET,
- •Concurrent radio- or chemotherapy,
- •Participation in another interventional trial within 4 weeks prior to the inclusion,
- •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,
- •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,
Arms & Interventions
Vorinostat
Daily administration of 400mg vorinostat on 28 days (one therapy cycle). Seven days of therapy break between two consecutive cycles.
Intervention: Vorinostat
Outcomes
Primary Outcomes
Evaluation of the efficacy of vorinostat on the basis of progression free survival (PFS) up to 1 year after first administration of the IMP.
Time Frame: Up to 1 year
Secondary Outcomes
- 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.(Up to 1 year)