Study on Efficacy and Tolerability of Vorinostat in Patients With Advanced, Metastatic Soft Tissue Sarcoma (STS)

NCT00918489 | Completed Phase 2 DMC

• 1 other identifier: SAHA-I
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

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.

Conditions

Soft Tissue Sarcoma

Keywords

soft tissue sarcoma; metastatic; vorinostat

Outcome Measures

Primary Outcomes (1)

• Evaluation of the efficacy of vorinostat on the basis of progression free survival (PFS) up to 1 year after first administration of the IMP.

  Up to 1 year

Secondary Outcomes (1)

• 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

Study Arms (1)

Vorinostat

EXPERIMENTAL

Daily administration of 400mg vorinostat on 28 days (one therapy cycle). Seven days of therapy break between two consecutive cycles.

Drug: Vorinostat

Interventions

Vorinostat DRUG

Daily administration of 400mg vorinostat on 28 days (one therapy cycle). Seven days of therapy break between two consecutive cycles.

Vorinostat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• Proof of the following histologies:
• gastrointestinal stromal tumor (GIST),
• malignant mesothelioma,
• neuroblastoma,
• osteosarcoma,
• Ewing's sarcoma/PNET,
• Concurrent radio- or chemotherapy,
• 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,
• 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,
• Ejection fraction \< 40 %,
• Nursing,
• Known allergy against the IMP or drugs with similar chemical structure or additives,
• Active hepatitis B and/or C and HIV-infection

Sponsors & Collaborators

• Heidelberg University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (7)

Department of Hematology, Oncology, Rheumatology and Immunology, University Hospital Tübingen

Tübingen, Baden-Wurttemberg, D-72076, Germany

Location

Department of Hematology, Hemostaseology, Oncology and Stemm Cell Transplantation, Medical School Hannover

Hanover, Niedersachen, D-30625, Germany

Location

Department of Oncology, Hematology and Palliative Medicine, Marien Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, D-40479, Germany

Location

Comprehensive Cancer Center North, University Hospital Kiel

Kiel, 24105, Germany

Location

Sarcoma Center Mannheim, University Hospital Mannheim

Mannheim, 68167, Germany

Location

Center for Soft Tissue Sarcoma, University Hospital Tübingen

Tübingen, 72074, Germany

Location

Comprehensive Cancer Center Ulm (CCCU)

Ulm, 89081, Germany

Location

Related Publications (1)

• Schmitt T, Mayer-Steinacker R, Mayer F, Grunwald V, Schutte J, Hartmann JT, Kasper B, Husing J, Hajda J, Ottawa G, Mechtersheimer G, Mikus G, Burhenne J, Lehmann L, Heilig CE, Ho AD, Egerer G. Vorinostat in refractory soft tissue sarcomas - Results of a multi-centre phase II trial of the German Soft Tissue Sarcoma and Bone Tumour Working Group (AIO). Eur J Cancer. 2016 Sep;64:74-82. doi: 10.1016/j.ejca.2016.05.018. Epub 2016 Jun 28.

  PMID: 27367154 DERIVED

MeSH Terms

Conditions

Sarcoma; Neoplasm Metastasis

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids

Study Officials

• Gerlinde Egerer, MD

  Department of Internal Medicine V, Universtity Hospital Heidelberg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 11, 2009
• Study Start: May 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 17, 2018

Record last verified: 2018-10

Locations

DE (7)