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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00918489
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : October 17, 2018
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Gerlinde Egerer, Heidelberg University

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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Drug: Vorinostat Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Investigate the Efficacy and Tolerability of Vorinostat in Patients Suffering From Advanced, Metastatic Soft Tissue Sarcoma
Study Start Date : May 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Vorinostat

Arm Intervention/treatment
Experimental: Vorinostat
Daily administration of 400mg vorinostat on 28 days (one therapy cycle). Seven days of therapy break between two consecutive cycles.
Drug: Vorinostat
Daily administration of 400mg vorinostat on 28 days (one therapy cycle). Seven days of therapy break between two consecutive cycles.

Primary Outcome Measures :
  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. [ Time Frame: Up to 1 year ]

Secondary Outcome Measures :
  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. [ Time Frame: Up to 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00918489

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Department of Hematology, Oncology, Rheumatology and Immunology, University Hospital Tübingen
Tübingen, Baden-Württemberg, Germany, D-72076
Department of Hematology, Hemostaseology, Oncology and Stemm Cell Transplantation, Medical School Hannover
Hannover, Niedersachen, Germany, D-30625
Department of Oncology, Hematology and Palliative Medicine, Marien Hospital Düsseldorf
Düsseldorf, Nordrhein-Westfalen, Germany, D-40479
Comprehensive Cancer Center North, University Hospital Kiel
Kiel, Germany, 24105
Sarcoma Center Mannheim, University Hospital Mannheim
Mannheim, Germany, 68167
Center for Soft Tissue Sarcoma, University Hospital Tübingen
Tübingen, Germany, 72074
Comprehensive Cancer Center Ulm (CCCU)
Ulm, Germany, 89081
Sponsors and Collaborators
Heidelberg University
Merck Sharp & Dohme LLC
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Study Director: Gerlinde Egerer, MD Department of Internal Medicine V, Universtity Hospital Heidelberg
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gerlinde Egerer, Prof. Dr. med., Heidelberg University Identifier: NCT00918489    
Other Study ID Numbers: SAHA-I
First Posted: June 11, 2009    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Keywords provided by Gerlinde Egerer, Heidelberg University:
soft tissue sarcoma
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action