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Spots Global Cancer Trial Database for Study on Efficacy and Tolerability of Vorinostat in Patients With Advanced, Metastatic Soft Tissue Sarcoma (STS)

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Trial Identification

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

Official Title: A Phase II Study to Investigate the Efficacy and Tolerability of Vorinostat in Patients Suffering From Advanced, Metastatic Soft Tissue Sarcoma

Study ID: NCT00918489

Interventions

Vorinostat

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Department of Hematology, Oncology, Rheumatology and Immunology, University Hospital Tübingen, Tübingen, Baden-Württemberg, Germany

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

Department of Oncology, Hematology and Palliative Medicine, Marien Hospital Düsseldorf, Düsseldorf, Nordrhein-Westfalen, Germany

Comprehensive Cancer Center North, University Hospital Kiel, Kiel, , Germany

Sarcoma Center Mannheim, University Hospital Mannheim, Mannheim, , Germany

Center for Soft Tissue Sarcoma, University Hospital Tübingen, Tübingen, , Germany

Comprehensive Cancer Center Ulm (CCCU), Ulm, , Germany

Contact Details

Name: Gerlinde Egerer, MD

Affiliation: Department of Internal Medicine V, Universtity Hospital Heidelberg

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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