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Evaluation of Votrient in Angiosarcoma (EVA)

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ClinicalTrials.gov Identifier: NCT02212015
Recruitment Status : Recruiting
First Posted : August 8, 2014
Last Update Posted : October 27, 2016
Sponsor:
Collaborators:
Universitätsmedizin Mannheim
Helios Klinikum Berlin-Buch
University Hospital Dresden
Universitätsklinikum Hamburg-Eppendorf
University Hospital, Essen
Hannover Medical School
Klinikum der Universitaet Muenchen, Grosshadern
Medical University of Vienna
Medical University of Graz
Medical University Innsbruck
GlaxoSmithKline
Information provided by (Responsible Party):
Heidelberg University

Brief Summary:
Open-label phase II trial investigating the efficacy and safety of the investigational combination of pazopanib and paclitaxel.

Condition or disease Intervention/treatment Phase
Angiosarcoma Drug: Pazopanib + Paclitaxel Phase 2

Detailed Description:
Open-label phase II trial investigating the efficacy and safety of the investigational combination of pazopanib and paclitaxel.This multi-center, open-label, prospective, single arm phase II study was designed to evaluate the clinical efficacy and safety of the experimental combination of pazopanib with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.The safety evaluations (physical examination, laboratory checks as defined in protocol, toxicity/adverse event assessment according Eastern Cooperative Oncology Group version 4.0) are scheduled every cycle at day 1, 8, 15 and 29 (= day 1 of the next cycle).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-arm, Multicenter, Open Label Phase II Trial to Evaluate the Efficacy of Pazopanib in Combination With Paclitaxel in Advanced and Relapsed Angiosarcoma
Study Start Date : July 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pazopanib + Paclitaxel Drug: Pazopanib + Paclitaxel
pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.




Primary Outcome Measures :
  1. Rate of progression-free survival [ Time Frame: 6 Month ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 24 weeks after EOS of last patient ]
  2. Response rate [ Time Frame: 8 weeks during first 6 month then 12 weeks follow-up period until progression or death ]
    Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.

  3. Toxicity [ Time Frame: 30 days after EOS of last patient ]
    Number of patients in which adverse events occur during treatment according to Common Toxicity Criteria for Adverse Effects , Version 4.0



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

Inclusion Criteria:

  • Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up. Note: Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging studies) and obtained prior to signing informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
  • Age ≥ 18 years
  • Life expectancy > 3 months
  • Ability to swallow tablets
  • Histological confirmed angiosarcoma, primary and secondary angiosarcoma (e.g. radiation-induced or angiosarcoma in chronical lymphedema) are eligible.
  • Tumor must be locally advanced (unresectable) or metastatic. A progression must be documented within a 6-month period prior to screening.
  • Eastern Cooperative Oncology Group performance status ≤ 2
  • At least one measurable skin lesion or one measurable radiological (CT or MRI) target lesion (RECIST 1.1)
  • Adequate organ system function as described in protocol
  • A female is eligible to enter and participate in this study if she is either of non childbearing potential (defined in protocol) or childbearing potential with negative pregnancy test within 2 weeks prior to the first dose of study drug and agrees to use adequate contraception (as defined in protocol) during the study and for 30 days after the last dose of study drug.
  • All sexually active male patients must agree to use adequate methods of birth control (see protocol) throughout the study and for 30 days after the last dose of study drug.

Exclusion Criteria:

  • Patients who need an active treatment for another malignant disease other than angiosarcoma
  • Prior treatment with taxane within the last 12 months before study entry
  • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal sarcomatosis.(see protocol)
  • Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding (see protocol)
  • Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product (see protocol)
  • Presence of uncontrolled infection
  • QT prolongation interval (QTc) > 480 msec.
  • Clinically significant cardiovascular disorders within the past 6 months
  • Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer
  • Poorly controlled hypertension (see protocol)
  • Evidence of active bleeding or bleeding diathesis
  • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
  • Uncontrolled seizures, disorders of the CNS or psychiatric disorders which may put patient safety at risk, prevent giving informed consent or impact the patient's compliance with the use of study medication
  • Women who are pregnant or breast feeding
  • Patients who are not able or not willing to interrupt the intake of medications that are not allowed according to study protocol for at least 14 days before start of study medication and for the whole study period
  • Chemotherapy or radiotherapy within 14 days before start of study medication
  • Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity, except alopecia

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 ClinicalTrials.gov identifier (NCT number): NCT02212015


Contacts
Contact: Peter Hohenberger, MD ++49621383 ext 3433 studien@gisg.de
Contact: Annette Reichardt, MD ++49309401 ext 14852 annette.reichardt@helios-kliniken.de

Locations
Austria
Universitätsklinik Graz Recruiting
Graz, Austria
Contact: Wolfgang Eisterer, MD         
Principal Investigator: Wolfgang Eisterer, MD         
Universitätsklinikum Innsbruck Recruiting
Innsbruck, Austria
Contact: Ferdinand Ploner, MD         
Principal Investigator: Ferdinand Ploner, MD         
Universitätsklinik Wien Recruiting
Wien, Austria
Contact: Thomas Brodowicz, MD         
Principal Investigator: Thomas Brodowicz, MD         
Germany
Klinikum Berlin-Buch Recruiting
Berlin, Germany
Contact: Peter Reichardt, MD         
Contact: Daniel Pink, MD         
Principal Investigator: Peter Reichardt, MD         
Universitätsklinikum Carl Gustav Carus Recruiting
Dresden, Germany
Contact: Markus Schuler, MD         
Principal Investigator: Markus Schuler, MD         
Universitätsklinikum Essen Recruiting
Essen, Germany
Contact: Sebastian Bauer, MD         
Principal Investigator: Sebastian Bauer, MD         
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany
Contact: Nils Thoennissen, MD         
Principal Investigator: Nils Thönnissen, MD         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany
Contact: Viktor Grünwald, MD         
Principal Investigator: Viktor Grünwald, MD         
University Center Mannheim Recruiting
Mannheim, Germany
Contact: Peter Hohenberger, MD    0049621383 ext 3433    studien@gisg.de   
Contact: Bernd Kasper, MD    0049621383 ext 3433    studien@gisg.de   
Principal Investigator: Peter Hohenberger, MD         
Klinikum der Universität München Campus Großhadern Recruiting
München, Germany
Contact: Lars Lindner, MD         
Principal Investigator: Lars Lindner, MD         
Sponsors and Collaborators
Heidelberg University
Universitätsmedizin Mannheim
Helios Klinikum Berlin-Buch
University Hospital Dresden
Universitätsklinikum Hamburg-Eppendorf
University Hospital, Essen
Hannover Medical School
Klinikum der Universitaet Muenchen, Grosshadern
Medical University of Vienna
Medical University of Graz
Medical University Innsbruck
GlaxoSmithKline
Investigators
Principal Investigator: Peter Hohenberger, MD University Centre Mannheim and Heidelberg

Additional Information:
Responsible Party: Heidelberg University
ClinicalTrials.gov Identifier: NCT02212015     History of Changes
Other Study ID Numbers: GISG-06
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Hemangiosarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action