Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Votrient in Angiosarcoma (EVA)

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.
 
ClinicalTrials.gov Identifier: NCT02212015
Recruitment Status : Terminated (Due to interim analysis' results and definitions fixed in protocol)
First Posted : August 8, 2014
Last Update Posted : January 22, 2021
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
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Peter Hohenberger, Universitätsmedizin Mannheim

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
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
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : July 1, 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 ]
    Rate of progression-free survival after 6 months


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: from start of treatment until death within study's actual observation time for OS (22 months). ]
    Survival time of patient from start of treatment until death

  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. Adverse Events and Serious Adverse Events [ 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



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.


Layout table for eligibility information
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


Locations
Layout table for location information
Austria
Universitätsklinik Graz
Graz, Austria
Universitätsklinik Wien
Wien, Austria
Germany
Helios-Klinikum Bad Saarow
Bad Saarow, Germany
Helios Klinikum Berlin-Buch
Berlin, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Universitätsklinikum Essen
Essen, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hannover, Germany
University Medical Center
Mannheim, Germany
Klinikum der Universität München Campus Großhadern
München, Germany
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
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Peter Hohenberger, MD Universitätsmedizin Mannheim / Heidelberg University
Additional Information:
Layout table for additonal information
Responsible Party: Peter Hohenberger, Prof. Dr. med., Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT02212015    
Other Study ID Numbers: GISG-06
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemangiosarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action