Evaluation of Votrient in Angiosarcoma (EVA)
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Angiosarcoma | Drug: Pazopanib + Paclitaxel | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Pazopanib + Paclitaxel |
Drug: Pazopanib + Paclitaxel
pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma. |
- Rate of progression-free survival [ Time Frame: 6 Month ]Rate of progression-free survival after 6 months
- 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
- 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.
- 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

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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:
- 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

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
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 |
Principal Investigator: | Peter Hohenberger, MD | Universitätsmedizin Mannheim / Heidelberg University |
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 |
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 |