Evaluation of Votrient in Angiosarcoma

NCT02212015 | Terminated Phase 2 Results

• 1 other identifier: GISG-06
• Study Type: interventional
• Target: 26
• Locations: 2 countries
• Sites: 10

Brief Summary

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

Conditions

Angiosarcoma

Outcome Measures

Primary Outcomes (3)

• Rate of Progression-free Survival

  The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.

  6 Month

• Rate of Progression-free Survival, Subgroup 1 Analysis

  Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into cutaneous angiosarcoma versus visceral angiosarcoma The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.

  6 months

• Rate of Progression-free Survival, Subgroup 2 Analysis

  Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into primary angiosarcoma versus secondary angiosarcoma. The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.

  6 months

Secondary Outcomes (7)

• Overall Survival

  from start of treatment until death within study's actual observation time for OS (22 months).

• Overall Survival, Subgroup 1 Analysis

  from start of treatment until death within study's actual observation time for OS (22 months)

• Overall Survival, Subgroup 2 Analysis

  from start of treatment until death within study's actual observation time for OS (22 months)

• Response Rate (RR)

  determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR

• Response Rate (RR), Subgroup1 Analysis

  determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR

Study Arms (1)

Pazopanib + Paclitaxel

EXPERIMENTAL

Paclitaxel administered every 28 days at day 1, day 8 and day 15 as a 2h intravenous infusion in a dose of 70mg/m2 in combination with pazopanib in a daily oral dose of 800mg (2x400mg)

Drug: Pazopanib + Paclitaxel

Interventions

Pazopanib + Paclitaxel DRUG

pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.

Pazopanib + Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead
• Universitätsmedizin Mannheim: collaborator
• Helios Klinikum Berlin-Buch: collaborator
• University Hospital Dresden: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University Hospital, Essen: collaborator
• Hannover Medical School: collaborator
• Klinikum der Universitaet Muenchen, Grosshadern: collaborator
• Medical University of Vienna: collaborator
• Medical University of Graz: collaborator
• Medical University Innsbruck: collaborator
• Novartis Pharmaceuticals: collaborator

Study Sites (10)

Universitätsklinik Graz

Graz, Austria

Location

Universitätsklinik Wien

Vienna, Austria

Location

Helios-Klinikum Bad Saarow

Bad Saarow, Germany

Location

Helios Klinikum Berlin-Buch

Berlin, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

University Medical Center

Mannheim, Germany

Location

Klinikum der Universität München Campus Großhadern

München, Germany

Location

Related Links

• German Interdisciplinary Sarcoma Group
• Sarcoma Platform Austria

MeSH Terms

Conditions

Hemangiosarcoma

Interventions

pazopanib; Paclitaxel

Condition Hierarchy (Ancestors)

Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Prof. Dr. med. Peter Hohenberger
• Organization: Universität Heidelberg/Universitätsmedizin Mannheim

peter.hohenberger@umm.de

+49 0621 383 2609

Study Officials

• Peter Hohenberger, MD

  Universitätsmedizin Mannheim / Heidelberg University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: August 8, 2014
• Study Start: July 1, 2014
• Primary Completion: December 31, 2019
• Study Completion: July 1, 2020
• Last Updated: March 22, 2022
• Results First Posted: March 22, 2022

Record last verified: 2022-01

Locations

DE (8); AU (2)