AngiosarcomaPhase 2EVANCT02212015
Evaluation of Votrient in Angiosarcoma
A Phase 2 study testing Pazopanib + Paclitaxel in people with Angiosarcoma, run by Heidelberg University at 10 sites in 2 countries.
Trial summary
Open-label phase II trial investigating the efficacy and safety of the investigational combination of pazopanib and paclitaxel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angiosarcoma
- What is being tested?
- Pazopanib + Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jul 2014to 1 Jul 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Germany8 sites
Helios-Klinikum Bad Saarow
Bad Saarow
Helios Klinikum Berlin-Buch
Berlin
Universitätsklinikum Carl Gustav Carus
Dresden
Universitätsklinikum Essen
Essen
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Medizinische Hochschule Hannover
Hanover
University Medical Center
Mannheim
Klinikum der Universität München Campus Großhadern
München
About this study
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
Open-label phase II trial investigating the efficacy and safety of the investigational combination of pazopanib and paclitaxel.
Read the 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).
- Conditions
- Angiosarcoma
- Being tested
- Pazopanib + Paclitaxel
- Medical subject headings
- Hemangiosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pazopanib + PaclitaxelDrug
pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Pazopanib + Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (7)
Overall Survival
Survival time of patient from start of treatment until death
Measured: from start of treatment until death within study's actual observation time for OS (22 months).
Overall Survival, Subgroup 1 Analysis
Survival time of patients from start of treatment until death, Subgroup 1 categorizing 26 overall participants into 18 cutaneous angiosarcoma versus 8 visceral angiosarcomas
Measured: from start of treatment until death within study's actual observation time for OS (22 months)
Overall Survival, Subgroup 2 Analysis
Survival time of patients from start of treatment until death, Subgroup 2 categorizing 26 overall participants into 13 primary cutaneous angiosarcoma versus 13 secondary angiosarcomas
Measured: from start of treatment until death within study's actual observation time for OS (22 months)
Response Rate (RR)
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.
RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies
Measured: 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
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.
RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 1 which is the analysis of cutaneous angiosarcoma versus visceral angiosarcoma
Measured: 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), Subgroup 2 Analysis
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.
RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 2 which is the analysis of primary angiosarcoma versus secondary angiosarcoma
Measured: 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
Adverse Events and Serious Adverse Events
Number of patients in which adverse events occur during treatment according to Common Toxicity Criteria for Adverse Effects, Version 4.0
Measured: 30 days after EOS of last patient or end of overall study observation period (22 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startJul 2014
- Primary completion31 Dec 2019
- Study completion1 Jul 2020
Why it stopped: Due to interim analysis' results and definitions fixed in protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AngiosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Peter Hohenberger, Universitätsmedizin Mannheim
- Investigators
- Peter Hohenberger, MD, Principal investigator, Universitätsmedizin Mannheim / Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212015
- Sponsor's protocol ID
- GISG-06
- Acronym
- EVA
- Status last verified
- Jan 2022
- First submitted
- 29 Jul 2014
- Last updated
- 22 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02212015
- Acronym / sponsor ID
- EVA / GISG-06
- Conditions
- Angiosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to interim analysis' results and definitions fixed in protocol
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- 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
- Study start
- Jul 2014
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 8 Aug 2014 (estimated)
- Results
- Posted 22 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label phase II trial investigating the efficacy and safety of the investigational combination of pazopanib and paclitaxel.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pazopanib + Paclitaxel | Experimental | Drug: Pazopanib + PaclitaxelPaclitaxel 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pazopanib + Paclitaxelpazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma. | Drug | Pazopanib + Paclitaxel |
Primary outcome
Rate of Progression-free Survival
Time frame: 6 Month
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.
Rate of Progression-free Survival, Subgroup 1 Analysis
Time frame: 6 months
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.
Rate of Progression-free Survival, Subgroup 2 Analysis
Time frame: 6 months
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.
7 secondary outcomes
Overall Survival
Time frame: from start of treatment until death within study's actual observation time for OS (22 months).
Overall Survival, Subgroup 1 Analysis
Time frame: from start of treatment until death within study's actual observation time for OS (22 months)
Overall Survival, Subgroup 2 Analysis
Time frame: from start of treatment until death within study's actual observation time for OS (22 months)
Response Rate (RR)
Time frame: 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
Time frame: 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), Subgroup 2 Analysis
Time frame: 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
Adverse Events and Serious Adverse Events
Time frame: 30 days after EOS of last patient or end of overall study observation period (22 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- German Interdisciplinary Sarcoma GroupLink provided by the sponsor.
- Sarcoma Platform AustriaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Hohenberger, MD principal investigator
Universitätsmedizin Mannheim / Heidelberg University
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pazopanib + Paclitaxel in people with Angiosarcoma, run by Heidelberg University at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Progression-free Survival (time frame: 6 Month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.