Evaluation of Votrient in Angiosarcoma | NCT02212015

NCT02212015

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Universitätsmedizin Mannheim	OTHER
Helios Klinikum Berlin-Buch	OTHER
University Hospital Dresden	OTHER
Universitätsklinikum Hamburg-Eppendorf

Description Module

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pazopanib + Paclitaxel	Drug	pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.	Pazopanib + Paclitaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Overall Survival	Survival time of patient from start of treatment until death	from start of treatment until death within study's actual observation time for OS (22 months).
Overall Survival, Subgroup 1 Analysis

Eligibility Module

Eligibility 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

Name	Affiliation	Role
Peter Hohenberger, MD	Universitätsmedizin Mannheim / Heidelberg University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinik Graz		Graz			Austria
Universitätsklinik Wien

Label	URL
German Interdisciplinary Sarcoma Group	View source
Sarcoma Platform Austria	View source

ID	Title	Description
FG000	Pazopanib + Paclitaxel	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) in the treatment of patients with advanced or metastatic angiosarcoma.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Pazopanib + Paclitaxel	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) Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Count of Participants

Participants

6 Month

ID	Title	Description
OG000	Pazopanib + Paclitaxel	Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pazopanib + Paclitaxel	Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800 mg daily/once per day in the treatment of patients with advanced or metastatic angiosarcoma.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 28, 2016	Nov 3, 2021	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Apr 3, 2020	Nov 4, 2021	SAP_001.pdf

ID	Term
D012509	Sarcoma
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic