Evaluation of Votrient in Angiosarcoma (EVA)

Heidelberg University

Status and phase: Terminated; Phase 2

Conditions: Angiosarcoma

Treatments: Drug: Pazopanib + Paclitaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02212015

GISG-06

Details and patient eligibility

About

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

Full 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).

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

26 participants in 1 patient group

Pazopanib + Paclitaxel

Experimental group

Description:

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)

Treatment:

Drug: Pazopanib + Paclitaxel