Paclitaxel-Avelumab for Angiosarcoma

NCT03512834 | Unknown Phase 2 DMC

• 1 other identifier: DAUHIRB-18-052
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the efficacy of Avelumab when given in combination with paclitaxel as a first line treatment for the patients with inoperable angiosarcoma.

Conditions

Angiosarcoma Metastatic

Keywords

angiosarcoma; paclitaxel; avelumab

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  CR+PR by RECIST

  up to 6 months

Secondary Outcomes (3)

• Progression free survival

  up to 12 months

• Overall survival

  up to 12 months

• Adverse event

  up to 12 months

Study Arms (1)

Paclitaxel+Avelumab

EXPERIMENTAL

Paclitaxel combination with Avelumab for inoperable angiosarcoma

Drug: Avelumab; Drug: Paclitaxel

Interventions

Avelumab DRUG

Avelumab 10mg/kg, administered via I.V infusion over 1hour, every 2weeks until disease progression or unacceptable toxicity

Also known as: BAVENCIO

Paclitaxel+Avelumab

Paclitaxel DRUG

Paclitaxel 80mg/m2 D1,8 and 15 , administered via I.V infusion, every 4 weeks.

Also known as: TAXOL, GENEXOL, ANZATAX

Paclitaxel+Avelumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent.
• Male or female subjects aged ≥ 20 years.
• Histologically or cytologically proven metastatic or locally advanced Angiosarcoma.
• Inoperable Angiosarcoma
• Chemo-naïve patient
• ECOG performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
• Disease must be measurable with at least 1 measurable lesion by RECIST 1.1
• Adequate hematological function defined by white blood cell (WBC) count ≥ 3 × 109/L with absolute neutrophil count (ANC) ≥ 1.5 × 109/L, lymphocyte count ≥ 0.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused).
• Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal range (ULN), an aspartate aminotransferase (AST), level ≤ 2.5 × ULN, and an alanine aminotransferase (ALT) level ≤ 2.5 × ULN or, for subjects with documented metastatic disease to the liver, AST and ALT levels
• ≤ 5 × ULN.
• Adequate renal function defined by an estimated creatinine clearance \> 30mL/min according to the Cockcroft-Gault formula.
• Highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female subjects if the risk of conception exists

You may not qualify if:

• Concurrent treatment with a non-permitted drug (see Section 14)
• Prior therapy with any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody.
• Concurrent anticancer treatment within 28 days before the start of trial treatment (e.g., cytoreductive therapy, radiotherapy \[with the exception of palliative bone directed radiotherapy\], immune therapy, or cytokine therapy except for erythropoietin)
• Major surgery within 28 days before the start of trial treatment (excluding prior diagnostic biopsy)
• Use of hormonal agents within 7 days before the start of trial treatment.
• Use of any investigational drug within 28 days before the start of trial treatment.
• Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the study treatment (with the exception of patients with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to ≤ 10 mg prednisone daily). Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
• Previous malignant disease other than the target malignancy to be investigated in this trial within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ.
• Rapidly progressive disease (e.g., tumor lysis syndrome).
• Active or history of central nervous system (CNS) metastases.
• Receipt of any organ transplantation including allogeneic stem-cell transplantation.
• Significant acute or chronic infections including, among others:
• Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
• Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive).
• Active or history of any autoimmune disease (subjects with diabetes Type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies.

Sponsors & Collaborators

• Sung Yong Oh: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (1)

Sung Yong Oh

Busan, 602-715, South Korea

RECRUITING

MeSH Terms

Conditions

Hemangiosarcoma

Interventions

avelumab; Paclitaxel; genexol-PM

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

Study Officials

• SUNG YONG OH, MD

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SUNG YONG OH, MD

CONTACT

+82-51-240-2808; drosy@dau.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dong-A University Hospital

Model Details: Paclitaxel + Avelumab

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 1, 2018
• Study Start: June 1, 2018
• Primary Completion: November 1, 2022
• Study Completion: May 1, 2023
• Last Updated: July 11, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)