A Study of Oraxol in Subjects With Cutaneous Angiosarcoma

NCT03544567 | Completed Phase 2 FDA Drug

• 1 other identifier: KX-ORAX-010
• Study Type: interventional
• Target: 48
• Locations: 4 countries
• Sites: 10

Brief Summary

This is a non-blinded, multi-center, open-label, phase 2 study to evaluate the activity, safety, and tolerability of Oraxol in subjects with cutaneous angiosarcoma.

Conditions

Angiosarcoma of Skin

Outcome Measures

Primary Outcomes (1)

• Response rate

  To determine the response rate 6 months after initiation of treatment with Oraxol in subjects with cutaneous angiosarcoma

  6 months

Secondary Outcomes (6)

• Incidence of Treatment-Emergent Adverse Events

  an average of 1 year

• Progression free survival

  36 months

• Overall Survival (OS)

  36 months

• Duration of response

  36 months

• Time to best response

  an average of 1 year

Study Arms (1)

Oraxol

EXPERIMENTAL

Oraxol will be administered once daily for 3 consecutive days every week from Weeks 1 through 25. Subjects who do not have documented disease progression by the end of the Treatment Period will be eligible to receive therapy in the Treatment Extension Period; additional doses of Oraxol may be administered from Week 26 onwards. Subjects may receive Oraxol until they meet 1 of the criteria for withdrawal from the study.

Drug: Oraxol

Interventions

Oraxol DRUG

oral paclitaxel will be supplied in capsules and oral HM30181A-US in tablets

Also known as: oral HM30181A + oral paclitaxel

Oraxol

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness and ability to give informed consent, prior to any study-specific procedures and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
• Age of 18 years or older
• Histologically-confirmed cutaneous angiosarcoma that is not amenable to curative intent surgery (eg, locally advanced disease and disease for which surgical resection would carry an unacceptable risk of recurrence or morbidity to the subject)
• Subjects who have not received taxanes for the treatment of angiosarcoma
• Measurable disease per RECIST v.1.1
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• Resolution of all acute AEs resulting from prior cancer therapies to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) Grade ≤1 or to that subject's baseline
• Adequate organ function as defined by the following criteria:
• Adequate renal function as evidenced by serum creatinine ≤1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥50 mL/min per the Cockcroft and Gault formula
• Adequate bone marrow function as evidenced by:
• absolute neutrophil count (ANC) ≥1.5 × 109/L
• hemoglobin ≥9.0 g/dL (\<9.0 g/dL is acceptable if it is corrected by transfusion), and
• platelet count ≥100 × 109/L
• Adequate liver function as evidenced by
• total bilirubin within normal limits,

You may not qualify if:

• Subjects with metastases outside of local lymph node involvement
• Concurrent treatment or participation on other therapeutic clinical trial for angiosarcoma. Participation in companion studies sponsored by local institutions, including biological correlates, is permitted.
• Women who are pregnant or breastfeeding
• Receipt of systemic cytotoxic therapy, including investigational agents, within 14 days or 5 half-lives of the first study dosing day, whichever is longer
• Major surgery or trauma within 28 days prior to first dose of investigational product. Note: The following are not considered to be major procedures and are permitted before treatment administration: thoracentesis, paracentesis, catheter placement, port placement, laparoscopy, thoracoscopy, tube thoracostomy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, and imaging-guided biopsy for diagnostic purposes
• Subjects who have received wide-field radiotherapy to the pelvis ≤3 months (defined as \>50% of volume of pelvic bones or equivalent) or limited-field radiation for palliation ≤3 months prior to treatment administration. Angiosarcoma lesions in the radiation field are not evaluable unless they have developed progressive disease following radiation.
• History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
• Angina, myocardial infarction, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within 3 months prior to treatment administration
• Active bleeding or bleeding diathesis actively requiring transfusions; Note: subjects with cutaneous ulcers from angiosarcoma or who have skin lesions with bleeding are allowed to participate.
• Thrombolytic use (except to maintain IV catheters) within 10 days prior to treatment administration
• Presence of a malabsorption syndrome or major resection of the stomach or small bowel that could affect the absorption of Oraxol
• Known active viral or nonviral hepatitis or cirrhosis
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
• Active infection that requires systemic treatment
• Concurrent use of a strong cytochrome P450 (CYP) 3A4 inducer (eg, rifampin or St. John's Wort) or a strong CYP3A4 inhibitor (eg, ketoconazole) within 14 days prior to treatment administration

Sponsors & Collaborators

• Athenex, Inc.: lead

Study Sites (10)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Texas Oncology

Dallas, Texas, 75251, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Washington/Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Prince of Wales Hospital, Shatin

Hong Kong, Hong Kong

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hosptial

Taipei, Taiwan

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

The Christie NHS Foundation Trust, Manchester

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

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

Study Officials

• David Cutler, MD

  Athenex, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: June 4, 2018
• Study Start: December 21, 2018
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2); HK (1); US (4); GB (3)