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A Pilot Study of Oraxol in Subjects With Cutaneous Angiosarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03544567
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Athenex, Inc.

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

Condition or disease Intervention/treatment Phase
Angiosarcoma of Skin Drug: Oraxol Phase 1

Detailed Description:

Oraxol will be administered once daily for 3 consecutive days every week during the Treatment Period 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; Oraxol may be administered from Week 26 onwards.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Oraxol in Subjects With Cutaneous Angiosarcoma
Actual Study Start Date : December 21, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Oraxol
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
oral paclitaxel will be supplied in capsules and oral HM30181A-US in tablets
Other Name: oral HM30181A + oral paclitaxel




Primary Outcome Measures :
  1. Response rate [ Time Frame: 6 months ]
    To determine the response rate 6 months after initiation of treatment with Oraxol in subjects with cutaneous angiosarcoma


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: an average of 1 year ]
    Overall safety and tolerability of Oraxol in subjects with cutaneous angiosarcoma

  2. Progression free survival [ Time Frame: 24 months ]
    To determine the progression-free survival (PFS) after initiation of treatment with Oraxol in subjects with cutaneous angiosarcoma

  3. Overall Survival (OS) [ Time Frame: 24 months ]
    To determine the overall survival (OS) after initiation of treatment with Oraxol in subjects with cutaneous angiosarcoma

  4. Duration of response [ Time Frame: 24 months ]
    To determine the duration of response in subjects with cutaneous angiosarcoma

  5. Time to best response [ Time Frame: 24 months ]
    To determine the time to best response in subjects with cutaneous angiosarcoma



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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,
      • alanine aminotransferase (ALT) ≤3×ULN, and aspartate aminotransferase (AST) ≤3×ULN,
      • gamma-glutamyl transferase (GGT) ≤10×ULN, and
      • alkaline phosphatase ≤3×ULN
  • Able to swallow pills whole and retain oral medications
  • Sexually active male subjects including men who are sterile (including vasectomy confirmed by post vasectomy semen analysis) must agree to use a condom with spermicide and to not donate sperm from the time of Screening until 6 months following the last dose of Oraxol
  • Women of non-child bearing potential due to surgical sterilization (at least 6 weeks following surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history or menopause (ie, no menstrual bleeding for more than 12 months in a woman aged ≥45 years), OR women of childbearing potential who test negative for pregnancy at time of enrollment based on serum pregnancy test must be using a highly effective method of contraception from the time of Screening until 6 months following the last dose of Oraxol. Note: Highly effective methods of contraception that result in a low failure rate (ie, <1% per year) when used consistently and correctly include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence. True abstinence, when in line with the preferred and usual lifestyle of the subject, is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of study participation and for 6 months post-Oraxol administration. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, and post-ovulation method) and withdrawal are not acceptable methods of contraception.
  • Life expectancy of at least 3 months, in the opinion of the Investigator

Exclusion Criteria:

  • 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
  • Concurrent use of a strong CYP2C8 inhibitor (eg, gemfibrozil) or inducer (eg, rifampin) within 14 days prior to treatment administration
  • Concurrent use of an oral medication with a narrow therapeutic index known to be a P-glycoprotein (P-gp) substrate within 24 hours prior to treatment administration
  • Concurrent use of a medication known to be a strong P-gp inhibitor or inducer within 14 days prior to treatment administration
  • History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity-type reaction to Cremophor® or history of hypersensitivity-type reaction to polysorbate 80 or other components of the formulation of Oraxol
  • Other severe acute or chronic medical (including bone marrow suppressive diseases) or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, impede the ability of the subject to complete all protocol-specified activities, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03544567


Contacts
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Contact: David Cutler, MD 908-290-5047 dcutler@athenex.com

Locations
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United States, Texas
Texas Oncology Recruiting
Dallas, Texas, United States, 75251
Contact: Stephanie Cannon, BS, CCRC    972-490-2939    Stephanie.Cannon@USOncology.com   
Principal Investigator: Robert Mennel, MD         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Gilberto Botello    713-792-3789    Gbotello@mdanderson.org   
Principal Investigator: Vinod Ravi, MD         
United States, Washington
University of Washington/Fred Hutchinson Cancer Center Recruiting
Seattle, Washington, United States, 98109
Contact: Roxanne Moore    206-606-6425    romoore@seattlecca.org   
Principal Investigator: Michael J. Wagner, MD         
Hong Kong
Prince of Wales Hospital, Shatin Recruiting
Hong Kong, Hong Kong
Contact    (852) 3505 2119    enquiry@clo.cuhk.edu.hk   
Principal Investigator: Herbert Loong, MD         
Taiwan
National Taiwan University Hospital Recruiting
Taipei City, Taiwan
Contact: Wei Wu Chen, MD       tomwchen@ntuh.gov.tw   
Principal Investigator: WEI-WU CHEN, MD         
Taipei Veterans General Hosptial Recruiting
Taipei City, Taiwan
Contact: Chueh Chuan Yen, MD       ccyen328@gmail.com   
Principal Investigator: CHUEH-CHUAN YEN, MD         
United Kingdom
University College London Hospitals NHS Foundation Trust Not yet recruiting
London, United Kingdom, NW1 2PG
Contact: Sandra Strauss, PhD FRCP       sandra.strauss@nhs.net   
Principal Investigator: SANDRA STRAUSS, PhD FRCP         
The Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6JJ
Contact: Robin Jones, MD    0207 352 8171    NHS.Sarcoma@rmh.nhs.uk   
Contact: Sarcoma Medsec       Sarcoma.MedsecChelsea@rmh.nhs.uk   
Principal Investigator: Robin Jones, MD         
The Christie NHS Foundation Trust, Manchester Not yet recruiting
Manchester, United Kingdom, M20 4BX
Contact: Deirdre Lehwald    +44 (0)161 918    Deirdre.Lehwald@christie.nhs.uk   
Contact: Victoria Short    +44 (0)161 918      
Principal Investigator: Michael Leahy, MD         
Sponsors and Collaborators
Athenex, Inc.
Investigators
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Study Director: David Cutler, MD Athenex, Inc.
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Responsible Party: Athenex, Inc.
ClinicalTrials.gov Identifier: NCT03544567    
Other Study ID Numbers: KX-ORAX-010
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hemangiosarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action