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Angiosarcoma of SkinPhase 2NCT03544567

A Study of Oraxol in Subjects With Cutaneous Angiosarcoma

A Phase 2 study testing Oraxol in people with Angiosarcoma of Skin, run by Athenex, Inc. at 10 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Angiosarcoma of Skin
What is being tested?
Oraxol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
10 sitesin 4 countries
Study dates
21 Dec 2018to 12 May 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

10 sites in 4 countries.

10 sites in 4 countries

United States4 sites

  • Texas Oncology

    Dallas, Texas, 75251

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Washington/Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

Other trials in United States

United Kingdom3 sites

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • The Christie NHS Foundation Trust, Manchester

    Manchester, M20 4BX

Other trials in United Kingdom

Taiwan2 sites

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hosptial

    Taipei

Other trials in Taiwan

Hong Kong1 site

  • Prince of Wales Hospital, Shatin

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Phase 2 Study of Oraxol in Subjects With Cutaneous Angiosarcoma

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.

Read the 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.

Being tested
Oraxol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OraxolDrug

    Also called oral HM30181A + oral paclitaxel

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

Study groups in NCT03544567
Study groupRoleWhat they receive
OraxolExperimentalOraxol 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.
Receives: Drug: Oraxol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

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

    Measured: 6 months

Secondary outcomes (6)

  1. Incidence of Treatment-Emergent Adverse Events

    Overall safety and tolerability of Oraxol in subjects with cutaneous angiosarcoma

    Measured: an average of 1 year

  2. Progression free survival

    To determine the progression-free survival (PFS) after initiation of treatment with Oraxol in subjects with cutaneous angiosarcoma

    Measured: 36 months

  3. Overall Survival (OS)

    To determine the overall survival (OS) after initiation of treatment with Oraxol in subjects with cutaneous angiosarcoma

    Measured: 36 months

  4. Duration of response

    To determine the duration of response in subjects with cutaneous angiosarcoma

    Measured: 36 months

  5. Time to best response

    To determine the time to best response in subjects with cutaneous angiosarcoma

    Measured: an average of 1 year

  6. Progression Free Rate

    To determine the progression free rate at 6 months

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2018
  2. Study start21 Dec 2018
  3. Primary completion12 May 2023
  4. Study completion12 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03544567
Sponsor's protocol ID
KX-ORAX-010
Status last verified
Jan 2023
First submitted
5 Apr 2018
Last updated
19 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oraxol in people with Angiosarcoma of Skin, run by Athenex, Inc. at 10 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, United Kingdom, Taiwan, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03544567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.

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