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Anti-tumor antibiotic

Oraxol for Angiosarcoma

Phase 2
Waitlist Available
Research Sponsored by Athenex, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an average of 1 year
Awards & highlights

Study Summary

This trial will test a new cancer drug to see if it is effective and safe.

Eligible Conditions
  • Angiosarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response rate
Secondary outcome measures
Duration of response
Incidence of Treatment-Emergent Adverse Events
Overall Survival (OS)
+3 more

Side effects data

From 2018 Phase 1 trial • 28 Patients • NCT03165955
57%
Diarrhoea
57%
Neutropenia
43%
Alopecia
32%
Nausea
21%
Anaemia
18%
Alanine aminotransferase increased
18%
Aspartate aminotransferase increased
14%
Decreased appetite
14%
Neuropathy peripheral
14%
Vomiting
11%
Haemorrhoids
11%
Leukopenia
7%
Insomnia
7%
Peripheral sensory neuropathy
7%
Urinary tract infection
7%
Fatigue
7%
White blood cell count decreased
7%
Hypoalbuminaemia
7%
Hyponatraemia
7%
Dizziness
7%
Malaise
7%
Upper respiratory tract infection
7%
Blood lactate dehydrogenase increased
7%
Hypoaesthesia
7%
Abdominal pain upper
7%
Mouth ulceration
7%
Pruritus
7%
Rash maculo-papular
4%
Hepatitis acute
4%
Pneumonia
4%
Septic shock
4%
Femur fracture
4%
Infected neoplasm
4%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oraxol (Oral Paclitaxel Plus HM30181)

Trial Design

1Treatment groups
Experimental Treatment
Group I: OraxolExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HM-30181
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Athenex, Inc.Lead Sponsor
26 Previous Clinical Trials
1,920 Total Patients Enrolled
David Cutler, MDStudy DirectorAthenex, Inc.
10 Previous Clinical Trials
627 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Oraxol in Subjects With Cutaneous Angiosarcoma
2018. "A Study of Oraxol in Subjects With Cutaneous Angiosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03544567.
~8 spots leftby Apr 2025
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