Trials / Completed
CompletedNCT03544567
A Study of Oraxol in Subjects With Cutaneous Angiosarcoma
A Phase 2 Study of Oraxol in Subjects With Cutaneous Angiosarcoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Athenex, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oraxol | oral paclitaxel will be supplied in capsules and oral HM30181A-US in tablets |
Timeline
- Start date
- 2018-12-21
- Primary completion
- 2023-05-12
- Completion
- 2023-05-12
- First posted
- 2018-06-04
- Last updated
- 2023-05-19
Locations
10 sites across 4 countries: United States, Hong Kong, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03544567. Inclusion in this directory is not an endorsement.