Trials / Completed
CompletedNCT02730481
A Study to Evaluate the Safety, Tolerability, MTD, PK, and Activity of Oraxol in Subjects w Adv. Malignancies
A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Maximum Tolerated Dose, Pharmacokinetics, and Activity of Oraxol in Subjects With Advanced Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Athenex, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, open-label, safety study. Eligible subjects will be adults with advanced malignancies. The study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline periods. The treatment phase consists of 4-week treatment periods and a follow-up period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oraxol | Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets. |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2021-03-01
- Completion
- 2021-05-01
- First posted
- 2016-04-06
- Last updated
- 2021-09-13
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02730481. Inclusion in this directory is not an endorsement.