Trials / Completed
CompletedNCT01967043
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- Sponsor
- Kinex Pharmaceuticals Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a standard "3+3" Phase 1b study to determine the MTD of Oraxol (paclitaxel + HM30181 Methanesulfonate monohydrate) in subjects with advanced malignancies that may be metastatic or unresectable with measurable malignant lesion(s) per RECIST Version 1.1 criteria.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oraxol | Oraxol (Paclitaxel + HM30181AK). Paclitaxel will be supplied as 30 mg capsules and HM30181AK-US will be supplied as 15 mg tablets. |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2016-02-01
- Completion
- 2016-09-01
- First posted
- 2013-10-22
- Last updated
- 2016-12-16
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01967043. Inclusion in this directory is not an endorsement.