Trials / Completed
CompletedNCT00658970
Evaluation of KX2-391 in Patients With Advanced Malignancies
A Combined Rising Single-dose (RSD) and Rising Multiple-dose (RMD)Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of KX2-391 in Patients With Advanced Malignancies That Are Refractory to Conventional Therapies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Athenex, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this Phase 1 study is to determine the safety and tolerability of KX2-391 in cancer patients.
Detailed description
The purpose of this first in human study is to determine the safety and pharmacokinetics of KX2-391 in patients with solid tumors and lymphoma, who are refractory to conventional cancer treatments. In addition, pharmacodynamics will be evaluated using biomarkers in peripheral blood mononuclear cells and in tissue biopsy samples.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KX2-391 | 2 mg (starting dose)rising dose, oral dosing, twice daily, 21 day cycle(s); until progression or unacceptable toxicity develops |
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2010-03-01
- Completion
- 2011-05-01
- First posted
- 2008-04-16
- Last updated
- 2011-06-08
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00658970. Inclusion in this directory is not an endorsement.