drugset / Trial / NCT02780011
Alsertib (MLN8237) and Brentuximab Vedotin for Relapsed/Refractory CD30-Positive Lymphomas and Solid Malignancies
Phase 1
Withdrawn
Eric Bernicker, MD
Millennium Pharmaceuticals, Inc. · collabThe Methodist Hospital Research Institute · collab
NaSingle-groupOpen-labelTreatment
Summary
This is an open label phase I trial designed to evaluate the maximum tolerated dose, dose-limiting toxicities, pharmacokinetics, and activity of the combination of alsertib (MLN8237) and brentuximab vedotin in patients with relapsed/refractory CD30-positive lymphomas and solid malignancies. Cohorts of 3-6 patients will receive escalating or de-escalating doses of MLN8237 based on a 3 + 3 design.
Timeline
- Start
- 2015-12
- Primary completion
- 2018-09
- Completion
- 2018-09
Outcome
Outcome not reported
Stopped (Business): “lack of funding”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alsertib | Unknown | 40 mg | Oral |
| Subject | Alsertib | Unknown | 60 mg | Oral |
| Subject | Alsertib | Unknown | 80 mg | Oral |
| Subject | Alsertib | Unknown | 100 mg | Oral |
| Subject | Brentuximab Vedotin | Monoclonal antibody | 1.8 mg/kg | Intravenous |