Study of MLN8237 in Participants With Advanced Hematological Malignancies

Status Completed

Clinical Trial Summary

This is an open-label, multicenter, phase 1 study of MLN8237 in participants with advanced hematological malignancies for whom there are limited standard treatment options.

Clinical Trial Description

The drug being tested in this study is called alisertib. Alisertib is being tested to treat people who have advanced hematological malignancies. This study determined the dose-limiting toxicity, maximum tolerated dose, safety and pharmacokinetics (how the drug moves through the body) for alisertib when given once or twice a day for 7 to 21 days.

This open label study enrolled 58 patients. Participants were enrolled in one of 3 treatment groups:

- Part 1: Powder-in-Capsule (PIC) Dose Escalation (alisertib 25 mg PIC, orally twice daily [BID] on Day 1 [loading dose] and then alisertib 25 or 35 mg PIC once daily [QD] for 21 days (D), or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14D) in 28-day cycles

- Part 1: Enteric-coated Tablet (ECT) Dose Escalation (alisertib 40 mg, ECT, orally, QD for 14D or alisertib 30, 40 or 50 mg, orally, BID for 7D) in 28-day cycles

- Part 2: Participants with Peripheral T-cell Lymphoma (PTCL) (alisertib 50 mg ECT, orally, BID for 7D) in 21-day cycles

All participants received treatment for 12 months or until their disease progressed or they experienced unacceptable alisertib-related toxicity. This multi-center trial was conducted in the United States. The overall time to participate in this study was 422 days. Participants made multiple visits to the clinic, including a final visit 30 days after receiving their last dose of alisertib for a follow-up assessment. ;

Study Design

Related Conditions & MeSH terms

Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
B-Cell Chronic Lymphocytic Leukemia
B-cell Follicular Lymphoma
B-cell Mantle Cell Lymphoma
B-cell Marginal Zone Lymphoma
B-cell Small Lymphocytic Lymphoma
Diffuse Large B-cell Lymphoma
Enteropathy Associated T-cell Lymphoma
Enteropathy-Associated T-Cell Lymphoma
Intestinal Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Mantle-Cell
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Multiple Myeloma
NK Lymphoma
Noncutaneous Peripheral T-cell Lymphoma Not Otherwise Specified
Waldenstrom Macroglobulinemia
Waldenstrom's Macroglobulinemia

Clinical Trial Details

NCT number	NCT00697346
Study type	Interventional
Source	Takeda
Contact
Status	Completed
Phase	Phase 1
Start date	July 11, 2008
Completion date	October 19, 2016

View Details

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