NCT00697346

Study of MLN8237 in Participants With Advanced Hematological Malignancies

An Open-label, Phase 1 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Patients With Advanced Hematological Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Alisertib	Alisertib (MLN8237) PIC or ECT

Timeline

• Start date: 2008-07-11
• Primary completion: 2016-10-01
• Completion: 2016-10-19
• First posted: 2008-06-13
• Last updated: 2019-05-31
• Results posted: 2019-05-31

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study