Dose Escalation Study of MLN0128 in Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia

Phase 1

Completed

• Conditions: Relapsed Multiple Myeloma; Refractory Multiple Myeloma; Waldenstrom Macroglobulinemia
• Interventions: Drug: MLN0128

• Registration Number: NCT01118689
• Lead Sponsor: Millennium Pharmaceuticals, Inc.

Brief Summary

The purpose of this study is to determine the safety, tolerability, maximum tolerated dose and pharmacokinetics of MLN0128 in patients with Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-05
• Study First Posted: 2010-05-07
• Study Start: 2010-11
• Primary Completion: 2013-05
• Status Verified: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-31
• Last Update Posted: 2013-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Age ≥18 years, including males and females;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
• Life expectancy of ≥3 months;
• Does not have diabetes and has normal fasting serum glucose and fasting triglycerides ≤ 300 mg/dL
• For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration;
• Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration;
• Ability to swallow oral medications;
• Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures;

Exclusion Criteria

• Have received prior cancer therapy or other investigational therapy within 2 weeks prior to the first administration of study drug.
• Known impaired cardiac function or clinically significant cardiac disease
• HIV infection;
• Failed to recover from the reversible effects of prior anticancer therapies:
• Pregnancy (positive serum or urine pregnancy test) or breast feeding;
• Malabsorption due to prior gastrointestinal (GI) surgery, GI disease;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MLN0128	MLN0128	-

Primary Outcome Measures

Name	Time	Method
determine the dose limiting toxicities	28-days