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

A Phase I, Open Label, Dose Escalation Study of Oral Administration of Single Agent MLN0128 in Subjects With Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia

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

Study Overview

• Status: Completed
• Conditions: Waldenstrom Macroglobulinemia; Refractory Multiple Myeloma; Relapsed Multiple Myeloma
• Intervention / Treatment: Drug: MLN0128

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
  • Colorado
    • Denver, Colorado, United States, 80218
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
  • Missouri
    • St. Louis, Missouri, United States, 63110
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
  • Tennessee
    • Nashville, Tennessee, United States, 37203

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MLN0128	Drug: MLN0128; MLN0128 administered orally once daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
determine the dose limiting toxicities	28-days

Collaborators and Investigators

• Sponsor: Millennium Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: May 5, 2010
• First Submitted That Met QC Criteria: May 5, 2010
• First Posted (Estimate): May 7, 2010

Study Record Updates

• Last Update Posted (Estimate): August 2, 2013
• Last Update Submitted That Met QC Criteria: July 31, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Waldenstrom Macroglobulinemia
• Other Study ID Numbers: INK-128-002