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

• Sponsor: Millennium Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01118689
• Collaborator: (none)
• Enrollment: 39
• Locations: 6
• Arm: 1
• Duration (Months): 32
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Relapsed Multiple Myeloma; Refractory Multiple Myeloma; Waldenstrom Macroglobulinemia	Drug: MLN0128	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. determine the dose limiting toxicities [28-days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		San Francisco	California	United States	94143
2		Denver	Colorado	United States	80218
3		Boston	Massachusetts	United States	02115
4		St. Louis	Missouri	United States	63110
5		Hackensack	New Jersey	United States	07601
6		Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• Millennium Pharmaceuticals, Inc.

Investigators

• Study Director: Medical Monitor, Millennium Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Millennium Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT01118689
• Other Study ID Numbers: INK-128-002
• First Posted: May 7, 2010
• Last Update Posted: Aug 2, 2013
• Last Verified: Jul 1, 2013

• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Waldenstrom Macroglobulinemia

Study Results

No Results Posted as of Aug 2, 2013