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

Refractory Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118689
• Other study ID #: INK-128-002
• Status: Completed
• Phase: Phase 1
• First received: May 5, 2010
• Last updated: July 31, 2013
• Start date: November 2010
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Refractory Multiple Myeloma
• Relapsed Multiple Myeloma
• Waldenstrom Macroglobulinemia

Intervention

Drug:
• MLN0128
MLN0128 administered orally once daily for 28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determine the dose limiting toxicities		28-days	Yes