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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01118689
First received: May 5, 2010
Last updated: July 31, 2013
Last verified: July 2013

May 5, 2010
July 31, 2013
November 2010
May 2013   (final data collection date for primary outcome measure)
determine the dose limiting toxicities [ Time Frame: 28-days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01118689 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma
  • Waldenstrom Macroglobulinemia
Drug: MLN0128
MLN0128 administered orally once daily for 28 days
Experimental: MLN0128
Intervention: Drug: MLN0128
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
July 2013
May 2013   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01118689
INK-128-002
No
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP