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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01118689
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE May 5, 2010
First Posted Date  ICMJE May 7, 2010
Last Update Posted Date August 2, 2013
Study Start Date  ICMJE November 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2010)
determine the dose limiting toxicities [ Time Frame: 28-days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Escalation Study of MLN0128 in Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma
  • Waldenstrom Macroglobulinemia
Intervention  ICMJE Drug: MLN0128
MLN0128 administered orally once daily for 28 days
Study Arms  ICMJE Experimental: MLN0128
Intervention: Drug: MLN0128
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2013)
39
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2010)
56
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01118689
Other Study ID Numbers  ICMJE INK-128-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Millennium Pharmaceuticals, Inc.
Study Sponsor  ICMJE Millennium Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
PRS Account Millennium Pharmaceuticals, Inc.
Verification Date July 2013

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