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
1 other identifier
interventional
39
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2010
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2010
CompletedFirst Posted
Study publicly available on registry
May 7, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedAugust 2, 2013
July 1, 2013
2.5 years
May 5, 2010
July 31, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
determine the dose limiting toxicities
28-days
Study Arms (1)
MLN0128
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
San Francisco, California, 94143, United States
Unknown Facility
Denver, Colorado, 80218, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Hackensack, New Jersey, 07601, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Millennium Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2010
First Posted
May 7, 2010
Study Start
November 1, 2010
Primary Completion
May 1, 2013
Study Completion
July 1, 2013
Last Updated
August 2, 2013
Record last verified: 2013-07