Brief Title
Dose Escalation Study of MLN0128 in Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia
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
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
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
determine the dose limiting toxicities
Condition
Relapsed Multiple Myeloma
Intervention
MLN0128
Study Arms / Comparison Groups
MLN0128
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
39
Start Date
November 2010
Completion Date
July 2013
Primary Completion Date
May 2013
Eligibility Criteria
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;
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01118689
Organization ID
INK-128-002
Responsible Party
Sponsor
Study Sponsor
Millennium Pharmaceuticals, Inc.
Study Sponsor
Medical Monitor, Study Director, Millennium Pharmaceuticals, Inc.
Verification Date
July 2013