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
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;