Pharmacokinetics Study of Oral Ixazomib (MLN9708) in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Participants With Normal Renal Function or Severe Renal Impairment
Condition: Multiple Myeloma; Advanced Solid Tumors
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Ixazomib
Intervention description: Ixazomib capsules
Intervention MeSH terms: Ixazomib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to characterize the single-dose pharmacokinetic (PK) parameters
      of ixazomib (MLN9708) in cancer participants with either normal renal function or severe
      renal impairment (RI), including participants with end-stage renal disease (ESRD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants 18 years or older

          -  Participants with multiple myeloma (MM) diagnosed according to standard criteria or
             participants with a diagnosis of an advanced malignant solid tumor for which standard,
             curative, or life prolonging treatment does not exist or is no longer effective.
             Participants with multiple myeloma must have had at least 1 prior therapy

          -  A calculated creatinine clearance (CrCl) that meets entry criteria for enrollment
             (i.e., calculated CrCl either ≥ 90 mL/min for normal renal function or < 30 mL/min for
             severe renal impairment)

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

          -  Female participants who are post menopausal, surgically sterile, or agree to practice
             2 effective methods of contraception through 90 days after the last dose of study drug
             or agree to practice true abstinence

          -  Male participants who agree to practice effective barrier contraception through 90
             after the last dose of study drug or agree to practice true abstinence

          -  Voluntary written informed consent

          -  Suitable venous access

        Exclusion Criteria:

          -  Female participants who are pregnant or lactating and breastfeeding

          -  Failure to have recovered from clinically significant effects of prior chemotherapy
             (defined as toxicity greater than Grade 1 with the exception of alopecia)

          -  Major surgery or radiotherapy within 14 days before study drug administration

          -  Dexamethasone (or equivalent systemic steroid) higher than physiologic dosing within 7
             days before study drug administration

          -  Central nervous system involvement

          -  Infection requiring IV antibiotic therapy or other serious infection within 14 days
             prior to first dose of study drug

          -  Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly,
             endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell
             leukemia, myeloproliferative syndrome, or primary amyloidosis (with the exception of
             patients in whom amyloidosis has been documented as a complication of MM, who will be
             evaluated on a case-by-case basis for trial participation)

          -  Systemic treatment with strong and moderate inhibitors of Cytochrome P1A2 (CYP1A2),
             strong and moderate inhibitors of Cytochrome P3A (CYP3A), or clinically significant
             CYP3A inducers or use of Ginkgo biloba or St. John's wort within 14 days before the
             first dose of study drug

          -  Evidence of uncontrolled cardiovascular conditions

          -  Ongoing or active infection, or known human immunodeficiency virus (HIV) positive

          -  Comorbid systemic illness or psychiatric illness that could interfere with study
             completion

          -  Known allergy to study medications

          -  Inability to swallow oral medication or condition that could interfere with oral
             absorption or tolerance of treatment