Multiple Myeloma Clinical Trial
Official title:
Phase 1/1b Pharmacokinetics Study of Oral MLN9708 in Patients With Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors With Normal Renal Function or Severe Renal Impairment
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).
The drug tested in this study was called ixazomib (MLN9708). Ixazomib was administered to
participants with cancer and either normal renal function or severe renal impairment,
including end-stage renal disease (ESRD) requiring hemodialysis. This study characterized the
PK, safety and efficacy of ixazomib.
The study enrolled 41 participants (37 multiple myeloma and 4 advanced solid tumor). The
study was conducted in 2 parts, Part A and Part B. Participants were enrolled to receive:
- Ixazomib 3.0 mg
In Part A, all participants were asked to take one 3 mg ixazomib capsule, orally on Day 1.
Participants who tolerated ixazomib in Part A had the option of continuing the study by
participating in Part B. In Part B, participants received ixazomib (4, 3, or 2.3 mg per
protocol) on Days 1, 8, and 15 of each 28-day cycle until participants experienced disease
progression or unacceptable toxicity.
This multicenter trial was conducted at 6 study sites in the United States and Canada. The
overall time to participate in this study was 435 days. Participants made multiple scheduled
visits to the clinic.
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