Status:
COMPLETED
Pharmacokinetics Study of Oral Ixazomib (MLN9708) in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Participants With Normal Renal Function or Severe Renal Impairment
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Multiple Myeloma
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 (...
Detailed Description
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 rena...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2016
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01830816
Start Date
September 16 2013
End Date
November 18 2016
Last Update
June 10 2019
Active Locations (11)
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1
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
2
Illinois Cancer Care
Peoria, Illinois, United States, 61615
3
University of Kansas Cancer Center, Clinical Research Center
Fairway, Kansas, United States, 66205
4
University of Maryland
Baltimore, Maryland, United States, 21201