Study Evaluating the Safety and Tolerability of Weekly Dosing of Oral IXAZOMIB in Adult Patients With Relapsed and Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to determine the safety profile, tolerability, and maximum tolerated dose of ixazomib citrate (MLN9708) when taken orally on a weekly dosing schedule by patients with relapsed and refractory multiple myeloma (RRMM). Secondary objectives include pharmacokinetics and response rates.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Citric Acid; Glycine; Ixazomib; Proteasome Inhibitors

Criteria

Inclusion Criteria:

Each patient must meet all of the following eligibility criteria to be enrolled in the study:

• Adult patients with multiple myeloma who have relapsed following at least 2 lines of therapy.

• Patients must have measurable disease.

• Appropriate functional status, including the recovery from the effects of prior antineoplastic therapy, and acceptable organ function as described in the protocol.

• Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.

• Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.

• Willing and able to give written informed consent.

• Suitable venous access for study-required blood sampling.

Exclusion Criteria:

• Peripheral neuropathy that is greater or equal to Grade 2.

• Major surgery or, serious infections, or infections that required systemic antibiotic therapy within 14 days before the first dose of study drug.

• Life-threatening illness unrelated to cancer.

• Diarrhea that is greater than Grade 1 as outlined in the protocol

• Systemic antineoplastic or radiation therapy within 14 days or cytotoxic agents, or treatment with any investigational products within 21 days before the first dose of study treatment.

• Treatment with any investigational proteasome inhibitor.

• Systemic treatment with prohibited medications that are outlined in the protocol within 14 days of study treatment.

• Ongoing therapy with corticosteroids greater than 10mg of prednisone or its equivalent per day.

• Central nervous system involvement.

• Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.

• Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.

• Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.

• Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption of tolerance of IXAZOMIB including difficulty swallowing.