Overview

This trial is active, not recruiting.

Conditions advanced solid tumors, lymphoma
Treatment ixazomib
Phase phase 1
Target proteasome
Sponsor Millennium Pharmaceuticals, Inc.
Start date March 2014
End date December 2014
Trial size 7 participants
Trial identifier NCT01953783, C16016

Summary

This is a phase 1, 2-part, open-label study in 4 to 6 pharmacokinetic-evaluable patients with advanced solid tumors or lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Part A: Patients will receive a single dose of 4-mg [14C]- IXAZOMIB oral solution containing approximately 500 nCi of total radioactivity on Day 1 and remain at the clinic for 8 days. On Days 14 and 21, patients may be administered a single 4.0-mg capsule of IXAZOMIB. Patients will return to the clinic in the evening before Days 14, 21, 28, and 35 for a 24-hour overnight clinic visit. Part B: Eligible patients from Part A may continue into Part B once they have completed their Day 35 assessments in Part A. Patients may receive IXAZOMIB capsules administered orally at a dose of 4.0-mg once weekly on Days 1, 8, and 15 of 28-day cycles. Patients will continue in this study until disease progression of unacceptable toxicity.
ixazomib

Primary Outcomes

Measure
Maximum concentration (Cmax)
time frame: Days 1-8; Days 14, 21, 28 and 35
Percent urinary recovery
time frame: up to 35 days
IXAZOMIB excretion in urine
time frame: up to 35 days
Percent fecal excretion
time frame: up to 35 days
Percent of total radioactivity in urine and feces
time frame: up to 35 days
First time to maximum concentration (Tmax)
time frame: Days 1-8; Days 14, 21, 28 and 35
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
time frame: Days 1-8; Days 14, 21, 28 and 35

Secondary Outcomes

Measure
Amount of metabolites in plasma
time frame: Days 1-8; Days 14, 21, 28 and 35
Number of adverse events
time frame: From first dose of study drug through 30 days after the last dose of study drug
Amount of metabolites in urine
time frame: Days 1-8; Days 14, 21, 28 and 35
Amount of metabolites in feces
time frame: Days 1-8; Days 14, 21, 28 and 35

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Each patient must meet all of the following inclusion criteria to be enrolled in the study: - 18 years or older - Histologic or cytologic diagnosis of advanced or metastatic solid tumor or lymphoma for which no standard, curative, or life-prolonging therapies exist or are effective - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 - Female patients who are postmenopausal for at least 1 year OR are surgically sterile OR if of childbearing potential, agree to practice 2 effective methods of contraception at the same time during the entire study through 90 days after the last dose of study drug OR agree to practice true abstinence - Male patients who agree to practice effective barrier contraception during the entire study and through 90 days after the last dose of study drug OR agree to practice true abstinence - Voluntary written consent - Suitable venous access for the conduct of blood sampling - Recovered from the reversible effects of prior anticancer therapy Exclusion Criteria: Patients meeting any of the following exclusion criteria are not to be enrolled in the study: - Female patients who are lactating or breastfeeding or have a positive serum pregnancy test - Serious medical or psychiatric illness that could interfere with the study - Treatment with any investigational products or radiotherapy within 21 days before the first dose of study drug - Peripheral neuropathy > Grade 2 - Systemic treatment with strong and moderate inhibitors of CYP1A2, strong and moderate inhibitors of 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 - Symptomatic brain metastasis. Patients with brain metastases: must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks after completion of the definitive therapy; and must be without neurologic dysfunction that would confound the evaluation of neurologic and other AEs - Ongoing treatment with corticosteroids - Major surgery within the 14 days preceding the first dose of study drug - Infection requiring systemic intravenous antibiotic therapy or other serious infection within 14 days before the first dose of study drug - Life-threatening illness unrelated to cancer - Known hepatitis B surface antigen -positive, or known or suspected active hepatitis C infection or human immunodeficiency virus (HIV) positive - Diagnosed or treated for another malignancy within 2 years before the first dose, OR previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection - Any cardiovascular condition specified in the study protocol - Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of IXAZOMIB - History of urinary and/or fecal incontinence - Inability to comply with study procedures or visit schedule including the requirement for inpatient confinement

Additional Information

Official title A Phase 1 Study of [14C]- IXAZOMIB (MLN9708) to Assess Mass Balance, Pharmacokinetics, and Metabolism in Patients With Advanced Solid Tumors or Lymphomas
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Millennium Pharmaceuticals, Inc..