Mass Balance, Pharmacokinetics and Metabolism Study of IXAZOMIB
Condition: Advanced Solid Tumors; Lymphoma
MeSH terms: Lymphoma
Intervention: IXAZOMIB
Intervention description: Part A: Ixazomib 4.1 mg containing approximately 500-nCi [14C]-ixazomib, solution, orally on Day 1 and ixazomib 4 mg, capsule, orally on Days 14 and 21.
Part B: Ixazomib 4 mg, capsule, orally, once weekly, on Days 1, 8 and 15 in 28-day cycles until disease progression or unacceptable toxicity.
Intervention MeSH terms: Ixazomib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

        Each participant 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 participants 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 participants 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:

        Participants meeting any of the following exclusion criteria are not to be enrolled in the
        study:

          -  Female participants 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 greater than (>) 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. Participants 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 adverse events (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. Participants 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 gastrointestinal (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