A Study of IXAZOMIB in Adult Patients With Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: IXAZOMIB
Intervention description: Patients will be administered IXAZOMIB by IV on Days 1, 8, and 15 of a 28-day cycle. The first stage of the study will be initiated at a starting dose of 0.125 mg/m2. Subsequent doses will increase until a maximum tolerated dose (MTD) is established.
Intervention MeSH terms: Ixazomib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is an open-label, multicenter, phase 1, dose-escalation study of IXAZOMIB in adult
      patients with lymphoma. This study will be the first to administer IXAZOMIB to patients with
      lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients 18 years or older.

          2. Eastern Cooperative Oncology Group performance status 0-2.

          3. Patients must have a confirmed diagnosis of lymphoma that is relapsed and/or
             refractory after at least 2 prior chemotherapeutic regimens and for which no curative
             option exists. Patients with Waldenstrom's macroglobulinemia are not eligible for
             enrollment in this study. Patients with Hodgkin lymphoma are considered eligible for
             this study.

          4. Suitable venous access for PK and pharmacodynamic evaluations.

          5. 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 to practice 2 effective methods of contraception or abstain
             from heterosexual intercourse.

          6. Voluntary written consent must be obtained.

          7. Adequate blood and chemistry values during the screening period:

               -  Absolute neutrophil count (ANC) ≥ 1,500/mm3; platelet count ≥ 100,000/mm3.

               -  Total bilirubin must be ≤ 1.5 × the upper limit of the normal range upper limit
                  of normal (ULN).

               -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be ≤ 2.5
                  × the upper limit of normal (ULN). AST and ALT may be elevated up to 5 times the
                  upper limit of normal if their elevation can be reasonably ascribed to the
                  presence of metastatic disease.

               -  Calculated creatinine clearance ≥ 30 mL/minute.

        Exclusion Criteria:

          1. Peripheral neuropathy ≥ Grade 2.

          2. Female patients who are lactating or have a positive serum pregnancy test during the
             screening period .

          3. Major surgery within 14 days before the first dose of treatment.

          4. Infection requiring systemic antibiotic therapy or other serious infection within 14
             days before the first dose of study treatment.

          5. Life-threatening illness unrelated to cancer.

          6. Diarrhea > Grade 1 based on the NCI CTCAE categorization.

          7. Systemic antineoplastic therapy/or radiotherapy within 21 days before the first dose
             of study treatment.

          8. Systemic treatment with prohibited medications.

          9. Patient has symptomatic brain metastases.

         10. Evidence of current uncontrolled cardiovascular conditions, including cardiac
             arrhythmias, congestive heart failure (CHF), angina, or myocardial infarction within
             the past 6 months.

         11. QTc > 470 milliseconds (msec) on a 12-lead electrocardiogram (ECG) obtained during the
             screening period.

         12. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C positive.

         13. Any serious medical or psychiatric illness that could, in the investigator's opinion,
             potentially interfere with the completion of treatment according to this protocol.

         14. Treatment with any investigational products within 28 days before the first dose of
             study treatment.