Phase 2 Study of Oral IXAZOMIB in Adult Patients With Relapsed and/or Refractory Follicular Lymphoma

Inclusion Criteria:

- Male or female patients 18 years or older

- Patients must have a pathologically confirmed diagnosis of non-Hodgkin lymphoma (NHL)
(for the lead-in dose-finding phase) and FL (for phase 2)

- Patients must have radiographically or clinically measurable disease

- Patients must be relapsed and/or refractory after at least 1 prior therapy (excluding
radiation) with documented progressive disease at the time of enrollment

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

- Female patients who are post menopausal, surgically sterile, or agree to practice 2
effective methods of contraception or agree to practice true abstinence

- Male patients who agree to practice effective barrier contraception or agree to
practice true abstinence

- Voluntary written consent

- Suitable venous access

- Appropriate clinical laboratory values as defined in the protocol

- Recovered from toxicities of prior anticancer therapy

- If the trial proceeds to the second step on the basis of the tandem 2-step design,
patients must be confirmed PSMB1 positive at the central laboratory before treatment

Exclusion Criteria

- Peripheral neuropathy that is greater or equal to Grade 2 or Grade 1 with pain

- Female patients who are lactating and breastfeeding or have a positive serum
pregnancy test during the Screening period

- Autologous stem cell transplant within 6 months before Day 1 of Cycle 1, or prior
allogeneic stem cell transplant at any time

- Major surgery within 14 days before the first dose of study drug

- Infection requiring systemic antibiotic therapy or other serious infection within 14
days before the first dose of study drug

- Comorbid systemic illnesses or other severe concurrent disease that, in the judgment
of the investigator, would make the patient inappropriate for entry into this study
or interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens

- Evidence of current uncontrolled cardiovascular conditions including uncontrolled
hypertension, severe uncontrolled ventricular arrhythmias, unstable angina, New York
Heart Association (NYHA) Class III or IV cardiac disease, or myocardial infarction
within the past 6 months

- Diarrhea > Grade 1 on the basis of the NCI CTCAE categorization

- Systemic antineoplastic (including glucocorticoids > the equivalent of 15 mg of
prednisone daily), experimental, or radiation therapy within 21 days before the first
dose of study drug

- Prior treatment with rituximab or other unconjugated antibody treatment within 42
days (21 days if clear evidence of progressive disease or immediate treatment is
mandated)

- Treatment with radioimmunoconjugates or toxin immunoconjugates within 12 weeks before
the first dosing of study treatment

- Systemic treatment with strong inhibitors of CYP1A2 or CYP3A, or strong CYP3A
inducers within 14 days before the first dose of IXAZOMIB - Ongoing systemic therapy
with corticosteroids

- Central nervous system (CNS) involvement that is clinically uncontrolled or newly
diagnosed in the last 4 months

- Ongoing or active systemic viral infection, known human immunodeficiency virus(HIV)
positive, known active hepatitis B virus or known active hepatitis C virus

- Diagnosed or treated for another malignancy within 2 years before study enrollment or
previously diagnosed with another malignancy and have any evidence of residual
disease with the exception of nonmelanoma skin cancer or any completely resected
carcinoma in situ

- Platelet transfusions within 3 days before the 1st dose of study drug

- Inability to swallow capsules, or inability or unwillingness to avoid taking anything
by mouth except for water and prescribed medication for 2 hours before and 1 hour
after dose of IXAZOMIB - Known allergy to boron or excipients in the formulation