Phase 2 Study of Oral IXAZOMIB in Adult Patients With Relapsed and/or Refractory Follicular Lymphoma
Conditions
Follicular Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Follicular
Conditions: Keywords
MLN9708, Lymphoma, IXAZOMIB
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: IXAZOMIB
Type: Drug
Overall Status
Recruiting
Summary
This is an open-label, multicenter, phase 2 study to evaluate the efficacy and safety of oral IXAZOMIB in adult patients with follicular lymphoma (FL) that is relapsed and/or refractory to prior treatment.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Boston, Massachusetts, United States
Status: Recruiting
New York, New York, United States
Status: Recruiting
Nashville, Tennessee, United States
Status: Recruiting
Houston, Texas, United States
Status: Not yet recruiting
Gent, Belgium
Status: Recruiting
Leuven, Belgium
Status: Recruiting
Wilrijk, Belgium
Status: Recruiting
Montreal, Quebec, Canada
Status: Recruiting
London, United Kingdom
Status: Recruiting
Manchester, United Kingdom
Status: Recruiting
Newcastle Upon Tyne, United Kingdom
Status: Recruiting
Plymouth, United Kingdom
Status: Not yet recruiting
Southampton, United Kingdom
Status: Not yet recruiting
Sutton, United Kingdom
Status: Not yet recruiting
Start Date
November 2013
Completion Date
March 2018
Sponsors
Millennium Pharmaceuticals, Inc.
Source
Millennium Pharmaceuticals, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page