Status:
TERMINATED
Study of Mivavotinib (CB-659) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Lead Sponsor:
Calithera Biosciences, Inc
Conditions:
Non-GCB/ABC Diffuse Large B-Cell Lymphoma
With and Without MyD88 and/or CD79B Mutations
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
Study CX-659-401 is a multicenter, open-label, phase 2 study of mivavotinib to evaluate the single-agent activity of mivavotinib in patients with relapsed/refractory non-GCB/ABC DLBCL, incorporating c...
Detailed Description
Approximately 50 patients will be randomized 1:1 to one of two dose/schedule cohorts: one with a continuous dosing schedule (100 mg QD) and one with an induction dosing schedule (120 mg QD x 14 days, ...
Eligibility Criteria
Inclusion
- Male or female patients aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Life expectancy of \> 3 months
- Histologically confirmed de novo or transformed non-GCB DLBCL.
- Relapsed or refractory to ≥ 2 prior lines of chemotherapy based on standard of care
- Patients should not have failed more than 5 prior lines of therapy
- Must have \[18F\]Fluorodeoxyglucose-positron emission tomography (FDG-PET)-avid measurable disease that meets the size criteria per International Working Group (IWG) criteria.
- Must have recovered from adverse events of prior anti-cancer therapy to severity ≤ Grade 1.
- Adequate organ function as assessed by laboratory values.
- If female of childbearing potential, agreement to use protocol specified contraception methods. If male, agreement to use an effective barrier method of contraception.
Exclusion
- DLBCL with central nervous system (CNS) involvement with active brain or leptomeningeal disease
- Known human immunodeficiency (HIV; testing not required) or HIV-related malignancy
- Known hepatitis B surface antigen positive or known or active hepatitis C infection
- Prior autologous stem cell transplant (ASCT) or chimeric antigen receptor T-cell (CAR-T) cell infusion within 90 days of screening
- Prior allogeneic stem cell transplantation
- Unstable/inadequate cardiac function
- Known gastrointestinal (GI) disease or GI procedure that interferes with swallowing/absorption of oral drug
- Major surgery within 14 days before the first dose of study drug
- Serious infection (bacterial/fungal/viral) requiring parenteral antibiotic/antiviral therapy for \>5 days within 21 days prior to first dose of study drug
- Treatment with high-dose corticosteroids for anticancer purposes within 7 days before the first dose of mivavotinib.
- Use of medication known to be inhibitors or inducers of P-glycoprotein (P-gp) and/or Cytochrome P (CYP)3A
- Female patients who are pregnant, lactating or breastfeeding.
- Any radiation therapy within 3 weeks prior to first dose of study treatment.
- Systemic anticancer treatment within 3 weeks before first dose of study treatment
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05319028
Start Date
June 23 2022
End Date
February 24 2023
Last Update
April 4 2023
Active Locations (7)
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1
Northwestern University
Evanston, Illinois, United States, 60208
2
Henry Ford Health
Detroit, Michigan, United States, 48202
3
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
4
Toledo Clinic Cancer Center
Toledo, Ohio, United States, 43623