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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
BTK Inhibitor
Pirtobrutinib
Phase
3
Not Enrolling
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Investigator’s Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor-Naïve Mantle Cell Lymphomaa
Related Resources:
Molecule Overview Trial Enrollment
NCT04662255 show modal icon
Key Inclusion Criteria
  • Confirmed mantle cell lymphoma (MCL) diagnosis that has been previously treated with at least one prior line of systemic therapy
  • Measurable disease per Lugano criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Absolute neutrophil count ≥0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening
  • Hemoglobin ≥8 g/dL and platelets ≥50 × 109/L not requiring transfusion support or growth factors within 7 days of screening
  • AST and ALT ≤3.0 x upper limit of normal (ULN); total bilirubin ≤1.5 x ULN
  • Creatinine clearance of ≥30 mL/min according to Cockcroft-Gault formula
Key Exclusion Criteria
  • Prior treatment with an approved or investigational BTK inhibitor
  • History of bleeding diathesis
  • History of stroke or intracranial hemorrhage within 6 months of randomization
  • History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within 60 days of randomization
  • Clinically significant cardiovascular disease
  • Prolonged QT interval corrected using Fridericia's formula (QTcF) >470 ms on two out of three consecutive ECGs, and mean QTcF >470 ms on all three ECGs
  • Known HIV infection or active HBV, HCV, or CMV infections
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption
  • Ongoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers, which cannot be stopped within 3-5 half-lives of the CYP3A inhibitor therapy prior to start of study treatment
  • Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist
  • Vaccination with live vaccine within 28 days prior to randomization
a
This clinical trial is being conducted globally.
b
Administered at 200 mg orally QD until therapy discontinuation.
c
Administered at 560 mg orally QD.
d
Administered at 100 mg orally BID.
e
Administered at 160 mg orally BID or 320 mg orally QD.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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