Oral LOXO-305 for Chronic Lymphocytic Leukemia
Recruiting at94 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Loxo Oncology, Inc.
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
This trial is testing pirtobrutinib, a tablet taken by mouth, in patients with certain types of blood cancers who haven't responded to or can't tolerate usual treatments. The medication works by blocking a protein that cancer cells need to grow. The study aims to find the best dose and see how well it works.
Research Team
DT
Donald Tsai, MD, PhD
Principal Investigator
Loxo Oncology
Eligibility Criteria
This trial is for patients with certain blood cancers like CLL/SLL or NHL who have not responded well to standard treatments or are intolerant to them. They should be in a stable condition (ECOG 0-2), able to take oral medication, and willing to use effective birth control. People can't join if they've had major surgery recently, are pregnant, on warfarin therapy, have uncontrolled infections or other serious health issues, or have been treated with pirtobrutinib before.Inclusion Criteria
I can take care of myself and am up and about more than half of the day.
I can take medication by mouth.
I have CLL/SLL, WM, or NHL and cannot tolerate at least 2 treatments or have had a BTK inhibitor.
See 6 more
Exclusion Criteria
I do not have any ongoing serious infections.
I haven't had a heart attack or uncontrolled heart issues in the last 6 months.
I have been treated with pirtobrutinib before.
See 17 more
Treatment Details
Interventions
- LOXO-305 (Bruton's Tyrosine Kinase (BTK) Inhibitor)
Trial OverviewThe study is testing LOXO-305 (pirtobrutinib) given orally. It's an open-label Phase 1/2 trial meaning everyone gets the drug and both safety and effectiveness will be studied. The participants include those who've failed previous therapies including BTK inhibitors unless it was used as first-line treatment.
Participant Groups
11Treatment groups
Experimental Treatment
Group I: Phase I Dose Escalation (Pirtobrutinib Monotherapy)Experimental Treatment1 Intervention
Dose Escalation and determination of MTD; multiple dose levels of pirtobrutinib to be evaluated
Group II: Phase 2 (Pirtobrutinib Monotherapy) Cohort 7Experimental Treatment1 Intervention
Defined as CLL/SLL or NHL not otherwise specified in Cohorts 1 through 6, inclusive of CLL/SLL, Richter's transformation, or low grade NHL with transformation, blastoid MCL, and patients with history of CNS involvement or primary CNS lymphoma. In the event the Sponsor electively closes Cohorts 2-4 prior to completion, patients with CLL/SLL who are ineligible to participate in or unable to access late phase studies of pirtobrutinib may be eligible to enroll in this cohort Diffuse large B-cell lymphoma (DLBCL) is excluded. MCL without prior BTK inhibitor treatment is excluded. Patients enrolling to Cohort 7 must have received one or more prior therapies or have no available approved therapy with demonstrated clinical benefit with the exception of untreated Richter's transformation, which is allowed.
Group III: Phase 2 (Pirtobrutinib Monotherapy) Cohort 6Experimental Treatment1 Intervention
MZL patients treated with a prior BTK inhibitor-containing regimen.
Group IV: Phase 2 (Pirtobrutinib Monotherapy) Cohort 5Experimental Treatment1 Intervention
WM patients treated with a prior BTK inhibitor-containing regimen.
Group V: Phase 2 (Pirtobrutinib Monotherapy) Cohort 4Experimental Treatment1 Intervention
CLL/SLL patients treated with prior therapy, BTK inhibitor naïve.
Group VI: Phase 2 (Pirtobrutinib Monotherapy) Cohort 3Experimental Treatment1 Intervention
CLL/SLL patients with no prior therapy.
Group VII: Phase 2 (Pirtobrutinib Monotherapy) Cohort 2Experimental Treatment1 Intervention
CLL/SLL patients treated with 2 or more prior regimens, including a BTK inhibitor-containing regimen.
Group VIII: Phase 2 (Pirtobrutinib Monotherapy) Cohort 1Experimental Treatment1 Intervention
Non-blastoid MCL patients treated with a prior BTK-inhibitor containing regimen.
Group IX: Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm BExperimental Treatment3 Interventions
Relapsed/Refractory CLL will receive the recommended Phase 2 dose of pirtobrutinib in combination with venetoclax and rituximab
Group X: Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm AExperimental Treatment2 Interventions
Relapsed/Refractory CLL will receive the recommended Phase 2 dose of pirtobrutinib in combination with venetoclax
Group XI: Phase 1 Dose Expansion (Pirtobrutinib Monotherapy)Experimental Treatment1 Intervention
Patients to receive the recommended Phase 2 dose of pirtobrutinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Loxo Oncology, Inc.
Lead Sponsor
Trials
72
Recruited
11,600+
Jacob Van Naarden
Loxo Oncology, Inc.
Chief Executive Officer since 2019
A.B. in Molecular Biology from Princeton University
Dr. Jennifer Low
Loxo Oncology, Inc.
Chief Medical Officer since 2014
MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology
Eli Lilly and Company
Industry Sponsor
Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University