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Bruton's Tyrosine Kinase (BTK) Inhibitor

Oral LOXO-305 for Chronic Lymphocytic Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Loxo Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) 0-2
Ability to receive study drug therapy orally
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new drug for people with leukemia or lymphoma who have failed other treatments.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Possible side effects of pirtobrutinib may include digestive issues, fatigue, liver problems, allergic reactions similar to past experiences with rituximab for some patients in specific arms of the trial. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of the day.
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I can take medication by mouth.
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I have CLL/SLL, WM, or NHL and cannot tolerate at least 2 treatments or have had a BTK inhibitor.
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My CLL has returned, and I haven't been treated with venetoclax before.
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I am willing to use effective birth control methods.
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My liver and kidneys are working well.
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My anemia or low platelet count improves with blood transfusions.
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My CLL has returned or didn't respond to treatment, and I haven't used venetoclax before.
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My blood counts are within a healthy range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Recommended dose for further study
To assess the preliminary anti-tumor activity of pirtobrutinib based on ORR as assessed by an Independent Review Committee (IRC).
+2 more
Secondary outcome measures
Best overall response (BOR) as assessed by the Investigator and IRC.
Duration of response (DOR) as assessed by the Investigator and IRC.
Functional Response: Change from Baseline in Physical Functioning as Measured by Physical Functioning Scale from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ)
+9 more

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Pirtobrutinib
2020
Completed Phase 1
~240
Rituximab
1999
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

Loxo Oncology, Inc.Lead Sponsor
65 Previous Clinical Trials
9,149 Total Patients Enrolled
2 Trials studying Waldenstrom Macroglobulinemia
316 Patients Enrolled for Waldenstrom Macroglobulinemia
Eli Lilly and CompanyIndustry Sponsor
2,605 Previous Clinical Trials
3,198,810 Total Patients Enrolled
4 Trials studying Waldenstrom Macroglobulinemia
414 Patients Enrolled for Waldenstrom Macroglobulinemia
Donald Tsai, MD, PhDStudy DirectorLoxo Oncology

Media Library

LOXO-305 (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03740529 — Phase 1 & 2
Waldenstrom Macroglobulinemia Research Study Groups: Phase 1 Dose Expansion (Pirtobrutinib Monotherapy), Phase 2 (Pirtobrutinib Monotherapy) Cohort 4, Phase 2 (Pirtobrutinib Monotherapy) Cohort 2, Phase 2 (Pirtobrutinib Monotherapy) Cohort 3, Phase 2 (Pirtobrutinib Monotherapy) Cohort 1, Phase 2 (Pirtobrutinib Monotherapy) Cohort 6, Phase I Dose Escalation (Pirtobrutinib Monotherapy), Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm A, Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm B, Phase 2 (Pirtobrutinib Monotherapy) Cohort 5, Phase 2 (Pirtobrutinib Monotherapy) Cohort 7
Waldenstrom Macroglobulinemia Clinical Trial 2023: LOXO-305 Highlights & Side Effects. Trial Name: NCT03740529 — Phase 1 & 2
LOXO-305 (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03740529 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still able to take in participants for this experiment?

"According to the online database clinicaltrials.gov, this study is still recruiting patients. The initial posting for the trial was on 11/16/2018, with the most recent update being on 8/15/2022."

Answered by AI

What are researchers hoping to discover through this clinical trial?

"This clinical trial, sponsored by Eli Lilly and Company, is assessing the safety of LOXO-305 in combination with venetoclax (Arm A) over a period of 24 months. The primary outcome measure will be the incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0. Additionally, the trial will evaluate secondary outcomes including the safety profile and tolerability of LOXO-305 (including acute and chronic toxicities), overall response rate (ORR), and other measures of anti-tumor activity."

Answered by AI

Are there other precedent cases for LOXO-305's efficacy?

"847 completed LOXO-305 trials originate from the National Institutes of Health Clinical Center in Rockville, Maryland. There are presently 617 ongoing clinical studies with a large number based out of Chicago, Illinois."

Answered by AI

Is this research project conducted in multiple states?

"There are a number of renowned hospitals and medical centres participating in this clinical trial, such as Northwestern University in Chicago, Smilow Cancer Hospital at Yale-New Haven in New Haven, and Scripps Coastal Medical Center in San Diego. There are 47 locations total."

Answered by AI

What are the primary purposes that LOXO-305 is taken for?

"LOXO-305 is an option for treating diffuse large b-cell lymphoma (DLBCL), B-cell lymphomas, and polyangiitis."

Answered by AI

How many people are you looking for in this clinical trial?

"That is accurate. The trial's listing on clinicaltrials.gov indicates that it is actively recruiting patients. 860 individuals are needed for the study, which has 47 different enrolment sites across the United States of America."

Answered by AI
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~0 spots leftby Apr 2024