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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
Must not have
Active uncontrolled systemic bacterial, viral, fungal or parasitic infection
Prior treatment with pirtobrutinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

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.

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.
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.
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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My CLL has returned or didn't respond to treatment, and I haven't used venetoclax before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any ongoing serious infections.
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I have been treated with pirtobrutinib before.
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I need warfarin for blood clot treatment.
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I am not taking strong medications that affect liver enzymes or drug transporters.
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I don't have lasting side effects from previous treatments, except for hair loss.
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I have a severe nutrient absorption problem.
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I have an autoimmune blood condition that hasn't been stable in the last 4 weeks.
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I haven't taken any cancer drugs or investigational agents recently.
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I received targeted radiation for symptom relief within the last week.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Side effects data

From 2022 Phase 1 trial • 32 Patients • NCT05176314
9%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
20 mg Rosuvastatin (Day 1)
200 mg Pirtobrutinib QD (Days 14-17)
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 13)
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 6)
200 mg Pirtobrutinib QD (Days 7-12)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Pirtobrutinib
2020
Completed Phase 1
~240
Venetoclax
2019
Completed Phase 3
~2240
Rituximab
1999
Completed Phase 4
~2990

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,678 Previous Clinical Trials
3,464,835 Total Patients Enrolled
4 Trials studying Waldenstrom Macroglobulinemia
414 Patients Enrolled for Waldenstrom Macroglobulinemia
Loxo Oncology, Inc.Lead Sponsor
71 Previous Clinical Trials
10,200 Total Patients Enrolled
2 Trials studying Waldenstrom Macroglobulinemia
316 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 2 (Pirtobrutinib Monotherapy) Cohort 7, 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
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
~262 spots leftby Sep 2027
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