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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 belowSelect...
I can take care of myself and am up and about more than half of the day.
Select...
I can take medication by mouth.
Select...
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:Select...
I do not have any ongoing serious infections.
Select...
I have been treated with pirtobrutinib before.
Select...
I need warfarin for blood clot treatment.
Select...
I am not taking strong medications that affect liver enzymes or drug transporters.
Select...
I don't have lasting side effects from previous treatments, except for hair loss.
Select...
I have a severe nutrient absorption problem.
Select...
I have an autoimmune blood condition that hasn't been stable in the last 4 weeks.
Select...
I haven't taken any cancer drugs or investigational agents recently.
Select...
I received targeted radiation for symptom relief within the last week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
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 moreSecondary 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 moreSide effects data
From 2022 Phase 1 trial • 32 Patients • NCT051763149%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
20 mg Rosuvastatin (Day 1)
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 6)
200 mg Pirtobrutinib QD (Days 14-17)
200 mg Pirtobrutinib QD (Days 7-12)
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 13)
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
~2200
Rituximab
1999
Completed Phase 4
~2990
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyIndustry Sponsor
2,654 Previous Clinical Trials
3,223,844 Total Patients Enrolled
Loxo Oncology, Inc.Lead Sponsor
71 Previous Clinical Trials
10,219 Total Patients Enrolled
Donald Tsai, MD, PhDStudy DirectorLoxo Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I need warfarin for blood clot treatment.I can take care of myself and am up and about more than half of the day.I can take medication by mouth.I am not taking strong medications that affect liver enzymes or drug transporters.I had a severe allergic reaction to rituximab that made me stop taking it.I haven't had a stem cell transplant or CAR-T therapy in the last 60 days.I have CLL/SLL, WM, or NHL and cannot tolerate at least 2 treatments or have had a BTK inhibitor.You cannot participate if you have HIV, and if your HIV status is unknown, a test will be done to make sure it's negative before you can join the study.I have previously been treated with venetoclax or similar medications.I have not had major surgery in the last 4 weeks.I don't have lasting side effects from previous treatments, except for hair loss.You had a serious allergic reaction to rituximab in the past.My CLL has returned, and I haven't been treated with venetoclax before.I am willing to use effective birth control methods.I have another cancer but it's in remission and I'm expected to live more than 2 years.You are allergic to any part of pirtobrutinib.I have a severe nutrient absorption problem.I have an autoimmune blood condition that hasn't been stable in the last 4 weeks.My liver and kidneys are working well.I haven't taken any cancer drugs or investigational agents recently.I received targeted radiation for symptom relief within the last week.My anemia or low platelet count improves with blood transfusions.My CLL has returned or didn't respond to treatment, and I haven't used venetoclax before.My lymphoma has spread to my brain or spinal cord, but I'm stable after treatment.My blood counts are within a healthy range.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 (Pirtobrutinib Monotherapy) Cohort 7
- Group 2: Phase 1 Dose Expansion (Pirtobrutinib Monotherapy)
- Group 3: Phase 2 (Pirtobrutinib Monotherapy) Cohort 4
- Group 4: Phase 2 (Pirtobrutinib Monotherapy) Cohort 2
- Group 5: Phase 2 (Pirtobrutinib Monotherapy) Cohort 3
- Group 6: Phase 2 (Pirtobrutinib Monotherapy) Cohort 1
- Group 7: Phase 2 (Pirtobrutinib Monotherapy) Cohort 6
- Group 8: Phase I Dose Escalation (Pirtobrutinib Monotherapy)
- Group 9: Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm A
- Group 10: Phase 1b Dose Expansion (Pirtobrutinib Combination Therapy) Arm B
- Group 11: Phase 2 (Pirtobrutinib Monotherapy) Cohort 5
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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