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LOXO-338 for Blood Cancers

Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have B-cell malignancy
Patients must have received prior therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up estimated up to 2 years
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective for treating advanced blood cancer in patients who have already tried other treatments.

Eligible Conditions
  • Waldenstrom Macroglobulinemia
  • Chronic B-Cell Leukemia
  • Mantle Cell Lymphoma
  • Multiple Myeloma
  • Marginal Zone Lymphoma
  • Non-Hodgkin's Lymphoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must have a type of cancer that starts in your B-cells.
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You have received treatment before.
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You are able to perform daily activities without any major issues.
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You are expected to live for at least 12 more weeks.
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If you have AL amyloidosis, you must have a way to measure the disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~estimated up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and estimated up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 - To determine the effect of LOXO-338 on response rates
Part 1 - To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of oral LOXO-338
Part 2 - To determine the safety and tolerability of LOXO-338 when given in combination with pirtobrutinib
Secondary outcome measures
Part 1 - To assess preliminary antitumor activity of LOXO-338 based on duration of response (DOR)
Part 1 - To assess preliminary antitumor activity of LOXO-338 based on overall response rate (ORR)
Part 1 - To assess preliminary antitumor activity of LOXO-338 based on progression-free survival (PFS)
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: LOXO-338 + Pirtobrutinib (Combination)Experimental Treatment2 Interventions
LOXO-338 administered orally in combination with pirtobrutinib
Group II: LOXO-338 (Monotherapy)Experimental Treatment1 Intervention
LOXO-338 administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirtobrutinib
2020
Completed Phase 1
~240

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,605 Previous Clinical Trials
3,199,354 Total Patients Enrolled
4 Trials studying Waldenstrom Macroglobulinemia
958 Patients Enrolled for Waldenstrom Macroglobulinemia
Loxo Oncology, Inc.Industry Sponsor
65 Previous Clinical Trials
9,693 Total Patients Enrolled
2 Trials studying Waldenstrom Macroglobulinemia
860 Patients Enrolled for Waldenstrom Macroglobulinemia
James Pauff, MD; PhDStudy DirectorLoxo Oncology, Inc.

Media Library

LOXO-338 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05024045 — Phase 1
Waldenstrom Macroglobulinemia Research Study Groups: LOXO-338 (Monotherapy), LOXO-338 + Pirtobrutinib (Combination)
Waldenstrom Macroglobulinemia Clinical Trial 2023: LOXO-338 Highlights & Side Effects. Trial Name: NCT05024045 — Phase 1
LOXO-338 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05024045 — Phase 1

Frequently Asked Questions

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

Has LOXO-338 achieved regulatory authorization from the FDA?

"Considering the preliminary nature of this Phase 1 trial, LOXO-338 has been rated a '1' on our safety scale. This rating is reflective of limited data surrounding its efficacy and security."

Answered by AI

What is the sample size for this research project?

"A total of 316 eligible participants are required for the successful completion of this trial, which is being conducted by Loxo Oncology Inc. in numerous locations throughout the USA - such as City of Hope National Medical Center (Duarte, Minnesota) and Mayo Clinic (Rochester, New york)."

Answered by AI

Is access to this research currently accessible for participants?

"This medical investigation is actively seeking participants. The trial was initially posted on September 30th 2021 and the information has been recently updated as of October 11th 2022."

Answered by AI

How many sites are actively overseeing the trial?

"The medical trial is being offered to patients at City of Hope National Medical Centre in Duarte, Minnesota, Mayo Clinic located in Rochester, New york and University California San Francisco. Additionally, it's available at 12 other sites throughout the USA."

Answered by AI

What are the primary goals of this experimental endeavor?

"Per the principal investigator, Loxo Oncology, Inc., this trial's primary purpose will be evaluated within a 28-day cycle. Specifically, they aim to assess how LOXO-338 impacts response rates and preliminary antitumor activity based on time-to-progression (TTP). Additionally, secondary objectives include characterizing its pharmacokinetic properties through measuring Area Under Curve (AUC) and Maximum Drug Concentration (Cmax)."

Answered by AI
~92 spots leftby Mar 2025