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Small Molecule Inhibitor

LP-168 for Lymphoma

Phase 1

Recruiting

Research Sponsored by Newave Pharmaceutical Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Low-grade B-cell lymphomas as follicular Grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma.

Subject must have adequate coagulation, renal, and hepatic function, per local laboratory reference ranges at Screening as follows: Activated partial thromboplastin time (APTT) and prothrombin time (PT) not to exceed 1.5 × ULN, Calculated creatinine clearance (CrCl) ≥ 60 mL/min using 24-hour CrCl OR Cockcroft-Gault formula, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 ×ULN; Bilirubin ≤ 1.5 × ULN (except subjects with Gilbert's Syndrome, who may have a bilirubin > 1.5 × ULN, per discussion between the Investigator and the Medical Monitor).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at cycle 1: day 1, day 2, day 8, day 9, day 15, day 22, day 28; at cycle 3: day 28; at cycle 6 day 28; (each cycle is 28 days

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and works well.

Who is the study for?

This trial is for adults with certain B-cell malignancies who've had at least two prior treatments. They should have good kidney, liver, and bone marrow function and not be on strong immune system suppressants or certain other drugs. People with recent cancer therapies, significant heart ECG abnormalities, or a history of Richter's transformation can't join.Check my eligibility

What is being tested?

The study tests LP-168, an oral drug for relapsed/refractory B-cell malignancies. It's a phase I trial to see how safe it is and how the body handles it (pharmacokinetics) at different doses.See study design

What are the potential side effects?

Potential side effects of LP-168 aren't detailed here but may include typical reactions to cancer medications such as nausea, fatigue, blood count changes, and possible organ-specific inflammation based on its pharmacological class.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma is a low-grade B-cell type, such as follicular or marginal zone.

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My blood clotting, kidney, and liver functions are within normal ranges.

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I have a specific type of blood cancer and have had at least 2 treatments if it's WM, FL, MCL, DLBCL, or HCL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at cycle 1: day 1, day 2, day 8, day 9, day 15, day 22, day 28; at cycle 3: day 28; at cycle 6 day 28; (each cycle is 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at cycle 1: day 1, day 2, day 8, day 9, day 15, day 22, day 28; at cycle 3: day 28; at cycle 6 day 28; (each cycle is 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and at cycle 1: day 1, day 2, day 8, day 9, day 15, day 22, day 28; at cycle 3: day 28; at cycle 6 day 28; (each cycle is 28 days 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)

Pyruvate Kinase

Recommended Phase 2 dose (RP2D)

Secondary outcome measures

Duration of Response (DOR)

Objective Response Rate (ORR)

Progression-Free Survival (PFS)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion PhaseExperimental Treatment1 Intervention

Additional subjects will be recruited to further explore the safety, tolerability, PK, and efficacy in specific subject subgroups.

Group II: Dose Escalation PhaseExperimental Treatment1 Intervention

Three to six subjects per treatment cohort will be assigned to receive sequentially higher oral doses of LP-168 on a once or twice daily schedule for 28 days, starting at a dose of 100 mg/day.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Newave Pharmaceutical IncLead Sponsor

3 Previous Clinical Trials

210 Total Patients Enrolled

Frequently Asked Questions

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

Could you please specify how many different hospitals are participating in this trial?

"So far, four sites have begun enrolling patients for this trial. These locations are Ohio State University in Columbus, Huntsman Cancer Institute, University of Utah in Salt Lake City, and University of Cincinnati in Cincinnati."

Answered by AI

Are we still enrolling people in this clinical research?

"The clinical trial is currently recruiting patients, with the first posting on July 19th, 2021 and the most recent edit on October 10th, 2022."

Answered by AI

What are the official FDA guidelines concerning LP-168?

"While LP-168 is still in Phase 1 clinical trials and therefore has limited data supporting its safety, early signs are promising."

Answered by AI

How many people are included in the research project?

"Sixty individuals that match the pre-determined eligibility criteria are needed to enroll in this study. Those who choose to participate can do so at one of multiple sites, such as Ohio State University or Huntsman Cancer Institute."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.

2021. "Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04775745.

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