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Tyrosine Kinase Inhibitor

Bemcentinib + Pacritinib for Lung Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

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

Must have

Patients with histologically-or cytologically confirmed diagnosis of locally advanced and/or metastatic lung adenocarcinoma (Stage IV/AJCC Edition 8) without actionable driver mutations, who has failed at least one line of systemic treatment

Be refractory to, or intolerant of, an established therapy known to provide clinical benefit for their condition

Must not have

History of the following cardiac conditions: An acute ischemic cardiac event (e.g., myocardial infarction) or hospitalization for unstable angina within 3 months prior to first dose, Abnormal left ventricular ejection fraction on echocardiography, Uncontrolled cardiac disease, History or presence of bradycardia, Presence of any factors that increase the risk for QTc prolongation, Family history of long QTc syndrome or ventricular arrhythmias, Personal history of long QTc syndrome or previous drug induced QTc prolongation

Have a seizure disorder requiring anticonvulsants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment at different doses to see how safe and effective it is.

Who is the study for?

Adults with advanced lung adenocarcinoma who've failed at least one systemic treatment can join. They must have measurable disease, good organ function, no serious heart conditions or infections, and be able to swallow pills. Women of childbearing potential need a negative pregnancy test and agree to use contraception.

What is being tested?

The trial is testing the combination of two drugs, Bemcentinib and Pacritinib, for treating advanced lung adenocarcinoma. It's an early-phase study assessing dosage safety, how the body processes the drugs (pharmacokinetics), their effects on cancer (pharmacodynamics), and effectiveness.

What are the potential side effects?

Possible side effects include digestive issues like diarrhea if not controlled prior to joining; allergic reactions similar to those from sulfonamides; blood disorders due to abnormal coagulation status; fatigue from uncontrolled nonmalignant diseases; and risks associated with liver or kidney dysfunction.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is advanced, and previous treatments didn't work.

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My condition didn't improve with standard treatments.

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I am 18 years old or older.

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My liver is functioning within the required limits.

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My advanced lung cancer with a specific mutation has not improved with standard treatments.

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My kidneys work well enough, with a creatinine clearance of 30 mL/min or more.

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I am fully active or can carry out light work.

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I can swallow and tolerate pills.

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I am not pregnant or have confirmed it with a test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I take medication to control seizures.

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I have not had major surgery in the last 2 weeks.

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I do not have any serious infections that need treatment with medication.

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I haven't taken blood thinners, except for baby aspirin, in the last 14 days.

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I have had major surgery on my digestive system that affects how my body absorbs food.

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I do not have severe or uncontrolled diarrhea.

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I have HIV, hepatitis B, or hepatitis C.

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I need treatment for brain metastases within 2 weeks.

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I haven't had radiation, chemotherapy, or experimental treatments in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 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

Overall Response Rate

Progression Free Survival (PFS)

Secondary study objectives

Clinical Benefit Rate

Overall Survival (OS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase II CohortExperimental Treatment2 Interventions

Of these participants taking the Maximum tolerated dose, up to 15 will undergo a biopsy. Progression free survival will be the primary objective of this study phase.

Group II: Pharmacokinetic Phase 1b (PK) Study CohortExperimental Treatment2 Interventions

Patients will receive bemcentinib and pacritinib in combination from Days 1 to Day 28. PK samples will be collected on Day 1 (pre-dose, 4, 6h), pre-dose Day 2, Day 7 (pre-dose, 4h and 6h post-dose), pre-dose Day 8, pre-dose Day 14, and Day 22 (pre-dose and 6h post-dose) samples. The Day 22 sample will cover the steady state values for both compounds. Six dose levels of combination treatments will be considered: * Dose level -1: pacritinib 100 mg oral dose (p.o.) daily + bemcentinib 50 mg p.o. daily; * Dose level 1: pacritinib 100 mg oral dose (p.o.) twice daily (BID) + bemcentinib 50 mg p.o. daily; * Dose level 2: pacritinib 100 mg p.o. BID + bemcentinib 75 mg p.o. daily; * Dose level 3: pacritinib 100 mg BID + bemcentinib 100 mg p.o. daily; * Dose level 4: pacritinib 200 mg BID + bemcentinib 100 mg p.o. daily; * Dose level 5: pacritinib 200 mg BID + bemcentinib 125 mg p.o. daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

bemcentinib

2015

Completed Phase 2

~40

0 / 19Eligibility criteria met