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Tyrosine Kinase Inhibitor

Pharmacokinetic Phase 1b (PK) Study Cohort 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
1. Patients with histologically-or cytologically confirmed diagnosis of locally advanced and/or metastatic lung adenocarcinoma (Stage IV/AJCC Edition 8) (any PD-L1 status) without actionable driver mutations, who has failed at least one line of systemic treatment. Patients with locally advanced and/or metastatic lung adenocarcinoma with driver mutation who have failed standard targeted therapies can also be enrolled on this study.
2. Be refractory to, or intolerant of, an established therapy known to provide clinical benefit for their condition. Patients can be eligible for study if they have failed at least one line of treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights

Summary

This is a Phase Ib/II, open-label, single institution dose-escalation, safety, pharmacokinetics, pharmacodynamic and efficacy study.

Eligible Conditions
  • Lung Cancer

Eligibility Criteria

Inclusion Criteria

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

Timeline

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)

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

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
466 Previous Clinical Trials
92,044 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,820 Previous Clinical Trials
40,993,342 Total Patients Enrolled
~29 spots leftby Sep 2027
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