Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516887
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IbII Open-Label Dose-Escalation Safety Pharmacokinetic Pharmacodynamic and Efficacy Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase IbII open-label single institution dose-escalation safety pharmacokinetics pharmacodynamic and efficacy study
Detailed Description:
Specific Aim 1 Determine the safety tolerability and maximum tolerated dose MTD of pacritinib in combination with bemcentinib in patients with advanced lung adenocarcinoma We propose a prospective open-label phase Ib trial to evaluate safety tolerability and MTD of pacritinib JAK2 inhibitor in combination with bemcentinib AXL inhibitor in patients with treatment refractory lung adenocarcinoma The primary objectives of the phase Ib study are to determine the maximum tolerated dose MTD pharmacokineticspharmacodynamics PKPD dose-limiting toxicities DLTs and efficacy of oral pacritinib in combination with bemcentinib This phase Ib part of the study will use a Bayesian Optimal Interval BOIN70 design to determine MTD This Bayesian dose-finding approach combines the ease of implementation of the traditional 33 design with the improved performance of more complex model-based designs in terms of accurately identifying the MTD Compared to the modified probability toxicity interval design it has a substantially lower risk of overdosing patients and generally has a higher probability of correctly selecting the MTD In the phase Ib part of the study subjects with advanced lung adenocarcinoma will be treated with pacritinib in combination with bemcentinib at increasing doses until MTD for combination treatment has been established Six dose levels of combination treatments will be considered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None