Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613217
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Study of Oral PCLX-001 in RR Acute Myeloid Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Study of Oral PCLX-001 in RelapsedRefractory RR Acute Myeloid Leukemia AML
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 dose-finding study of oral zelenirstat PCLX-001 in patients with RR AML There are two parts to the study Dose Escalation and Dose Expansion
Detailed Description:
This is a dose-finding study of oral PCLX-001 in patients with RR AML There are two parts to the study Dose Escalation and Dose Expansion
Dose Escalation will determine the minimum safe and biologically-effective dose of daily oral PCLX-001 in patients with RR AML The Bayesian optimal interval BOIN design will be used for dose escalation informed by real-time assessment of safety efficacy PK and PD in each dose cohort A maximum of 15 patients will enroll in the dose escalation part Oral PCLX-001 will be provided as continuous daily dosing on a 28-day cycle The starting dose will be 40 mg AML patients will be evaluated for toxicity PK and the relationship between PK observed in this AML trial with universally co-administered CYP3A inhibitor drugs as in this setting azole antifungals are continuously administered to this population in comparison with PK data derived from patients with NHL and solid tumors without co-administered CYP3A inhibitors These data will be integrated to inform the decision on the minimum safe and biologically-effective dose to be used in the expansion cohort
PCLX-001 will be administered as an oral daily dose on a 28-day cycle as per the dose level schedule below
Dose Escalation Schedule 1 cycle 28 days
1 Daily oral dose of 40mg
2 Daily oral dose of 70mg
3 Daily oral dose of 100mg
4 Daily oral dose of 140mg
5 Daily oral dose of 210mg
6 Daily oral dose of 280mg
Trial will start at 40mg based on results from an ongoing independent dose escalation trial in NHL and solid tumors If DLT is not observed at the dose of 280 mg this dose will be considered the minimum safe and biologically-effective dose to be used in the expansion cohort
Dose expansion 20 evaluable patients will be accrued and treated with the minimum safe and biologically-effective dose PCLX-001 will be administered as an oral daily dose on a 28-day cycle to determine the safety and preliminary clinical activity of PCLX-001
Dosing Administration PCLX-001 will be administered orally once daily on 28-day cycles at the same time each day
Dose Escalation will determine the minimum safe and biologically-effective dose of daily oral PCLX-001 in patients with RR AML The Bayesian optimal interval BOIN design will be used for dose escalation informed by real-time assessment of safety efficacy PK and PD in each dose cohort A maximum of 15 patients will enroll in the dose escalation part Oral PCLX-001 will be provided as continuous daily dosing on a 28-day cycle The starting dose will be 40 mg AML patients will be evaluated for toxicity PK and the relationship between PK observed in this AML trial with universally co-administered CYP3A inhibitor drugs as in this setting azole antifungals are continuously administered to this population in comparison with PK data derived from patients with NHL and solid tumors without co-administered CYP3A inhibitors These data will be integrated to inform the decision on the minimum safe and biologically-effective dose to be used in the expansion cohort
PCLX-001 will be administered as an oral daily dose on a 28-day cycle as per the dose level schedule below
Dose Escalation Schedule 1 cycle 28 days
1 Daily oral dose of 40mg
2 Daily oral dose of 70mg
3 Daily oral dose of 100mg
4 Daily oral dose of 140mg
5 Daily oral dose of 210mg
6 Daily oral dose of 280mg
Trial will start at 40mg based on results from an ongoing independent dose escalation trial in NHL and solid tumors If DLT is not observed at the dose of 280 mg this dose will be considered the minimum safe and biologically-effective dose to be used in the expansion cohort
Dose expansion 20 evaluable patients will be accrued and treated with the minimum safe and biologically-effective dose PCLX-001 will be administered as an oral daily dose on a 28-day cycle to determine the safety and preliminary clinical activity of PCLX-001
Dosing Administration PCLX-001 will be administered orally once daily on 28-day cycles at the same time each day
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