Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04608045
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2020-10-23
Brief Title:
Safety Dose Tolerance Pharmacokinetics and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors
Sponsor:
CicloMed LLC
Organization:
CicloMed LLC
Study Overview
Official Title:
A Phase 1 First-in-Human Safety Dose Tolerance Pharmacokinetics and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The expansion study is a Phase I multicenter open label feasibility trial to characterize the pharmacologic activity of IV CPX-POM in bladder tumor tissues obtained from patients with MIBC Stage T2 N0-N1 M0 who will be scheduled for RC with bilateral standard or extended pelvic lymph node dissection PLND
The Dose Escalation study was a Phase I multicenter open label dose escalation study to evaluate the DLTs and MTD and to determine the recommended Phase 2 dose RP2D of CPX-POM administered IV in patients with any histologically- or cytologically-confirmed solid tumor type and was completed
The Dose Escalation study was a Phase I multicenter open label dose escalation study to evaluate the DLTs and MTD and to determine the recommended Phase 2 dose RP2D of CPX-POM administered IV in patients with any histologically- or cytologically-confirmed solid tumor type and was completed
Detailed Description:
The expansion cohort of this study will be conducted at up to 3 study sites It will be an open-label feasibility trial to characterize the pharmacologic activity of IV CPX-POM in bladder tumor tissues obtained from patients with MIBC Stage T2 N0-N1M0 who will be scheduled for RC with bilateral standard or extended pelvic lymph node dissection PLND Approximately half of the patients enrolled will be cisplatin eligible and half will be chemotherapy eligible and scheduled to receive neoadjuvant chemotherapy with gemcitabine cisplatin Neoadjuvant treatment with CPX-POM whether alone or in combination with gemcitabine cisplatin will start within 8 weeks of transurethral resection of the bladder tumor TURBT that showed muscularis propria invasion
Approximately 12 patients will be enrolled Patients who are cisplatin eligible will be treated with two 21-day treatment cycles of CPX-POM Cycle 1 Days 1-5 treatment rest days 6-21 Cycle 2 Days 22-26 treatment rest days 27-43 before a planned RC Chemotherapy-eligible patients who are scheduled to receive neoadjuvant chemotherapy gemcitabine cisplatin in three 21-day treatment cycles will be treated in addition with three 21-day treatment cycles of CPX-POM Cycle 1 Days 1-5 treatment rest days 6-21 Cycle 2 Days 22-26 treatment rest days 27-42 Cycle 3 Days 43-47 rest days 48-63 ie concurrently with the prescribed chemotherapy The cisplatin gemcitabine dosing regimen for chemotherapy-eligible patients in the Expansion Cohort will be administered per the institutions standard of care After each infusion of CPX-POM patients will remain in the clinic for at least a 1-hour observation period On Day 1 of Cycle 1 single blood and clean catch urine samples will be collected prior to the first CPX-POM infusion
Approximately 12 patients will be enrolled Patients who are cisplatin eligible will be treated with two 21-day treatment cycles of CPX-POM Cycle 1 Days 1-5 treatment rest days 6-21 Cycle 2 Days 22-26 treatment rest days 27-43 before a planned RC Chemotherapy-eligible patients who are scheduled to receive neoadjuvant chemotherapy gemcitabine cisplatin in three 21-day treatment cycles will be treated in addition with three 21-day treatment cycles of CPX-POM Cycle 1 Days 1-5 treatment rest days 6-21 Cycle 2 Days 22-26 treatment rest days 27-42 Cycle 3 Days 43-47 rest days 48-63 ie concurrently with the prescribed chemotherapy The cisplatin gemcitabine dosing regimen for chemotherapy-eligible patients in the Expansion Cohort will be administered per the institutions standard of care After each infusion of CPX-POM patients will remain in the clinic for at least a 1-hour observation period On Day 1 of Cycle 1 single blood and clean catch urine samples will be collected prior to the first CPX-POM infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None