Ignite Creation Date:
2024-05-06 @ 5:43 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05411679
Status:
WITHDRAWN
Last Update Posted:
2023-06-12
First Post:
2022-05-25
Brief Title:
EP0057 in Combination With Olaparib in Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer
Sponsor:
Ellipses Pharma
Organization:
Ellipses Pharma
Study Overview
Official Title:
A Phase 2 Multi-arm Open Label Study to Assess the Safety and Efficacy of EP0057 in Combination With Olaparib in Defined Populations of Patients With Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer
Status:
WITHDRAWN
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility analysis decision to terminate EP0057 compound and all Ellipses sponsored studies involving EP0057
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of EP0057 - 202 is to assess the safety and efficacy of EP0057 in combination with Olaparib a PARP inhibitor in two cancers where there is a high unmet need extensive stage small cell lung cancer SCLC and ATM-negative gastric cancer GC
EP0057-202 is a non-comparative multi-arm multi-centre open label Phase 2 study to determine the efficacy safety and tolerability of EP0057 in combination with olaparib an approved PARP inhibitor in defined patient populations with relapsed GC and SCLC
see Eligibility Criteria for definition of relapse for each tumour typepopulation The treatment cohorts will open sequentially at the Sponsors discretion and patients may be enrolled into each cohort concurrently
EP0057 is an investigational nanoparticle-drug conjugate administered intravenously The rationale for developing EP0057 is to enable selective entry of EP0057 into tumour tissue and as a result create preferential accumulation of EP0057 and therefore of the payload Camptothecin to translate into maximum tumour cell killing
EP0057-202 is a non-comparative multi-arm multi-centre open label Phase 2 study to determine the efficacy safety and tolerability of EP0057 in combination with olaparib an approved PARP inhibitor in defined patient populations with relapsed GC and SCLC
see Eligibility Criteria for definition of relapse for each tumour typepopulation The treatment cohorts will open sequentially at the Sponsors discretion and patients may be enrolled into each cohort concurrently
EP0057 is an investigational nanoparticle-drug conjugate administered intravenously The rationale for developing EP0057 is to enable selective entry of EP0057 into tumour tissue and as a result create preferential accumulation of EP0057 and therefore of the payload Camptothecin to translate into maximum tumour cell killing
Detailed Description:
EP0057 - 202 is a Phase 2 multi arm open label study in defined populations of patients with SCLC and GC
The Primary objectives of Arm 1 will be to investigate the efficacy as defined by best Objective Response Rate ORR of EP0057 in combination with Olaparib in patients with ataxia-telangiectasia mutated protein ATM-negative relapsed advanced GC
The Primary objectives of Arm 2 will be to investigate the efficacy as defined by the best ORR of EP0057 in combination with Olaparib in patients with relapsed extensive stage SCLC
The secondary objectives of both arms will be to further investigate the efficacy of EP0057 in combination with olaparib in the target patient population of each arm by assessment of the following
Progression-free survival PFS
Overall survival OS
Duration of overall response DoR
Disease control rate DCR
Secondary objectives of arms 1 and 2 also include exploring the safety and tolerability of EP0057 when combined with olaparib in patients with GC and SCLC
Exploratory objectives may or may not be performed during the course of the study but if so where available at the time of publication results from these analyses will be reported in the clinical study report CSR Exploratory objectives are to
Examine the PK characteristics of EP0057 in combination with olaparib
Investigate the impact of HRD homologous recombination deficiency status on primary and secondary endpoints as analysed by sub-groups of HRD status
It is estimated that approximately 115 patients will be enrolled into the study The study will aim to recruit 34 patients across both arms of the study in stage 1 The study will then aim to recruit an additional 81 patients across both arms in the second stage
The Primary objectives of Arm 1 will be to investigate the efficacy as defined by best Objective Response Rate ORR of EP0057 in combination with Olaparib in patients with ataxia-telangiectasia mutated protein ATM-negative relapsed advanced GC
The Primary objectives of Arm 2 will be to investigate the efficacy as defined by the best ORR of EP0057 in combination with Olaparib in patients with relapsed extensive stage SCLC
The secondary objectives of both arms will be to further investigate the efficacy of EP0057 in combination with olaparib in the target patient population of each arm by assessment of the following
Progression-free survival PFS
Overall survival OS
Duration of overall response DoR
Disease control rate DCR
Secondary objectives of arms 1 and 2 also include exploring the safety and tolerability of EP0057 when combined with olaparib in patients with GC and SCLC
Exploratory objectives may or may not be performed during the course of the study but if so where available at the time of publication results from these analyses will be reported in the clinical study report CSR Exploratory objectives are to
Examine the PK characteristics of EP0057 in combination with olaparib
Investigate the impact of HRD homologous recombination deficiency status on primary and secondary endpoints as analysed by sub-groups of HRD status
It is estimated that approximately 115 patients will be enrolled into the study The study will aim to recruit 34 patients across both arms of the study in stage 1 The study will then aim to recruit an additional 81 patients across both arms in the second stage
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?:
True
Is an FDA AA801 Violation?:
None