Ignite Creation Date:
2024-05-06 @ 1:02 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01711398
Status:
COMPLETED
Last Update Posted:
2015-02-12
First Post:
2012-10-09
Brief Title:
Dose-finding Adaptive Phase IIIa Study to Assess Safety Tolerability Pharmacokinetics and Preliminary Efficacy of IPP-204106N on Advanced Solid Tumors
Sponsor:
Elro Pharma
Organization:
Elro Pharma
Study Overview
Official Title:
A Non-randomized Open-label Multi-centric Dose-finding Adaptive Phase IIIa Study to Assess Safety Tolerability Pharmacokinetics and Preliminary Efficacy of Repeated Intravenous IPP-204106N Administrations in Adult Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2015-02
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:
IP N02
Brief Summary:
The experimental plan will consist in
The dose-finding Bayesian adaptive phase I portion of the study is designed to determine the optimal and recommended dose of IPP-204106N using a Bayesian with memory design with combined toxicity and pharmacokinetic endpoints to determine doses for successive cohorts of three patients The Bayesian methodology allows updating information as the trial progresses and stopping the trial as soon as the information obtained is deemed to be sufficient Preclinical toxicokinetic studies of N6L and IPP-204106N in dogs and the first phase I clinical trial with N6L will be used to inform the prior distribution in the present study
The decisional part according to the results of the phase I portion of the study will define the optimal dose recommended for the phase IIa portion of the study
The phase IIa portion of the study will confirm the optimal dose and is designed to evaluate the safety and the preliminary efficacy of IPP-204106N in an expanded patient population treated at the recommended dose of IPP-204106N
The dose-finding Bayesian adaptive phase I portion of the study is designed to determine the optimal and recommended dose of IPP-204106N using a Bayesian with memory design with combined toxicity and pharmacokinetic endpoints to determine doses for successive cohorts of three patients The Bayesian methodology allows updating information as the trial progresses and stopping the trial as soon as the information obtained is deemed to be sufficient Preclinical toxicokinetic studies of N6L and IPP-204106N in dogs and the first phase I clinical trial with N6L will be used to inform the prior distribution in the present study
The decisional part according to the results of the phase I portion of the study will define the optimal dose recommended for the phase IIa portion of the study
The phase IIa portion of the study will confirm the optimal dose and is designed to evaluate the safety and the preliminary efficacy of IPP-204106N in an expanded patient population treated at the recommended dose of IPP-204106N
Detailed Description:
None
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