Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00149396
Status:
COMPLETED
Last Update Posted:
2018-04-24
First Post:
2005-09-06
Brief Title:
Safety Efficacy of NV1020 in Colorectal Cancer Metastatic to the Liver
Sponsor:
MediGene
Organization:
MediGene
Study Overview
Official Title:
A Phase III Open-label Study to Evaluate the Safety and Anti-tumor Effects of NV1020 Administered Repeatedly Via Hepatic Artery Infusion Prior to Second-line Chemotherapy in Patients With Colorectal Adenocarcinoma Metastatic to the Liver
Status:
COMPLETED
Status Verified Date:
2018-03
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:
This study is an open-label study It has two stages Stage 1 is a dose escalation phase of the study to determine and evaluate the safety and tolerability of repeated treatments with a genetically engineered herpes simplex virus NV1020 administered locoregionally to the liver
Stage 2 is to evaluate the dose found in Stage 1 to be optimally tolerated Stage 2 is to assess the efficacy of the optimally tolerated dose of NV1020 by itself and in combination with second-line chemotherapy
Assignment to Stage 1 or Stage 2 of the study is determined by when the patient enters the study
Stage 2 is to evaluate the dose found in Stage 1 to be optimally tolerated Stage 2 is to assess the efficacy of the optimally tolerated dose of NV1020 by itself and in combination with second-line chemotherapy
Assignment to Stage 1 or Stage 2 of the study is determined by when the patient enters the study
Detailed Description:
This study is designed to evaluate the effects of repeated treatments with NV1020 prior to second-line chemotherapy and to determine an appropriate dose level of NV1020 in a multiple dose regimen for later Phase II studies
Sequential open-label cohort dose escalation of NV1020 stage 1 followed by an expansion of one selected dose cohort stage 2
Study results will be reviewed periodically by an independent DSMB who will approve each cohort dose escalation
During the dose escalation stage 3 cohorts of patients 3 in each will be treated with 4 fixed doses of NV1020 with the dose level increasing for successive cohorts A patient will be observed for a minimum of 7 days after the first NV1020 infusion before the next patient in the same cohort is given NV1020 The first patient in the next higher dose cohort will receive NV1020 no earlier than 14 days after the last patient in the prior cohort has finished NV1020 infusions One additional cohort half log higher increment may be approved by the DSMB if considered necessary to define MTD Dose-limiting toxicity will be determined using NCI CTC criteria and a suitable dose level for later evaluation will be selected
In the second stage of the study the dose cohort considered to show the best therapeutic index will be expanded by the addition of 18 further patients For all patients in this study investigational treatment with NV1020 will be followed by a minimum of two cycles of second-line therapy using anti-neoplastic drugs approved by the FDA for colorectal cancer and selected by the investigator
All patients will be followed up periodically until death Permission for autopsy will be sought
Sequential open-label cohort dose escalation of NV1020 stage 1 followed by an expansion of one selected dose cohort stage 2
Study results will be reviewed periodically by an independent DSMB who will approve each cohort dose escalation
During the dose escalation stage 3 cohorts of patients 3 in each will be treated with 4 fixed doses of NV1020 with the dose level increasing for successive cohorts A patient will be observed for a minimum of 7 days after the first NV1020 infusion before the next patient in the same cohort is given NV1020 The first patient in the next higher dose cohort will receive NV1020 no earlier than 14 days after the last patient in the prior cohort has finished NV1020 infusions One additional cohort half log higher increment may be approved by the DSMB if considered necessary to define MTD Dose-limiting toxicity will be determined using NCI CTC criteria and a suitable dose level for later evaluation will be selected
In the second stage of the study the dose cohort considered to show the best therapeutic index will be expanded by the addition of 18 further patients For all patients in this study investigational treatment with NV1020 will be followed by a minimum of two cycles of second-line therapy using anti-neoplastic drugs approved by the FDA for colorectal cancer and selected by the investigator
All patients will be followed up periodically until death Permission for autopsy will be sought
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