Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05721872
Status:
RECRUITING
Last Update Posted:
2023-02-10
First Post:
2023-01-18
Brief Title:
Efficacy Tolerability and Safety of Intravenous D-VC With ATO in Patients With AdvancedMetastatic Colorectal Cancer
Sponsor:
Nazarbayev University
Organization:
Nazarbayev University
Study Overview
Official Title:
An Exploratory Phase III Single-center Clinical Trial of the Efficacy Tolerability and Safety of Intravenous D-isoascorbic Acid With Arsenic Trioxide in Patients With AdvancedMetastatic Colorectal Cancer Who Have Exhausted Standard Therapy
Status:
RECRUITING
Status Verified Date:
2023-02
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:
None
Brief Summary:
The goal of this exploratory phase III single-center clinical trial is to evaluate effectiveness tolerability and safety of Intravenous D-isoascorbic Acid D-VC With Arsenic Trioxide in Patients With AdvancedMetastatic Colorectal Cancer Who Have Exhausted Standard Therapy The main questions are to learn about effectiveness tolerability and safety of Intravenous D-isoascorbic Acid D-VC With Arsenic Trioxide
The study aims to
1 Assess the tolerability and pharmacokinetics of D-isoascorbic acid D-VC with a single intravenous injection in the monotherapy regimen and in the sequential administration regimen with arsenic trioxide ATO in patients on standard therapy for advancedmetastatic malignancies Phase I
2 Evaluate the efficacy and safety of D-isoascorbic acid D-VC with repeated intravenous administration in the mode of sequential administration with arsenic trioxide ATO in patients who have exhausted standard therapy for advancedmetastatic colorectal cancer Phase II
In phase I participants will receive single intravenous administration as monotherapy of D-isoascorbic acid D-VC with dose escalation 005 01 02 gkgday and with arsenic trioxide ATO
Patients who have satisfactorily tolerated the study drug in combination with arsenic trioxide ATO in a phase I study are transferred to a phase II clinical trial
To study the safety and efficacy of the study drug in phase II D-VC after the administration of ATO will be implemented in 2 groups
Study group 1 ATO at a dose of 015 mg kg day after intravenous administration after 2 hours D-VC intravenously once a day at the maximum tolerated dose determined at the end of phase I for at least 15 patients
Group 2 standard therapy 15 patients
For the phase I researchers will compare laboratory tests including clinical biochemistry and hematology vital signs clinical adverse events diseases symptoms and complaints and other specific safety tests for example an electrocardiogram ophthalmic examination between groups They will also measure the degree to which overt adverse reactions can be subjectively tolerated by the subject of the study
For the phase II researchers will compare degrees of tumor volume reduction on CT objective response rate ORR based on BICR according to RECIST v11 between test and standard therapy groups They will also continue evaluation of safety and tolerability of ATO D-VC combination therapy
The study aims to
1 Assess the tolerability and pharmacokinetics of D-isoascorbic acid D-VC with a single intravenous injection in the monotherapy regimen and in the sequential administration regimen with arsenic trioxide ATO in patients on standard therapy for advancedmetastatic malignancies Phase I
2 Evaluate the efficacy and safety of D-isoascorbic acid D-VC with repeated intravenous administration in the mode of sequential administration with arsenic trioxide ATO in patients who have exhausted standard therapy for advancedmetastatic colorectal cancer Phase II
In phase I participants will receive single intravenous administration as monotherapy of D-isoascorbic acid D-VC with dose escalation 005 01 02 gkgday and with arsenic trioxide ATO
Patients who have satisfactorily tolerated the study drug in combination with arsenic trioxide ATO in a phase I study are transferred to a phase II clinical trial
To study the safety and efficacy of the study drug in phase II D-VC after the administration of ATO will be implemented in 2 groups
Study group 1 ATO at a dose of 015 mg kg day after intravenous administration after 2 hours D-VC intravenously once a day at the maximum tolerated dose determined at the end of phase I for at least 15 patients
Group 2 standard therapy 15 patients
For the phase I researchers will compare laboratory tests including clinical biochemistry and hematology vital signs clinical adverse events diseases symptoms and complaints and other specific safety tests for example an electrocardiogram ophthalmic examination between groups They will also measure the degree to which overt adverse reactions can be subjectively tolerated by the subject of the study
For the phase II researchers will compare degrees of tumor volume reduction on CT objective response rate ORR based on BICR according to RECIST v11 between test and standard therapy groups They will also continue evaluation of safety and tolerability of ATO D-VC combination therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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