Efficacy, Tolerability and Safety of Intravenous D-VC With ATO in Patients With Advanced/Metastatic Colorectal Cancer
Status:
Recruiting
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
Summary
The goal of this exploratory phase I/II single-center clinical trial is to evaluate
effectiveness, tolerability, and safety of Intravenous D-isoascorbic Acid (D-VC) With Arsenic
Trioxide in Patients With Advanced/Metastatic 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
advanced/metastatic 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 advanced/metastatic colorectal cancer
(Phase II)
In phase I participants will receive single intravenous administration as monotherapy of
D-isoascorbic acid (D-VC) with dose escalation (0.05, 0.1, 0.2 g/kg/day) 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 0.15 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 v1.1 between test and standard therapy
groups. They will also continue evaluation of safety and tolerability of ATO + D-VC
combination therapy.