Colorectal CancerPhase 1/2NCT05721872
Efficacy, Tolerability and Safety of Intravenous D-VC With ATO in Patients With Advanced/Metastatic Colorectal Cancer
A Phase 1/2 study testing D-isoascorbic Acid (D-VC) With Arsenic Trioxide (ATO) and FOLFOX/FOLFIRI regimen in people with Colorectal Cancer and Metastatic Colorectal Cancer, run by Nazarbayev University at 1 site in Kazakhstan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Metastatic Colorectal Cancer
- What is being tested?
- D-isoascorbic Acid (D-VC) With Arsenic Trioxide (ATO) and FOLFOX/FOLFIRI regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteKazakhstan
- Study dates
- 15 Feb 2023to Nov 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent to participate in the study
- patients of the second clinical group with malignant neoplasms of a common/metastatic form that have exhausted standard therapy.
- patients who have received at least 3 lines of standard therapy, including those with the use of targeted drugs, patients who have exhausted the possibilities of using specialized drugs, as part of the recommendations of treatment protocols
- the presence of "+" KRAS / NRAS status of the primary tumor or metastatic focus (determined in LEKzone 2, codons 12, 13, 61)
- ≥1 measurable lesion defined by RECIST v1.1
- ECOG PS 0.1 or 2
Show all 12Show fewer
- for both groups (30 patients, considering 20% decrease from the study):
- informed consent to participate in the study
- patients of the second clinical group with advanced/metastatic colorectal cancer
- Patients must have previously received at least 3 lines of standard drug therapy, including those with the use of targeted drugs, who have exhausted the possibilities of using specialized drugs, as part of the recommendations of colorectal cancer treatment protocols - the presence of "+" KRAS / NRAS status of the primary tumor, or metastatic focus (determined in exon 2, codons 12, 13, 61)
- ≥1 measurable lesion defined by RECIST v1.1
- ECOG PS 0.1 or 2
Who cannot join
- age up to 18 years
- pregnancy and lactation
- patients with an autoimmune disease or with a medical diagnosis requiring systemic immunosuppression
- decompensated diabetes mellitus
- renal failure, urolithiasis
- diabetes
Show all 43Show fewer
- thrombophlebitis, tendency to thrombosis
- severe lung disease, dyspnea at rest, pleural effusion
- cardiovascular insufficiency, ejection fraction of the heart <40%
- sensory neuropathy of the 1st degree of any etiology
- uncontrolled infections
- persons from the category of "vulnerable patients" (homeless, military personnel, incapacitated, patients in emergency conditions, other persons who may be subjected to pressure);
- Allergy in history and during screening (drug, pollen, etc.);
- participation in any other clinical trial;
- hypersensitivity to arsenic;
- individual intolerance to ascorbic acid;
- thrombophlebitis and thrombosis, a tendency to thrombosis in history;
- increased blood clotting and pathologies associated with this deviation;
- diabetes;
- nephrolithiasis or nephrolithiasis;
- the patient does not agree to perform the procedures required by the protocol and is unable to adhere to the schedule of procedures.
- if the patients have any other laboratory or other abnormalities, in the opinion of the Investigator, that can harm the patients and the results of the study.
- Phase II:
- age up to 18 years
- patients with an autoimmune disease or with a medical diagnosis requiring systemic immunosuppression
- decompensated diabetes mellitus
- renal failure, urolithiasis
- thrombophlebitis, tendency to thrombosis
- severe lung disease, dyspnea at rest, pleural effusion
- cardiovascular insufficiency, ejection fraction of the heart <40%
- sensory neuropathy of the 1st degree of any etiology
- uncontrolled infections
- persons from the category of "vulnerable patients" (homeless, military personnel, incapacitated, patients in emergency conditions, other persons who may be subjected to pressure);
- Allergy in history and during screening (drug, pollen, etc.);
- participation in any other clinical trial;
- hypersensitivity to arsenic;
- individual intolerance to ascorbic acid;
- thrombophlebitis and thrombosis, a tendency to thrombosis in history;
- increased blood clotting and pathologies associated with this deviation;
- diabetes;
- nephrolithiasis or nephrolithiasis;
- the patient does not agree to perform the procedures required by the protocol and is unable to adhere to the schedule of procedures.
- if the patients have any other laboratory or other abnormalities, in the opinion of the Investigator, that can harm the patients and the results of the study.
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site, 1 recruiting
- Recruiting
Kazakh Institute of Oncology and Radiology
Almaty, 050000
Kaldygul Smagulova, MD, PhD, +7-727-292-77-55, kazior@onco.kz
About this study
Official title: An Exploratory Phase I/II Single-center Clinical Trial of the Efficacy, Tolerability and Safety of Intravenous D-isoascorbic Acid With Arsenic Trioxide in Patients With Advanced/Metastatic Colorectal Cancer Who Have Exhausted Standard Therapy
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:
Read more
- 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)
- 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.
- Conditions
- Colorectal Cancer, Metastatic Colorectal Cancer
- Being tested
- D-isoascorbic Acid (D-VC) With Arsenic Trioxide (ATO), FOLFOX/FOLFIRI regimen
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-isoascorbic Acid (D-VC) With Arsenic Trioxide (ATO)Combination product
After 2 hours of intravenous administration of arsenic trioxide (ATO) (at a dose of 0.15 mg / kg / day) participants will further receive D-isoascorbic acid (D-VC) intravenously once a day at the maximum tolerated dose, determined at the end of phase I.
Phase 1 - Scheme 1 - single intravenous administration in monotherapy with dose escalation (0.05, 0.1, 0.15 g/kg/day); Scheme 2 - single intravenous administration in the mode of sequential administration with arsenic trioxide with dose escalation of D-isoascorbic acid (0.05, 0.1, 0.15 g/kg/day).
Phase 2 - Study group 1: After 2 hours of intravenous administration of arsenic trioxide (ATO) (at a dose of 0.15 mg / kg / day) participants will further receive D-isoascorbic acid (D-VC) intravenously once a day at the maximum tolerated dose, determined at the end of phase I for at least 15 patients.
FOLFOX/FOLFIRI regimenDrug
FOLFOX - oxaliplatin 85mg/m2 1 day Leucovorin 200mg/m2 IV 2h, 1, 2 days 5 - Fluorouracil 400mg/m2 IV bolus, 1, 2 days 5 - Fluorouracil 600mg/m2 IV 22h, 1, 2 days
FOLFIRI Irinotecan 180 mg/m2 IV Leucovorin 400 mg/m2 IV Fluorouracil bolus 400 mg/m2 IV Fluorouracil infusional 2400 mg/m2 IV Courses are held every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Combination of D-isoascorbic acid (D-VC) with arsenic trioxide (ATO)-Phase 1 | Experimental | 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. Receives: Combination Product: D-isoascorbic Acid (D-VC) With Arsenic Trioxide (ATO) |
| Combination of D-isoascorbic acid (D-VC) with arsenic trioxide (ATO)-Phase 2 | Experimental | After 2 hours of intravenous administration of arsenic trioxide (ATO) (at a dose of 0.15 mg / kg / day) participants will further receive D-isoascorbic acid (D-VC) intravenously once a day at the maximum tolerated dose, determined at the end of phase I. Receives: Combination Product: D-isoascorbic Acid (D-VC) With Arsenic Trioxide (ATO) |
| Standard therapy (FOLFOX/FOLFIRI)-Phase 2 | Active comparator | Drug: FOLFOX/FOLFIRI regimen FOLFOX - oxaliplatin 85mg/m2 1 day, Leucovorin 200mg/m2 IV 2h, 1, 2 days, 5 - Fluorouracil 400mg/m2 IV bolus, 1, 2 days, 5 - Fluorouracil 600mg/m2 IV 22h, 1, 2 days
FOLFIRI - Irinotecan 180 mg/m2 IV, Leucovorin 400 mg/m2 IV, Fluorouracil bolus 400 mg/m2 IV, Fluorouracil infusional 2400 mg/m2 IV. Courses are held every 2 weeks Receives: Drug: FOLFOX/FOLFIRI regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline DV-C levels at 1 hour
Patients who have satisfactorily tolerated D-isoascorbic Acid (D-VC) in combination with arsenic trioxide (ATO) in a phase I study are transferred to a phase II clinical trial.
Measured: Baseline, 1 hour
Change from baseline DV-C levels at 3 hours
Patients who have satisfactorily tolerated D-isoascorbic Acid (D-VC) in combination with arsenic trioxide (ATO) in a phase I study are transferred to a phase II clinical trial.
Measured: Baseline, 3 hours
Change from baseline DV-C levels at 6 hours
Patients who have satisfactorily tolerated D-isoascorbic Acid (D-VC) in combination with arsenic trioxide (ATO) in a phase I study are transferred to a phase II clinical trial.
Measured: Baseline, 6 hours
Change from baseline DV-C levels at 24 hours
Patients who have satisfactorily tolerated D-isoascorbic Acid (D-VC) in combination with arsenic trioxide (ATO) in a phase I study are transferred to a phase II clinical trial.
Measured: Baseline, 24 hours
Response to D-isoascorbic Acid (D-VC) in combination with arsenic trioxide (ATO)
Objective partial or complete response by RECIST 1.1, confirmed on a second CT scan at least 4 weeks apart
Measured: Baseline, 4 weeks
Secondary outcomes (4)
Change from baseline number of participants with treatment-related adverse events as assessed by CTCAE v4.0 at 1 hour
Adverse events in patients will be assessed by CTCAE v4.0
Measured: Baseline, 1 hour
Change from baseline number of participants with treatment-related adverse events as assessed by CTCAE v4.0 at 3 hours
Adverse events in patients will be assessed by CTCAE v4.0
Measured: Baseline, 3 hours
Change from baseline number of participants with treatment-related adverse events as assessed by CTCAE v4.0 at 6 hours
Adverse events in patients will be assessed by CTCAE v4.0
Measured: Baseline, 6 hours
Change from baseline number of participants with treatment-related adverse events as assessed by CTCAE v4.0 at 24 hours
Adverse events in patients will be assessed by CTCAE v4.0
Measured: Baseline, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nazarbayev University
- Sponsor type
- University, hospital or other
- Collaborators
- National Laboratory Astana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721872
- Sponsor's protocol ID
- BR11765589
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Phase I/II Single-center Clinical Trial of the Efficacy, Tolerability and Safety of Intravenous D-isoascorbic Acid With Arsenic Trioxide in Patients With Advanced/Metastatic Colorectal Cancer Who Have Exhausted Standard Therapy
- ClinicalTrials.gov ID
- NCT05721872
- Acronym / sponsor ID
- BR11765589
- Conditions
- Colorectal Cancer, Metastatic Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Nazarbayev UniversityUniversity, hospital or other
- Collaborators
- National Laboratory Astana
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination of D-isoascorbic acid (D-VC) with arsenic trioxide (ATO)-Phase 1 | Experimental | Combination Product: D-isoascorbic Acid (D-VC) With Arsenic Trioxide (ATO)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. |
| Combination of D-isoascorbic acid (D-VC) with arsenic trioxide (ATO)-Phase 2 | Experimental | Combination Product: D-isoascorbic Acid (D-VC) With Arsenic Trioxide (ATO)After 2 hours of intravenous administration of arsenic trioxide (ATO) (at a dose of 0.15 mg / kg / day) participants will further receive D-isoascorbic acid (D-VC) intravenously once a day at the maximum tolerated dose, determined at the end of phase I. |
| Standard therapy (FOLFOX/FOLFIRI)-Phase 2 | Active comparator | Drug: FOLFOX/FOLFIRI regimenDrug: FOLFOX/FOLFIRI regimen FOLFOX - oxaliplatin 85mg/m2 1 day, Leucovorin 200mg/m2 IV 2h, 1, 2 days, 5 - Fluorouracil 400mg/m2 IV bolus, 1, 2 days, 5 - Fluorouracil 600mg/m2 IV 22h, 1, 2 days FOLFIRI - Irinotecan 180 mg/m2 IV, Leucovorin 400 mg/m2 IV, Fluorouracil bolus 400 mg/m2 IV, Fluorouracil infusional 2400 mg/m2 IV. Courses are held every 2 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- informed consent to participate in the study
- patients of the second clinical group with malignant neoplasms of a common/metastatic form that have exhausted standard therapy.
- patients who have received at least 3 lines of standard therapy, including those with the use of targeted drugs, patients who have exhausted the possibilities of using specialized drugs, as part of the recommendations of treatment protocols
- the presence of "+" KRAS / NRAS status of the primary tumor or metastatic focus (determined in LEKzone 2, codons 12, 13, 61)
- ≥1 measurable lesion defined by RECIST v1.1
Key exclusion criteria (43 listed)
- age up to 18 years
- pregnancy and lactation
- patients with an autoimmune disease or with a medical diagnosis requiring systemic immunosuppression
- decompensated diabetes mellitus
- renal failure, urolithiasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-isoascorbic Acid (D-VC) With Arsenic Trioxide (ATO)After 2 hours of intravenous administration of arsenic trioxide (ATO) (at a dose of 0.15 mg / kg / day) participants will further receive D-isoascorbic acid (D-VC) intravenously once a day at the maximum tolerated dose, determined at the end of phase I. Phase 1 - Scheme 1 - single intravenous administration in monotherapy with dose escalation (0.05, 0.1, 0.15 g/kg/day); Scheme 2 - single intravenous administration in the mode of sequential administration with arsenic trioxide with dose escalation of D-isoascorbic acid (0.05, 0.1, 0.15 g/kg/day). Phase 2 - Study group 1: After 2 hours of intravenous administration of arsenic trioxide (ATO) (at a dose of 0.15 mg / kg / day) participants will further receive D-isoascorbic acid (D-VC) intravenously once a day at the maximum tolerated dose, determined at the end of phase I for at least 15 patients. | Combination product | Combination of D-isoascorbic acid (D-VC) with arsenic trioxide (ATO)-Phase 1, Combination of D-isoascorbic acid (D-VC) with arsenic trioxide (ATO)-Phase 2 |
| FOLFOX/FOLFIRI regimenFOLFOX - oxaliplatin 85mg/m2 1 day Leucovorin 200mg/m2 IV 2h, 1, 2 days 5 - Fluorouracil 400mg/m2 IV bolus, 1, 2 days 5 - Fluorouracil 600mg/m2 IV 22h, 1, 2 days FOLFIRI Irinotecan 180 mg/m2 IV Leucovorin 400 mg/m2 IV Fluorouracil bolus 400 mg/m2 IV Fluorouracil infusional 2400 mg/m2 IV Courses are held every 2 weeks | Drug | Standard therapy (FOLFOX/FOLFIRI)-Phase 2 |
Primary outcome
Change from baseline DV-C levels at 1 hour
Time frame: Baseline, 1 hour
Patients who have satisfactorily tolerated D-isoascorbic Acid (D-VC) in combination with arsenic trioxide (ATO) in a phase I study are transferred to a phase II clinical trial.
Change from baseline DV-C levels at 3 hours
Time frame: Baseline, 3 hours
Patients who have satisfactorily tolerated D-isoascorbic Acid (D-VC) in combination with arsenic trioxide (ATO) in a phase I study are transferred to a phase II clinical trial.
Change from baseline DV-C levels at 6 hours
Time frame: Baseline, 6 hours
Patients who have satisfactorily tolerated D-isoascorbic Acid (D-VC) in combination with arsenic trioxide (ATO) in a phase I study are transferred to a phase II clinical trial.
Change from baseline DV-C levels at 24 hours
Time frame: Baseline, 24 hours
Patients who have satisfactorily tolerated D-isoascorbic Acid (D-VC) in combination with arsenic trioxide (ATO) in a phase I study are transferred to a phase II clinical trial.
Response to D-isoascorbic Acid (D-VC) in combination with arsenic trioxide (ATO)
Time frame: Baseline, 4 weeks
Objective partial or complete response by RECIST 1.1, confirmed on a second CT scan at least 4 weeks apart
4 secondary outcomes
Change from baseline number of participants with treatment-related adverse events as assessed by CTCAE v4.0 at 1 hour
Time frame: Baseline, 1 hour
Change from baseline number of participants with treatment-related adverse events as assessed by CTCAE v4.0 at 3 hours
Time frame: Baseline, 3 hours
Change from baseline number of participants with treatment-related adverse events as assessed by CTCAE v4.0 at 6 hours
Time frame: Baseline, 6 hours
Change from baseline number of participants with treatment-related adverse events as assessed by CTCAE v4.0 at 24 hours
Time frame: Baseline, 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing D-isoascorbic Acid (D-VC) With Arsenic Trioxide (ATO) and FOLFOX/FOLFIRI regimen in people with Colorectal Cancer and Metastatic Colorectal Cancer, run by Nazarbayev University at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dos Sarbassov, PhD (+77172705873, nlagen.dir@nu.edu.kz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline DV-C levels at 1 hour (time frame: Baseline, 1 hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.