Carcinoma, Non-Small-Cell LungPhase 1/2NCT03799094
Vitamin C and Tyrosine Kinase Inhibitor in Lung Cancer Patients With Epidermal Growth Factor Receptor Mutations
A Phase 1/2 study testing Vitamin C and Tyrosine kinase inhibitor in people with Carcinoma, Non-Small-Cell Lung, run by Clifford Hospital, Guangzhou, China at 1 site in China.
Trial summary
This trial was to explore whether intravenous vitamin C can prolong resistance time of Tyrosine Kinase Inhibitor(TKI) on lung adenocarcinoma patients with Epidermal Growth Factor Receptor(EGFR) mutations, and can benefit NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Vitamin C and Tyrosine kinase inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2018to 31 Dec 2022
- 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
- Primary non-small cell lung cancer (adenocarcinoma) with EGFR mutations on exons 19 and 21.
- 18 years old to 75 years old.
- During the trial, patients were prescribed TKI drugs(received initial treatment within 2 months, or change medication within 2 months) and did not receive chemotherapy or radiotherapy at the same time.
- Eastern Cooperative Oncology Group (ECOG) performance status are 0 to 2.
- Expected survival over 3 months.
- Household registration is Guangdong Province.
Who cannot join
- Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), and uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.
- Glucose-6-phosphate dehydrogenase deficiency (G6PD) (a relative contraindication).
- Patients who are allergic to vitamin C.
- Patients with HIV and other infectious diseases.
- Patients who are taking anticoagulants and have coagulopathy;
- Combine dysfunction of important organs such as heart, lung, liver and kidney;
Show all 16Show fewer
- Patients with impaired renal function (serum creatinine content > 1.2 mg/dL)
- Compromised liver function with evidence of Serum total bilirubin content, Serum alanine aminotransferase(ALT) and aspartate transaminase(AST)> 2 times normal reference value.
- Pregnant or lactating female.
- Smoking and alcohol abuse patients;
- Anti-infective treatment is required for systemic or localized serious infections;
- Patients with hyperuricacidemia (normal: 91-456 μmol / 24h (8-40mg / 24h));
- Wilson's disease.
- Evidence of significant psychiatric disorder by history or examination that would prevent completion of the study or preclude informed consent.
- Any condition that impairs the patients' ability to swallow, which impairs drug absorption or drug kinetic parameters, including any kind of gastrointestinal resection or surgery;
- History of surgery of visceral organs within 6 weeks before the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Clifford Hospital
Guangzhou, 511495
Junwen Ou, PhD, 86-13556021810, oujunwen66@163.com
Junwen Ou, PhD
About this study
Official title: Clinical Outcomes of Intravenous Vitamin C Synergy With Tyrosine Kinase Inhibitor in Lung Adenocarcinoma Patients With Epidermal Growth Factor Receptor Mutations
This trial was to explore whether intravenous vitamin C can prolong resistance time of Tyrosine Kinase Inhibitor(TKI) on lung adenocarcinoma patients with Epidermal Growth Factor Receptor(EGFR) mutations, and can benefit NSCLC patients.
Read the detailed description
The effects of vitamin C in combination with tyrosine kinase inhibitor on tumor size, tumor markers, inflammatory factor levels, quality of life, duration of resistance, progression-free survival, and overall survival time were evaluated.
This trial is a low risk treatment, and has developed the appropriate safety measures and contingency plans to ensure patients' safety in the whole process.
Patients will be followed up after the end of the trial, and follow-up observations will be performed every month during the first year. Followed every 3 months in the second year for 3 years.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Vitamin C, Tyrosine kinase inhibitor
- Keywords
- tyrosine kinase inhibitor, Vitamin C, non-small cell lung cancer, progression-free survival, overall survival
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Also called Sodium Ascorbate
Participants will receive intravenous vitamin C therapy at the indicated dose.
Tyrosine kinase inhibitorDrug
Participants will receive Tyrosine kinase inhibitor therapy in cycles: continuous treatment at the indicated dose.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 75 patients received a weekly intravenous Vitamin C injection (dose: 30 g / time, once a week, treatment termination when the disease progress is confirmed) in combination with daily taking tyrosine kinase inhibitor. Receives: Drug: Vitamin C; Drug: Tyrosine kinase inhibitor |
| Control group | Experimental | 75 patients received tyrosine kinase inhibitor daily. (dose: Osimertinib 80 mg/d, or Tarceva 150 mg/d, or Iressa 0.25 g/d.) Receives: Drug: Tyrosine kinase inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
From the start of treatment until the patient has tumor progression or death
Measured: From the start date of treatment until the date of first documented progression or death, assessed up to 2 years
Secondary outcomes (1)
Overall survival
The length of time from the start of treatment for a disease until death
Measured: From the start date of treatment until the date of death from any cause, assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start5 Dec 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clifford Hospital, Guangzhou, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junwen Ou, PhD, Study chair, Clifford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799094
- Sponsor's protocol ID
- 2/2018-19
- Status last verified
- Jan 2019
- First submitted
- 2 Jan 2019
- Last updated
- 10 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Intravenous Vitamin C Synergy With Tyrosine Kinase Inhibitor in Lung Adenocarcinoma Patients With Epidermal Growth Factor Receptor Mutations
- ClinicalTrials.gov ID
- NCT03799094
- Acronym / sponsor ID
- 2/2018-19
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- tyrosine kinase inhibitor, Vitamin C, non-small cell lung cancer, progression-free survival, overall survival
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Clifford Hospital, Guangzhou, ChinaUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Jan 2019 (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.
This trial was to explore whether intravenous vitamin C can prolong resistance time of Tyrosine Kinase Inhibitor(TKI) on lung adenocarcinoma patients with Epidermal Growth Factor Receptor(EGFR) mutations, and can benefit NSCLC patients.
Detailed description
The effects of vitamin C in combination with tyrosine kinase inhibitor on tumor size, tumor markers, inflammatory factor levels, quality of life, duration of resistance, progression-free survival, and overall survival time were evaluated.
This trial is a low risk treatment, and has developed the appropriate safety measures and contingency plans to ensure patients' safety in the whole process.
Patients will be followed up after the end of the trial, and follow-up observations will be performed every month during the first year. Followed every 3 months in the second year for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Vitamin C, Drug: Tyrosine kinase inhibitor75 patients received a weekly intravenous Vitamin C injection (dose: 30 g / time, once a week, treatment termination when the disease progress is confirmed) in combination with daily taking tyrosine kinase inhibitor. |
| Control group | Experimental | Drug: Tyrosine kinase inhibitor75 patients received tyrosine kinase inhibitor daily. (dose: Osimertinib 80 mg/d, or Tarceva 150 mg/d, or Iressa 0.25 g/d.) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary non-small cell lung cancer (adenocarcinoma) with EGFR mutations on exons 19 and 21.
- 18 years old to 75 years old.
- During the trial, patients were prescribed TKI drugs(received initial treatment within 2 months, or change medication within 2 months) and did not receive chemotherapy or radiotherapy at the same time.
- Eastern Cooperative Oncology Group (ECOG) performance status are 0 to 2.
- Expected survival over 3 months.
Key exclusion criteria (16 listed)
- Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), and uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.
- Glucose-6-phosphate dehydrogenase deficiency (G6PD) (a relative contraindication).
- Patients who are allergic to vitamin C.
- Patients with HIV and other infectious diseases.
- Patients who are taking anticoagulants and have coagulopathy;
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 |
|---|---|---|
| Vitamin CAlso: Sodium AscorbateParticipants will receive intravenous vitamin C therapy at the indicated dose. | Drug | Experimental group |
| Tyrosine kinase inhibitorParticipants will receive Tyrosine kinase inhibitor therapy in cycles: continuous treatment at the indicated dose. | Drug | Control group, Experimental group |
Primary outcome
Progression free survival
Time frame: From the start date of treatment until the date of first documented progression or death, assessed up to 2 years
From the start of treatment until the patient has tumor progression or death
1 secondary outcome
Overall survival
Time frame: From the start date of treatment until the date of death from any cause, assessed up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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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.
Junwen Ou, PhD study chair
Clifford Hospital
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 Vitamin C and Tyrosine kinase inhibitor in people with Carcinoma, Non-Small-Cell Lung, run by Clifford Hospital, Guangzhou, China at 1 site in China.
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 6 inclusion and 16 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 Jan 2019. 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 China. 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 Junwen Ou, PhD (86-13556021810, oujunwen66@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: From the start date of treatment until the date of first documented progression or death, assessed up to 2 years). 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 Jan 2019.