NSCLCPhase 1NCT04390984
Drug-drug Interaction Study of Gefitinb on Apatinib in NSCLC Patients
A Phase 1 study testing Apatinib Mesylate, Gefitinib in people with NSCLC, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The primary objective of the study was to assess the effect of gefitinib on the pharmacokinetics of apatinib mesylate in lung cancer patients. The secondary objective of the study was to assess the pharmacokinetics of gefitinib, and to assess the safety of apatinib mesylate and gefitinib administered in lung cancer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Apatinib Mesylate, Gefitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2020to Mar 2021
- Phase
- Phase 1
- 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
- 18-75 years of age.
- ECOG performance status: level 0~1;
- Anticipated life expectancy ≥ 12 weeks;
- Lung cancer patients;
- Major organs in good function;
- Agree to take approved method of contraception during the clinical trail and 8 weeks after the last dose of apatinib. Female subject should be negative in the pregnancy test;
- Able to comprehend and willing to sign an informed consent form (ICF)
Who cannot join
- History of drug allergy, or allergic to apatinib or gefitinib or ingredients;
- Squamous cancer, small-cell lung cancer;
- Symptomatic central nervous system (CNS) metastases
- Hypertension and couldn't be controlled with medicine;
- Coagulation disorders;
- Clinical significant bleeding in 3 months prior dosing;
Show all 18Show fewer
- Had surgery in four weeks prior dosing;
- Disease that affect drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction;
- Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess in 6 months prior dosing;
- Urine protein ≥++, and urine protein ≥1.0g in 24 hours;
- Active infection and need antimicrobial treatments;
- History of psychiatric substance abuse;
- Take any clinical trial drugs within four weeks prior dosing;
- Take any drugs that have effect on gastric acid and metabolic enzyme CYP 3A and CYP2D6;
- Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection;
- Addicted to alcohol and tobacco;
- Take grapefruit or grapefruit product, drinks containing caffeine, xanthine and alcohol in 48 hours prior dosing;
- The investigator believes that the subjects are not eligible to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Univercity Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang, 86-020-87343458, Zhangli6@mail.sysu.edu.cn
About this study
Official title: A Multi-center, Open-label, Fixed-sequence Study of Effect of Gefitinib on the Pharmacokinetics of Apatinib Mesylate in Non-squamous, Non-small-cell Lung Cancer Patients
The primary objective of the study was to assess the effect of gefitinib on the pharmacokinetics of apatinib mesylate in lung cancer patients.
The secondary objective of the study was to assess the pharmacokinetics of gefitinib, and to assess the safety of apatinib mesylate and gefitinib administered in lung cancer patients.
- Conditions
- NSCLC
- Being tested
- Apatinib Mesylate, Gefitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib Mesylate, GefitinibDrug
Subjects will be administrated with 500mg apatinib on day 1 and day 12-15, and administrated with gefitinib on day 4-15.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects will be administrated with 500mg apatinib on day 1 and day 12-15, and administrated with gefitinib on day 4-15. Receives: Drug: Apatinib Mesylate, Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum Observed Plasma Concentration for apatinib
Measured: 0-24 hours
AUC0-τ
Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 hours
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start26 May 2020
- Primary completionFeb 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All the subjects will administrated with apatinib and gefitinib following the same sequence to assess the effect of gefitinib on the pharmacokinetics of apatinib in NSCLC patients
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390984
- Sponsor's protocol ID
- HR-APTN-DDI-004
- Status last verified
- Jan 2021
- First submitted
- 13 May 2020
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ma Y, Chen Q, Zhang Y, Xue J, Liu Q, Zhao Y, Yang Y, Huang Y, Fang W, Hou Z, Li S, Wang J, Zhang L, Zhao H. Pharmacokinetics, safety, tolerability, and feasibility of apatinib in combination with gefitinib in stage IIIB-IV EGFR-mutated non-squamous NSCLC: a drug-drug interaction study. Cancer Chemother Pharmacol. 2023 Nov;92(5):411-418. doi: 10.1007/s00280-023-04563-2. Epub 2023 Jul 31.
PubMed 37518060
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Fixed-sequence Study of Effect of Gefitinib on the Pharmacokinetics of Apatinib Mesylate in Non-squamous, Non-small-cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT04390984
- Acronym / sponsor ID
- HR-APTN-DDI-004
- Conditions
- NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 May 2020 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 18 May 2020 (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 primary objective of the study was to assess the effect of gefitinib on the pharmacokinetics of apatinib mesylate in lung cancer patients.
The secondary objective of the study was to assess the pharmacokinetics of gefitinib, and to assess the safety of apatinib mesylate and gefitinib administered in lung cancer patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All the subjects will administrated with apatinib and gefitinib following the same sequence to assess the effect of gefitinib on the pharmacokinetics of apatinib in NSCLC patients
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Apatinib Mesylate, GefitinibSubjects will be administrated with 500mg apatinib on day 1 and day 12-15, and administrated with gefitinib on day 4-15. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-75 years of age.
- ECOG performance status: level 0~1;
- Anticipated life expectancy ≥ 12 weeks;
- Lung cancer patients;
- Major organs in good function;
Key exclusion criteria (18 listed)
- History of drug allergy, or allergic to apatinib or gefitinib or ingredients;
- Squamous cancer, small-cell lung cancer;
- Symptomatic central nervous system (CNS) metastases
- Hypertension and couldn't be controlled with medicine;
- Coagulation disorders;
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 |
|---|---|---|
| Apatinib Mesylate, GefitinibSubjects will be administrated with 500mg apatinib on day 1 and day 12-15, and administrated with gefitinib on day 4-15. | Drug | 1 |
Primary outcome
Cmax
Time frame: 0-24 hours
Maximum Observed Plasma Concentration for apatinib
AUC0-τ
Time frame: 0-24 hours
Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Derived from this study: PubMed 37518060Ma Y, Chen Q, Zhang Y, Xue J, Liu Q, Zhao Y, Yang Y, Huang Y, Fang W, Hou Z, Li S, Wang J, Zhang L, Zhao H. Pharmacokinetics, safety, tolerability, and feasibility of apatinib in combination with gefitinib in stage IIIB-IV EGFR-mutated non-squamous NSCLC: a drug-drug interaction study. Cancer Chemother Pharmacol. 2023 Nov;92(5):411-418. doi: 10.1007/s00280-023-04563-2. Epub 2023 Jul 31.
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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.
Li Zhang principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apatinib Mesylate, Gefitinib in people with NSCLC, run by Jiangsu HengRui Medicine Co., Ltd. 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 7 inclusion and 18 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 11 Jan 2021. 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 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.
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 Yuya Wang, Ph.D (13918749176, wangyuya@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 0-24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04390984, which also lists 1 linked publication.
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 11 Jan 2021.