NSCLC Stage IVNCT03594682
Optimizing the Therapeutic Dose of Apatinib Mesylate Tablets in Patients With Lung Cancer by Dose Titration：A Real World Exploratory Study
A study testing Intervention/treatment in people with NSCLC Stage IV and NSCLC Stage IIIB, run by Beijing Chest Hospital.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of two different administration methods of apatinib in NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- NSCLC Stage IV, NSCLC Stage IIIB
- What is being tested?
- Intervention/treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Jul 2020
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18；
- Locally advanced/metastatic non-small lung cancer (IIIb / IV) confirmed by pathology with measurable lesions ；
- Patients with wild type EGFR/ALK must received two kinds of systemic chemotherapy before；Patients with EGFR mutation positive had experienced treatment failure with TKI in first line and Chemotherapy in second line ；
- ECOG：0-4；
- The subjects were treated with other drugs has been restored (NCI CTCAE version 4.0 class 1 or less), which accept nitroso urea or mitomycin interval 6 weeks or more; Accept other cytotoxic drugs, bevacizumab (Avastin) (except local palliative radiotherapy), radiotherapy or surgery four weeks or more. EGFR TKI ≥2 weeks; Main organs function is normal；
- Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib；
- Patients voluntarily entered the study and signed informed consent form (ICF).
Who cannot join
- brain MRI, CT or venography confirmed that there are brain hemorrhage symptoms；
- Tumor invade big vessels or close to big vessels (less than 5mm)；
- Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy).；
- Patients with with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms)；
- Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy
- Urine protein≥++, or urine protein in 24 hours≥1.0g
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- CTCAE 2 degrees or more peripheral neuropathy, except the trauma;
- Unhealed bone fracture or wound for long time；
- Patients who received systemic antibiotic treatment of serious infections;
- Decompensated diabetes or high dose of glucocorticoid treatment other banned disease;
- Patients with active hepatitis B virus or hepatitis c virus infection；
- Patients with obvious factors affecting absorption of oral drugs, such as difficulties in swallowing, chronic diarrhea and intestinal obstruction, etc.
- Received big surgery, had bone fracture or ulcer in 4 weeks.
- Within 6 weeks before random severe weight loss (> 10%);
- Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc；
- Random 12 months before the artery/vein thrombosis events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.；
- Known history of hypersensitivity to apatinib or any of it components.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of the study is to evaluate the safety and efficacy of two different administration methods of apatinib in NSCLC patients.
Read the detailed description
- Aged ≥18；
- Locally advanced/metastatic non-small lung cancer (IIIb/IV) confirmed by pathology with measurable lesions；
- Patients with wild type EGFR/ALK must received two kinds of systemic chemotherapy before；Patients with EGFR mutation positive had experienced treatment failure with TKI in first line and Chemotherapy in second line ；
- ECOG：0-4；
- The subjects were treated with other drugs has been restored (NCI CTCAE version 4.0 class 1 or less), which accept nitroso urea or mitomycin interval 6 weeks or more; Accept other cytotoxic drugs, bevacizumab (Avastin) (except local palliative radiotherapy), radiotherapy or surgery four weeks or more. EGFR TKI ≥2 weeks; Main organs function is normal；
- Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib；
- Patients voluntarily entered the study and signed informed consent form (ICF).
- Conditions
- NSCLC Stage IV, NSCLC Stage IIIB
- Being tested
- Intervention/treatment
- Keywords
- Apatinib,NSCLC,Dose titration
- 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.
Intervention/treatmentOther
experimentalgroup initial dose：
- 250mg qod
- 250mg qd/500mg qd by turn
- 500mg qd control group： 750mg qd
| Study group | Role | What they receive |
|---|---|---|
| dose titration group | Experimental | First of all, according to the patient's weight and ECOG score, patients were divided into three groups（the initial dose of 250 mg qd,250 mg/500 mg qd by turns, 500 mg qd）. in two weeks, if the patient who is intolerant of the initial dose,250mg qod,250mg qd ,250mg qd was selected. if the patient can tolerate the dose well,a high-dose was given,and the maximum dose does not exceeding 750mg qd. Receives: Other: Intervention/treatment |
| non-titration group | Active comparator | Patients were given 750mg qd apatinib until disease progression or intolerance Receives: Other: Intervention/treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of treatment
time from take apatinib to withdrawal from experiment due to adverse reaction of apatinib
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study startAug 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Hu, Beijing Chest Hospital
- Investigators
- Li Baolan, Study director, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594682
- Sponsor's protocol ID
- HB-B001
- Status last verified
- Jun 2018
- First submitted
- 24 Jun 2018
- Last updated
- 20 Jul 2018
- 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 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Therapeutic Dose of Apatinib Mesylate Tablets in Patients With Lung Cancer by Dose Titration：A Real World Exploratory Study
- ClinicalTrials.gov ID
- NCT03594682
- Acronym / sponsor ID
- HB-B001
- Conditions
- NSCLC Stage IV, NSCLC Stage IIIB
- Keywords
- Apatinib,NSCLC,Dose titration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 20 Jul 2018 (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 purpose of the study is to evaluate the safety and efficacy of two different administration methods of apatinib in NSCLC patients.
Detailed description
- Aged ≥18；
- Locally advanced/metastatic non-small lung cancer (IIIb/IV) confirmed by pathology with measurable lesions；
- Patients with wild type EGFR/ALK must received two kinds of systemic chemotherapy before；Patients with EGFR mutation positive had experienced treatment failure with TKI in first line and Chemotherapy in second line ；
- ECOG：0-4；
- The subjects were treated with other drugs has been restored (NCI CTCAE version 4.0 class 1 or less), which accept nitroso urea or mitomycin interval 6 weeks or more; Accept other cytotoxic drugs, bevacizumab (Avastin) (except local palliative radiotherapy), radiotherapy or surgery four weeks or more. EGFR TKI ≥2 weeks; Main organs function is normal；
- Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib；
- Patients voluntarily entered the study and signed informed consent form (ICF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dose titration group | Experimental | Other: Intervention/treatmentFirst of all, according to the patient's weight and ECOG score, patients were divided into three groups（the initial dose of 250 mg qd,250 mg/500 mg qd by turns, 500 mg qd）. in two weeks, if the patient who is intolerant of the initial dose,250mg qod,250mg qd ,250mg qd was selected. if the patient can tolerate the dose well,a high-dose was given,and the maximum dose does not exceeding 750mg qd. |
| non-titration group | Active comparator | Other: Intervention/treatmentPatients were given 750mg qd apatinib until disease progression or intolerance |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥18；
- Locally advanced/metastatic non-small lung cancer (IIIb / IV) confirmed by pathology with measurable lesions ；
- Patients with wild type EGFR/ALK must received two kinds of systemic chemotherapy before；Patients with EGFR mutation positive had experienced treatment failure with TKI in first line and Chemotherapy in second line ；
- ECOG：0-4；
- The subjects were treated with other drugs has been restored (NCI CTCAE version 4.0 class 1 or less), which accept nitroso urea or mitomycin interval 6 weeks or more; Accept other cytotoxic drugs, bevacizumab (Avastin) (except local palliative radiotherapy), radiotherapy or surgery four weeks or more. EGFR TKI ≥2 weeks; Main organs function is normal；
Key exclusion criteria (17 listed)
- brain MRI, CT or venography confirmed that there are brain hemorrhage symptoms；
- Tumor invade big vessels or close to big vessels (less than 5mm)；
- Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy).；
- Patients with with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms)；
- Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy
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 |
|---|---|---|
| Intervention/treatmentexperimentalgroup initial dose： 1. 250mg qod 2. 250mg qd/500mg qd by turn 3. 500mg qd control group： 750mg qd | Other | dose titration group, non-titration group |
Primary outcome
duration of treatment
Time frame: two years
time from take apatinib to withdrawal from experiment due to adverse reaction of apatinib
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
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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 Baolan study director
Beijing Chest Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Intervention/treatment in people with NSCLC Stage IV and NSCLC Stage IIIB, run by Beijing Chest Hospital.
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 17 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 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Hu Ying (010-89509330, huying2004@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of treatment (time frame: two 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 20 Jul 2018.