Lung CancerPhase 2NCT03411967
Apatinib in Combination With Docetaxel for Patients With Advanced NSCLC
A Phase 2 study testing Apatinib and Docetaxel in people with Lung Cancer, run by Zigong No.1 Peoples Hospital.
Trial summary
In order to explore a new treatment strategy for patients with failed NSCLC platinum-containing double-drug therapy, this study was to investigate the clinical efficacy of apatinib in combination with docetaxel for patients with advanced NSCLC after failure of platinum-based regime Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Apatinib and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2018to 1 Dec 2021
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG 0-2;
- Expected survival of not less than 12 weeks;
- The first line of platinum-containing chemotherapy, pathologically confirmed IIIB, IV non-small cell lung cancer, with measurable lesions (according to the RECIST 1.1 standard, CT lesion tumor diameter ≥ 10mm, lymph node lesion CT scan diameter ≥ 15mm, measurable lesions have not received radiotherapy, local treatment such as freezing)
- The main organs function properly
- Women of childbearing age must have had reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and are willing to take appropriate measures 8 weeks after and during the last administration of the test drug contraception. In the case of males, consent is to be given to contraception or surgical sterilization 8 weeks after and during the last administration of the test drug;
- Participants volunteered to join the study and signed informed consent form, with good compliance and follow-up.
Who cannot join
- Imaging (CT or MRI) showed tumor lesions away from the large blood vessels ≤ 5mm, or the presence of invasive central local blood vessels of the central tumor; or showed the presence of significant lung empty or necrotic tumors;
- Uncontrolled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal drug therapy);
- Has the following cardiovascular disease: Myocardial ischemia or myocardial infarction with grade II or higher, poorly controlled arrhythmia (including QTc intercourse men ≥ 450ms, women ≥ 470ms); NYHA class III-IV cardiomyopathy, Or cardiac ultrasound examination prompted left ventricular ejection fraction (LVEF) <50%;
- Hemoptysis (INR> 1.5 or Prothrombin Time (PT)> ULN + 4 seconds or APTT> 1.5ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
- In the first 2 months before enrollment, there is obvious slightly blood, or daily hemoptysis volume of 2.5ml or more;
- Within 3 months prior to enrollment, significant clinically significant bleeding symptoms or definite bleeding tendencies such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ at baseline, and above, or vasculitis;
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- Incidence of arterial / venous thrombosis within the first 12 months of enrollment such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
- Known hereditary or acquired bleeding and thrombophilia (eg hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc);
- Factors that significantly affect the absorption of oral drugs, such as non-swallowing, chronic diarrhea and intestinal obstruction;
- Urine routine urinary protein ≥ ++, or confirmed 24-hour urinary protein content ≥ 2.0g;
- Previous or concurrent with other unhealed malignancies, except for those having had a cure for cutaneous basal cell carcinoma, carcinoma of the cervix, and superficial bladder cancer;
- Pregnant or lactating women; Reproductive patients who are unwilling or unable to take effective contraception;
- The investigators determine other situations that may affect clinical research and outcome decisions.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study of Apatinib in Combination With Docetaxel for Patients With Advanced NSCLC After Failure of Platinum-based Double-drug Therapy
In order to explore a new treatment strategy for patients with failed NSCLC platinum-containing double-drug therapy, this study was to investigate the clinical efficacy of apatinib in combination with docetaxel for patients with advanced NSCLC after failure of platinum-based regime
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Also called Aitan
apatinib mesylate tablets 500mg, po, qd, continued until the next cycle, taking on an empty stomach (daily taken at the same time), every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment, apatinib has been taken until the disease progresses, intolerable toxicity.
DocetaxelDrug
Docetaxel, 60 mg / m2, d1, iv ,every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment
| Study group | Role | What they receive |
|---|---|---|
| apatinib combine with docetaxel | Experimental | Docetaxel, 60 mg / m2, d1, iv + apatinib 500mg, po, qd Receives: Drug: Apatinib; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: 6 month
Secondary outcomes (1)
PFS
Progress-Free Survival
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Feb 2018 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zigong No.1 Peoples Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- 132100694 132100694, M.D., Principal investigator, Zigong No.1 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411967
- Sponsor's protocol ID
- APTN-L201712
- Status last verified
- Jan 2018
- First submitted
- 21 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Apatinib in Combination With Docetaxel for Patients With Advanced NSCLC After Failure of Platinum-based Double-drug Therapy
- ClinicalTrials.gov ID
- NCT03411967
- Acronym / sponsor ID
- APTN-L201712
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zigong No.1 Peoples HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 26 Jan 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.
In order to explore a new treatment strategy for patients with failed NSCLC platinum-containing double-drug therapy, this study was to investigate the clinical efficacy of apatinib in combination with docetaxel for patients with advanced NSCLC after failure of platinum-based regime
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| apatinib combine with docetaxel | Experimental | Drug: Apatinib, Drug: DocetaxelDocetaxel, 60 mg / m2, d1, iv + apatinib 500mg, po, qd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ECOG 0-2;
- Expected survival of not less than 12 weeks;
- The first line of platinum-containing chemotherapy, pathologically confirmed IIIB, IV non-small cell lung cancer, with measurable lesions (according to the RECIST 1.1 standard, CT lesion tumor diameter ≥ 10mm, lymph node lesion CT scan diameter ≥ 15mm, measurable lesions have not received radiotherapy, local treatment such as freezing)
- The main organs function properly
- Women of childbearing age must have had reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and are willing to take appropriate measures 8 weeks after and during the last administration of the test drug contraception. In the case of males, consent is to be given to contraception or surgical sterilization 8 weeks after and during the last administration of the test drug;
Key exclusion criteria (13 listed)
- Imaging (CT or MRI) showed tumor lesions away from the large blood vessels ≤ 5mm, or the presence of invasive central local blood vessels of the central tumor; or showed the presence of significant lung empty or necrotic tumors;
- Uncontrolled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal drug therapy);
- Has the following cardiovascular disease: Myocardial ischemia or myocardial infarction with grade II or higher, poorly controlled arrhythmia (including QTc intercourse men ≥ 450ms, women ≥ 470ms); NYHA class III-IV cardiomyopathy, Or cardiac ultrasound examination prompted left ventricular ejection fraction (LVEF) <50%;
- Hemoptysis (INR> 1.5 or Prothrombin Time (PT)> ULN + 4 seconds or APTT> 1.5ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
- In the first 2 months before enrollment, there is obvious slightly blood, or daily hemoptysis volume of 2.5ml or more;
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 |
|---|---|---|
| ApatinibAlso: Aitanapatinib mesylate tablets 500mg, po, qd, continued until the next cycle, taking on an empty stomach (daily taken at the same time), every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment, apatinib has been taken until the disease progresses, intolerable toxicity. | Drug | apatinib combine with docetaxel |
| DocetaxelDocetaxel, 60 mg / m2, d1, iv ,every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment | Drug | apatinib combine with docetaxel |
Primary outcome
ORR
Time frame: 6 month
Objective Response Rate
1 secondary outcome
PFS
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
132100694 132100694, M.D. principal investigator
Zigong No.1 People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib and Docetaxel in people with Lung Cancer, run by Zigong No.1 Peoples 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 6 inclusion and 13 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 26 Jan 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.
What does this phase mean?
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 Jun Yan, M.D. (868132100694, 13210069400@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 6 month). 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 26 Jan 2018.