Non-Small-Cell Lung CancerPhase 2NCT01270386
A Study of Apatinib in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
A Phase 2 study testing apatinib in people with Non-Small-Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. Phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- apatinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to Sep 2011
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 and ≤ 70 years of age
- Histologically or cytologic confirmed advanced non-squamous and non-small cell lung cancer.
- At least one measurable lesion which has not received radiotherapy (larger than 10 mm in diameter by spiral CT scan)
- Have failed for 2 lines of chemotherapy including EGFR-TKI.
- ECOG performance scale 0 - 1.
- Life expectancy of more than 3 months.
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- Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
- More than 4 weeks after operation or radiotherapy
- More than 4 weeks for cytotoxic agents or tyrosine kinase inhibitors inhibitors
- Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min,
- signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Who cannot join
- Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer (including small cell and non-small cell mixed lung cancer)
- Pregnant or breastfeeding women
- Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
- Any factors that influence the usage of oral administration
- PT, APTT, TT, Fbg abnormal, Receiving the therapy of thrombolysis or anticoagulation.
- Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3).
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- Long-term untreated wounds or fractures.
- Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
- Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues; If the prothrombin time international normalized ratio (INR) ≤ 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) or low-dose aspirin (between 80mg to 100mg daily) is allowed.
- Abuse of alcohol or drugs
- Less than 4 weeks from the last clinical trial
- Treatment with VEGFR, PDGFR, sSRC-TKI before.
- History of any second malignancies within 3 years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Medical Oncology, Cancer Center, Sun Yet-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Multicenter, Phase II Study of Apatinib as Third Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. Phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival compared with placebo in patients with advanced non-squamous and non-small cell lung cancer who failed two lines of chemotherapy.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- apatinib, placebo
- Keywords
- NSCLC, apatinib, phase II, lung, cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apatinibDrug
Apatinib 750 mg p.o. once daily
placeboDrug
placebo p.o. once daily
| Study group | Role | What they receive |
|---|---|---|
| Apatinib | Experimental | Apatinib 750 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: apatinib |
| Placebo | Placebo comparator | Placebo qd p.o., and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 8 weeks
Secondary outcomes (5)
Overall Survival safety
Measured: 8 weeks
DCR(Disease control rate)
Measured: 8 weeks
ORR(objective response rate)
Measured: 8 weeks
QoL(quality of life)
Measured: 8 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Investigators
- Li Zhang, Dr, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270386
- Sponsor's protocol ID
- HENGRUI 20101219
- Status last verified
- Feb 2012
- First submitted
- 29 Dec 2010
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Multicenter, Phase II Study of Apatinib as Third Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01270386
- Acronym / sponsor ID
- HENGRUI 20101219
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- NSCLC, apatinib, phase II, lung, cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Study start
- Mar 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 5 Jan 2011 (estimated)
- 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.
Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. Phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival compared with placebo in patients with advanced non-squamous and non-small cell lung cancer who failed two lines of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib | Experimental | Drug: apatinibApatinib 750 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
| Placebo | Placebo comparator | Drug: placeboPlacebo qd p.o., and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥ 18 and ≤ 70 years of age
- Histologically or cytologic confirmed advanced non-squamous and non-small cell lung cancer.
- At least one measurable lesion which has not received radiotherapy (larger than 10 mm in diameter by spiral CT scan)
- Have failed for 2 lines of chemotherapy including EGFR-TKI.
- ECOG performance scale 0 - 1.
Key exclusion criteria (13 listed)
- Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer (including small cell and non-small cell mixed lung cancer)
- Pregnant or breastfeeding women
- Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
- Any factors that influence the usage of oral administration
- PT, APTT, TT, Fbg abnormal, Receiving the therapy of thrombolysis or anticoagulation.
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 |
|---|---|---|
| apatinibApatinib 750 mg p.o. once daily | Drug | Apatinib |
| placeboplacebo p.o. once daily | Drug | Placebo |
Primary outcome
Progression free survival
Time frame: 8 weeks
5 secondary outcomes
Overall Survival safety
Time frame: 8 weeks
DCR(Disease control rate)
Time frame: 8 weeks
ORR(objective response rate)
Time frame: 8 weeks
QoL(quality of life)
Time frame: 8 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2012.
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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, Dr 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 2 study testing apatinib in people with Non-Small-Cell Lung Cancer, 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 11 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: finished, as of the sponsor's last update on 10 Feb 2012. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 8 weeks). 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 2012.