Non-squamous Non-small Cell Lung CancerPhase 2NCT03127319
A Study of Apatinib Plus Docetaxel for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With Bone Metastases
A Phase 2 study testing apatinib docetaxel zoledronic and docetaxel zoledronic in people with Non-squamous Non-small Cell Lung Cancer, run by Affiliated Hospital of Hebei University at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus docetaxel and zoledronic versus docetaxel and zoledronic alone as second line treatment for advanced non-squamous non-small cell lung cancer with bone metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- apatinib docetaxel zoledronic and docetaxel zoledronic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2017to Dec 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age:18 to 75 years old (man or female)
- Pathologically diagnosed with metastatic or recurrent non-squamous non-small cell lung cancer
- Patients with at least one evaluate lesions of the lung and bone metastases.(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1 and WHO)
- Refractory or failure of prior therapy
- Life expectancy greater than or equal to 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
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- Major organ function has to meet the following criteria:
- For results of blood routine test (without blood transfusion within 14 days)
- HB≥90g/L
- ANC≥1.5×109/L
- PLT≥180×109/L
- For results of blood biochemical test：
- TBIL<1.5×ULN；
- ALT and AST<2.5×ULN, but< 5×ULN if the transferase elevation is due to liver metastases；
- Serum creatinine ≤1.25×ULN , or calculated creatinine clearance>45 ml/min(per the Cockcroft-Gault formula);
- Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;
- Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Who cannot join
- Allergic to apatinib and docetaxel;
- Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with class Ⅱ and above coronary heart disease, arrhythmia (including QTc lengthened men > 450 ms, women > 470 ms) and class Ⅲ-Ⅳ cardiac insufficiency;
- A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.).
- Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months; For defecate occult blood (+) and primary lesions without surgical removal of the stomach tumor, requirement of gastroscopy, such as ulcer type of gastric cancer, and researchers think that may be gastrointestinal hemorrhage;
- Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency.
- Patients with symptoms of central nervous system metastasis.
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- Pregnant or lactating women.
- history of psychiatric drugs abuse and can't quit or patients with mental disorders.
- Less than 4 weeks from the last clinical trial.
- The researchers think inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Hebei university
Baoding, Hebei
Aimin Zang, 13930881628, 15175292891@163.com
About this study
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus docetaxel and zoledronic versus docetaxel and zoledronic alone as second line treatment for advanced non-squamous non-small cell lung cancer with bone metastases.
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Being tested
- apatinib docetaxel zoledronic, docetaxel zoledronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apatinib docetaxel zoledronicDrug
apatinib 500 mg qd p.o.docetaxel 60mg/m² iv q3w;zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent
docetaxel zoledronicDrug
docetaxel 60mg/m² iv q3w;zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent
| Study group | Role | What they receive |
|---|---|---|
| apatinib and docetaxel zoledronic | Experimental | apatinib 500mg qd po; docetaxel 60mg/m² iv q3w; zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: apatinib docetaxel zoledronic |
| docetaxel zoledronic | Active comparator | docetaxel 60mg/m² iv q3w;zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: docetaxel zoledronic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: evaluation per 2 cycles (6 weeks)
Secondary outcomes (5)
Overall survival
Measured: evaluation per 2 cycles (6 weeks)
DCR (Disease control rate)
Measured: evaluation per 2 cycles (6 weeks)
ORR (Objective response rate)
Measured: evaluation per 2 cycles (6 weeks)
SREs（Skeletal-related events）
measured pain, a fracture, the need for bone radiation or surgical therapy, spinal cord compression, or hypercalcemia
Measured: evaluation per 2 cycles (6 weeks)
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Measured: evaluation per 2 cycles (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start3 Jul 2017
- Primary completionApr 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-squamous Non-small Cell 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Hebei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aimin Zang, Affiliated Hospital of Hebei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127319
- Sponsor's protocol ID
- AHHU-2017AMZ01
- Status last verified
- Jan 2017
- First submitted
- 30 Dec 2016
- Last updated
- 17 Jan 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 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Apatinib Plus Docetaxel for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With Bone Metastases
- ClinicalTrials.gov ID
- NCT03127319
- Acronym / sponsor ID
- AHHU-2017AMZ01
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Hebei UniversityUniversity, hospital or other
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 25 Apr 2017 (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 this study is to assess the efficacy and safety of patients who receive apatinib plus docetaxel and zoledronic versus docetaxel and zoledronic alone as second line treatment for advanced non-squamous non-small cell lung cancer with bone metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| apatinib and docetaxel zoledronic | Experimental | Drug: apatinib docetaxel zoledronicapatinib 500mg qd po; docetaxel 60mg/m² iv q3w; zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent |
| docetaxel zoledronic | Active comparator | Drug: docetaxel zoledronicdocetaxel 60mg/m² iv q3w;zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age:18 to 75 years old (man or female)
- Pathologically diagnosed with metastatic or recurrent non-squamous non-small cell lung cancer
- Patients with at least one evaluate lesions of the lung and bone metastases.(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1 and WHO)
- Refractory or failure of prior therapy
- Life expectancy greater than or equal to 3 months
Key exclusion criteria (10 listed)
- Allergic to apatinib and docetaxel;
- Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with class Ⅱ and above coronary heart disease, arrhythmia (including QTc lengthened men > 450 ms, women > 470 ms) and class Ⅲ-Ⅳ cardiac insufficiency;
- A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.).
- Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months; For defecate occult blood (+) and primary lesions without surgical removal of the stomach tumor, requirement of gastroscopy, such as ulcer type of gastric cancer, and researchers think that may be gastrointestinal hemorrhage;
- Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency.
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 docetaxel zoledronicapatinib 500 mg qd p.o.docetaxel 60mg/m² iv q3w;zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent | Drug | apatinib and docetaxel zoledronic |
| docetaxel zoledronicdocetaxel 60mg/m² iv q3w;zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent | Drug | docetaxel zoledronic |
Primary outcome
Progression free survival
Time frame: evaluation per 2 cycles (6 weeks)
5 secondary outcomes
Overall survival
Time frame: evaluation per 2 cycles (6 weeks)
DCR (Disease control rate)
Time frame: evaluation per 2 cycles (6 weeks)
ORR (Objective response rate)
Time frame: evaluation per 2 cycles (6 weeks)
SREs（Skeletal-related events）
Time frame: evaluation per 2 cycles (6 weeks)
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time frame: evaluation per 2 cycles (6 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 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.
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 docetaxel zoledronic and docetaxel zoledronic in people with Non-squamous Non-small Cell Lung Cancer, run by Affiliated Hospital of Hebei University 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 17 inclusion and 10 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 17 Jan 2018. 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 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 Aimin Zang (13930881628, 15175292891@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: evaluation per 2 cycles (6 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 17 Jan 2018.