Lung CancerPhase 2NCT03706703
Rh-Endostatin (Endostar®) Continuous Intravenous Infusion
A Phase 2 study testing Endostar, Docetaxel and Carboplatin in people with Lung Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.
Trial summary
Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Endostar, Docetaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 1 Sep 2020
- 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
- Primary non-small cell lung cancer confirmed by cytology and histology, excluding sputum examination;
- Phase IIIB/IV based on TNM criteria (8th);
- At least one measurable tumor based on RECIST 1.1;
- Without the known active mutation of EGFR/ALK/ROS1/RET;
- Male or female, age≥18 or ≤70 years old;
- ECOG PS: 0 or 1;
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- Estimated time of survival: ≥ 3 months;
- Suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL;
- Suitable liver function: Total bilirubin≤ normal ULN, AST and ALT≤2.5×normal ULN, ALP≤ 5×normal ULN;
- Suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min;
- EKG normal;
- Without healing wound;
- No history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrollment;
- For the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrollment;
- No history of serious allergic to biologic agents, especially E.Coli products;
- The authorized ICF must be signed.
Who cannot join
- Woman in pregnancy and breast-feeding, or having productive ability without contraception;
- Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound;
- Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension;
- Having uncontrolled nervous or mental disease with low compliance and reluctance to description of response; uncontrolled primary brain tumor or other metastatic brain cancer with obvious intracranial hypertension or mental symptoms;
- Having the tendency of bleeding, such as FIB≤2G/L;
- Being receiving adjuvant chemotherapy;
- On other conditions investigator considers, the subject is not fitful to participate the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Chuan Jin, post-graduate, 020-66673666, 18302078099@163.com
About this study
Official title: The Safety and Efficacy of Rh-Endostatin (Endostar®) Continuous Intravenous Infusion in Combination With Docetaxel/Carboplatin or Pemetrexed/Carboplatin (DC/PC) Regimens for Untreated Stage IIIB/IV Non-small-cell Lung Cancer (NSCLC)
Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.
- Conditions
- Lung Cancer
- Being tested
- Endostar, Docetaxel, Carboplatin, Pemetrexed
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndostarDrug
continuous intravenous infusion Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total.
DocetaxelDrug
docetaxel is 75 mg/m2 intravenously over 1 hour on Day 1 of each 21-day cycle
CarboplatinDrug
carboplatin is administered on Day 1 of each 21-day，followed by docetaxol or pemetrexed
PemetrexedDrug
pemetrexed is 500 mg/m2 intravenously on Days 1 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Endostar continuous intravenous infusion | Experimental | Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin Receives: Drug: Endostar; Drug: Docetaxel; Drug: Carboplatin; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
objective response rate based on Recist 1.1 edition
Measured: 8 weeks
Secondary outcomes (1)
PFS
progress free survival
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 posted16 Oct 2018
- Study start1 Oct 2018
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Sep 2020 (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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706703
- Sponsor's protocol ID
- ENDOSTAR
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2018
- Last updated
- 17 Oct 2018
- Results posted
- 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 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Rh-Endostatin (Endostar®) Continuous Intravenous Infusion in Combination With Docetaxel/Carboplatin or Pemetrexed/Carboplatin (DC/PC) Regimens for Untreated Stage IIIB/IV Non-small-cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT03706703
- Acronym / sponsor ID
- ENDOSTAR
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 16 Oct 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.
Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endostar continuous intravenous infusion | Experimental | Drug: Endostar, Drug: Docetaxel, Drug: Carboplatin, Drug: PemetrexedEndostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Primary non-small cell lung cancer confirmed by cytology and histology, excluding sputum examination;
- Phase IIIB/IV based on TNM criteria (8th);
- At least one measurable tumor based on RECIST 1.1;
- Without the known active mutation of EGFR/ALK/ROS1/RET;
- Male or female, age≥18 or ≤70 years old;
Key exclusion criteria (7 listed)
- Woman in pregnancy and breast-feeding, or having productive ability without contraception;
- Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound;
- Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension;
- Having uncontrolled nervous or mental disease with low compliance and reluctance to description of response; uncontrolled primary brain tumor or other metastatic brain cancer with obvious intracranial hypertension or mental symptoms;
- Having the tendency of bleeding, such as FIB≤2G/L;
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 |
|---|---|---|
| Endostarcontinuous intravenous infusion Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total. | Drug | Endostar continuous intravenous infusion |
| Docetaxeldocetaxel is 75 mg/m2 intravenously over 1 hour on Day 1 of each 21-day cycle | Drug | Endostar continuous intravenous infusion |
| Carboplatincarboplatin is administered on Day 1 of each 21-day，followed by docetaxol or pemetrexed | Drug | Endostar continuous intravenous infusion |
| Pemetrexedpemetrexed is 500 mg/m2 intravenously on Days 1 of each 21-day cycle | Drug | Endostar continuous intravenous infusion |
Primary outcome
ORR
Time frame: 8 weeks
objective response rate based on Recist 1.1 edition
1 secondary outcome
PFS
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 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.
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, China
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 Endostar, Docetaxel and Carboplatin in people with Lung Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical 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 16 inclusion and 7 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 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (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 17 Oct 2018.