Non-Small Cell Lung CancerPhase 1NCT01531790
A Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced Non Small Cell Lung Cancer Patients
A Phase 1 study testing Carboplatin, Pemetrexed and Endostar in people with Non-Small Cell Lung Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in advanced non small cell lung cancer (NSCLC) patients. 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?
- Carboplatin, Pemetrexed and Endostar
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Dec 2012
- Phase
- Phase 1
- 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
- Histological or cytological diagnosis of inoperable stage IIIB/IV non-squamous NSCLC
- At least one measurable lesion (RECIST criteria)
- Life expectancy > 3 months
- ECOG performance status 0-2
- Adequate hematologic function: WBC ≥ 3.0×109 /L，ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L
- Adequate renal, hepatic and coagulation function
- Written informed consent
Who cannot join
- With uncontrollable malignant pleural effusion or ascites
- Thoracic or abdominal surgery within 28 days prior to study entry
- History of cerebral stroke or TIA within 6 months prior to study entry
- With uncontrollable hypertension, hypertensive emergency or hypertensive encephalopathy
- Arrhythmia in need of antiarrhythmic treatment, history of angina pectoris, myocardial infarction, myocardial ischemia or congestive heart failure (> NYHA class II)
- With serious infection (> NCI CTC grade 2)
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- Gastrointestinal perforation, fistula formation, and/or intra-abdominal abscess within 6 months prior to study entry
- Symptomatic brain metastases
- Patient who has epilepsy
- History of HIV infection or chronic hepatitis B or C
- Allergic to any of the study drugs
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced NSCLC Patients
This study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in advanced non small cell lung cancer (NSCLC) patients.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Carboplatin, Pemetrexed, Endostar, Centrum
- Keywords
- Endostar, Carboplatin, Pemetrexed, NSCLC, Phase I
- 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.
CarboplatinDrug
d1, AUC 5, i.v.
PemetrexedDrug
d1, 500 mg/m2, i.v.
EndostarDrug
d2-d21, continuous Endostar intravenous infusion, 7.5 mg/m2/d, 15 mg/m2/d or 30 mg/m2/d, etc.
CentrumDrug
1 tablet/day
| Study group | Role | What they receive |
|---|---|---|
| Endostar plus pemetrexed/carboplatin | Experimental | 21 days as one cycle, for a total of 4-6 cycles Receives: Drug: Carboplatin; Drug: Pemetrexed; Drug: Endostar; Drug: Centrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Measured: up to 21 days
Secondary outcomes (4)
Objective Response Rate
Measured: up to 6 cycles
Disease Control Rate
Measured: up to 6 cycles
Progression-free Survival
Measured: up to 2 years
Overall Survival
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionDec 2012
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 Simcere Pharmaceutical 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, MD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531790
- Sponsor's protocol ID
- SIM-93
- Status last verified
- Jan 2013
- First submitted
- 7 Feb 2012
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced NSCLC Patients
- ClinicalTrials.gov ID
- NCT01531790
- Acronym / sponsor ID
- SIM-93
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Endostar, Carboplatin, Pemetrexed, NSCLC, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Feb 2012 (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.
This study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in advanced non small cell lung cancer (NSCLC) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endostar plus pemetrexed/carboplatin | Experimental | Drug: Carboplatin, Drug: Pemetrexed, Drug: Endostar, Drug: Centrum21 days as one cycle, for a total of 4-6 cycles |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological or cytological diagnosis of inoperable stage IIIB/IV non-squamous NSCLC
- At least one measurable lesion (RECIST criteria)
- Life expectancy > 3 months
- ECOG performance status 0-2
- Adequate hematologic function: WBC ≥ 3.0×109 /L，ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L
Key exclusion criteria (12 listed)
- With uncontrollable malignant pleural effusion or ascites
- Thoracic or abdominal surgery within 28 days prior to study entry
- History of cerebral stroke or TIA within 6 months prior to study entry
- With uncontrollable hypertension, hypertensive emergency or hypertensive encephalopathy
- Arrhythmia in need of antiarrhythmic treatment, history of angina pectoris, myocardial infarction, myocardial ischemia or congestive heart failure (> NYHA class II)
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 |
|---|---|---|
| Carboplatind1, AUC 5, i.v. | Drug | Endostar plus pemetrexed/carboplatin |
| Pemetrexedd1, 500 mg/m2, i.v. | Drug | Endostar plus pemetrexed/carboplatin |
| Endostard2-d21, continuous Endostar intravenous infusion, 7.5 mg/m2/d, 15 mg/m2/d or 30 mg/m2/d, etc. | Drug | Endostar plus pemetrexed/carboplatin |
| Centrum1 tablet/day | Drug | Endostar plus pemetrexed/carboplatin |
Primary outcome
Dose Limiting Toxicity
Time frame: up to 21 days
4 secondary outcomes
Objective Response Rate
Time frame: up to 6 cycles
Disease Control Rate
Time frame: up to 6 cycles
Progression-free Survival
Time frame: up to 2 years
Overall Survival
Time frame: up to 2 years
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 16 Jan 2013.
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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, MD principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Carboplatin, Pemetrexed and Endostar in people with Non-Small Cell Lung Cancer, run by Jiangsu Simcere Pharmaceutical 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 7 inclusion and 12 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 16 Jan 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Dose Limiting Toxicity (time frame: up to 21 days). 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 16 Jan 2013.