Brain MetastasesPhase 2NCT01410370
Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases
A Phase 2 study testing 6MV-X ray and Endostar in people with Brain Metastases, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The aim of this study is to evaluate the clinical efficacy and safety of continuous Endostar infusion combined with radiotherapy for treatment of brain metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Metastases
- What is being tested?
- 6MV-X ray and Endostar
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Jun 2013
- 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
- Histologically confirmed malignancy with presence of intraparenchymal brain metastases
- Karnofsky performance status ≥ 40
- Measurable disease according to RECIST criteria
- Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L
- Renal function: Cr ≤ 2.0×ULN
- Hepatic function: BIL ≤ 2.0×ULN, ALT/AST ≤ 5.0×ULN
- Adequate cardiac function
- Life expectancy ≥ 3 months
Who cannot join
- Evidence of bleeding diathesis or serious infection
- Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
- Uncontrollable mental and nervous disorders
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Xiaodong Jiang, MD contact
China1 site, 1 recruiting
- Recruiting
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222002
Xiaodong Jiang, MD, 0518-85605120
About this study
Official title: Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy for the Treatment of Patients With Brain Metastases
The aim of this study is to evaluate the clinical efficacy and safety of continuous Endostar infusion combined with radiotherapy for treatment of brain metastases.
- Conditions
- Brain Metastases
- Being tested
- 6MV-X ray, Endostar
- Keywords
- Endostar, Radiotherapy, Brain Metastases
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6MV-X rayRadiation
3Gy/time, 5 times/week, a total of 10 times
EndostarDrug
7.5mg/m2/d, continuous infusion, in parallel with radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Radiotherapy plus Endostar Receives: Radiation: 6MV-X ray; Drug: Endostar |
| control | Active comparator | Radiotherapy Receives: Radiation: 6MV-X ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: 1 month after initial treatment
Secondary outcomes (5)
Overall Survival
Measured: 2 year
Serum VEGF Levels
Measured: at baseline and 1 month after initial treatment
VEGF levels in tumor tissue
Measured: at baseline and 1 month after initial treatment
Incidence of Adverse Events
Measured: up to 1 month after last dose
Cerebral Edema
Measured: 1 month after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First People's Hospital of Lianyungang
- Investigators
- Xiaodong Jiang, MD, Principal investigator, The First People's Hospital of Lianyungang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410370
- Sponsor's protocol ID
- Endu-201107
- Status last verified
- Apr 2013
- First submitted
- 20 Jul 2011
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy for the Treatment of Patients With Brain Metastases
- ClinicalTrials.gov ID
- NCT01410370
- Acronym / sponsor ID
- Endu-201107
- Conditions
- Brain Metastases
- Keywords
- Endostar, Radiotherapy, Brain Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First People's Hospital of Lianyungang
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 5 Aug 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.
The aim of this study is to evaluate the clinical efficacy and safety of continuous Endostar infusion combined with radiotherapy for treatment of brain metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Radiation: 6MV-X ray, Drug: EndostarRadiotherapy plus Endostar |
| control | Active comparator | Radiation: 6MV-X rayRadiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed malignancy with presence of intraparenchymal brain metastases
- Karnofsky performance status ≥ 40
- Measurable disease according to RECIST criteria
- Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L
- Renal function: Cr ≤ 2.0×ULN
Key exclusion criteria (4 listed)
- Evidence of bleeding diathesis or serious infection
- Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
- Uncontrollable mental and nervous disorders
- Pregnant or lactating women
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 |
|---|---|---|
| 6MV-X ray3Gy/time, 5 times/week, a total of 10 times | Radiation | control, treatment |
| Endostar7.5mg/m2/d, continuous infusion, in parallel with radiotherapy | Drug | treatment |
Primary outcome
Objective Response Rate (ORR)
Time frame: 1 month after initial treatment
5 secondary outcomes
Overall Survival
Time frame: 2 year
Serum VEGF Levels
Time frame: at baseline and 1 month after initial treatment
VEGF levels in tumor tissue
Time frame: at baseline and 1 month after initial treatment
Incidence of Adverse Events
Time frame: up to 1 month after last dose
Cerebral Edema
Time frame: 1 month after initial treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 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.
Xiaodong Jiang, MD contact
Xiaodong Jiang, MD principal investigator
The First People's Hospital of Lianyungang
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 6MV-X ray and Endostar in people with Brain Metastases, 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 8 inclusion and 4 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 24 Apr 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 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 Xiaodong Jiang, MD (86-0518-85605120), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 1 month after initial treatment). 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 24 Apr 2013.