Malignant Pleural EffusionPhase 2NCT01327235
Endostar and/or Cisplatin for Treatment of Malignant Pleural Effusion or Ascites
A Phase 2 study testing Endostar and Cisplatin in people with Malignant Pleural Effusion and Malignant Ascites, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 3 sites in China.
Trial summary
The objective of this study is to compare the efficacy of Endostar/cisplatin with cisplatin alone or Endostar alone in patients with malignant pleural effusion or ascites. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Pleural Effusion, Malignant Ascites
- What is being tested?
- Endostar and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 3 sitesChina
- Study dates
- Mar 2011to Jul 2014
- 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
- Histological or cytological diagnosis of thoracic or abdominal tumor
- At least medium amount of malignant pleural effusion or ascites
- ECOG Performance Status 0-2
- Life expectancy ≥ 2 months
- Adequate hematologic, cardiac, renal, and hepatic function
- No major surgery within 4 weeks prior to this study
- Written informed consent
Who cannot join
- Patients with central nervous system (CNS) metastases
- Evidence of bleeding diathesis, serious infection
- Evidence of myocardial infarction, unstable angina or cardiac insufficiency
- Presence of serious COPD and/or respiratory failure
- Allergic to study drug
- Pregnant or lactating women
- Participation in other clinical trials within 30 days prior to this study
Trial locations and contacts
3 sites in 1 country.
China3 sites
The 81st Hospital of Chinese PLA
Nanjing
The Affiliated Hospital of Medical College, QingDao University
Qingdao
Fudan University Shanghai Cancer Center
Shanghai
About this study
Official title: A Randomized Controlled Multicenter Trial of Endostar and/or Cisplatin in Patients With Malignant Pleural Effusion or Ascites
The objective of this study is to compare the efficacy of Endostar/cisplatin with cisplatin alone or Endostar alone in patients with malignant pleural effusion or ascites.
- Conditions
- Malignant Pleural Effusion, Malignant Ascites
- Being tested
- Endostar, Cisplatin
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndostarDrug
intrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles
CisplatinDrug
cisplatin 40 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| Endostar | Active comparator | Not described Receives: Drug: Endostar |
| Cisplatin | Active comparator | Not described Receives: Drug: Cisplatin |
| Endostar and Cisplatin | Experimental | Not described Receives: Drug: Endostar; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
WHO criteria
Measured: baseline to measured progressive disease, every three weeks
Secondary outcomes (3)
Time to Progression
Measured: baseline to every three weeks until disease progression
Quality of Life
Measured: baseline to every three weeks
Incidence of Adverse Events
Measured: Up to 1 month after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionStudies 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
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shukui Qin, MD, Principal investigator, The 81st Hospital of Chinese PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327235
- Sponsor's protocol ID
- SIM-90
- Status last verified
- Jul 2014
- First submitted
- 28 Mar 2011
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multicenter Trial of Endostar and/or Cisplatin in Patients With Malignant Pleural Effusion or Ascites
- ClinicalTrials.gov ID
- NCT01327235
- Acronym / sponsor ID
- SIM-90
- Conditions
- Malignant Pleural Effusion, Malignant Ascites
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 1 Apr 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 objective of this study is to compare the efficacy of Endostar/cisplatin with cisplatin alone or Endostar alone in patients with malignant pleural effusion or ascites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endostar | Active comparator | Drug: Endostar |
| Cisplatin | Active comparator | Drug: Cisplatin |
| Endostar and Cisplatin | Experimental | Drug: Endostar, Drug: Cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological or cytological diagnosis of thoracic or abdominal tumor
- At least medium amount of malignant pleural effusion or ascites
- ECOG Performance Status 0-2
- Life expectancy ≥ 2 months
- Adequate hematologic, cardiac, renal, and hepatic function
Key exclusion criteria (7 listed)
- Patients with central nervous system (CNS) metastases
- Evidence of bleeding diathesis, serious infection
- Evidence of myocardial infarction, unstable angina or cardiac insufficiency
- Presence of serious COPD and/or respiratory failure
- Allergic to study drug
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 |
|---|---|---|
| Endostarintrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles | Drug | Endostar, Endostar and Cisplatin |
| Cisplatincisplatin 40 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles | Drug | Cisplatin, Endostar and Cisplatin |
Primary outcome
Objective Response Rate
Time frame: baseline to measured progressive disease, every three weeks
WHO criteria
3 secondary outcomes
Time to Progression
Time frame: baseline to every three weeks until disease progression
Quality of Life
Time frame: baseline to every three weeks
Incidence of Adverse Events
Time frame: Up to 1 month after the last treatment
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 1 Aug 2014.
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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.
Shukui Qin, MD principal investigator
The 81st Hospital of Chinese PLA
3 sites 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 and Cisplatin in people with Malignant Pleural Effusion and Malignant Ascites, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 3 sites 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 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: finished, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Objective Response Rate (time frame: baseline to measured progressive disease, every three 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 1 Aug 2014.