Gastric CancerPhase 2NCT03575637
Olanzapine Improves the Chemotherapy Tolerance of Advanced Gastric Cancer
A Phase 2 study testing Olanzapine in people with Gastric Cancer, run by Peking University at 1 site in China.
Trial summary
To explore whether adding olanzapine to paclitaxel chemotherapy could improve chemotherapy tolerance and improve patient quality of life and prolong treatment failure time (TTF) in advanced gastric cancer after failure of first-line chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Olanzapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Jul 2018to Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign written informed consent;
- Age more than 18 years of age;
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction;
- Locally advanced recurrent or metastatic disease;
- Have received systemic first-line chemotherapy and confirmed first-line treatment failure (platinum combined with fluorouracils);
- Subjects' baseline blood routine and biochemical indicators meet the following criteria Hemoglobin ≥90g/L The absolute neutrophil count (ANC) is ≥1.5×10^9/L. Platelets ≥100×10^9/L ALT, AST ≤ 2.5 times the normal upper limit, ≤ 5 times the normal upper limit (with liver metastasis) ALP≤2.5 times normal upper limit, ≤ 5 times normal upper limit (with liver or bone metastases) Serum total bilirubin <1.5 times normal upper limit Serum creatinine <1.5 times normal upper limit Serum albumin ≥30g/L
- KPS score ≥ 60 points;
- Life expectancy ≥ 3 months.
Who cannot join
- Does not meet the above selection criteria;
- The first-line treatment uses paclitaxel-based drugs;
- Pregnancy and lactation women;
- Allergies to research drugs or people with metabolic disorders;
- History of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation);
- Those who have been receiving systemic steroids for a long period of time (Note: Short-term users may be discontinued >2 weeks for inclusion);
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- Brain metastasis;
- With severe infections need treatment;
- Accompanied by dysphagia active peptic ulcer complete or incomplete intestinal obstruction active gastrointestinal bleeding perforation etc;
- Severe liver diseases (such as liver cirrhosis etc.) kidney disease respiratory diseases or chronic diseases such as diabetes high blood pressure that cannot be controlled;
- Having other malignant tumors within 5 years except non-melanoma skin cancer and cervical cancer in situ;
- Heart disease with markedly abnormal electrocardiogram or clinical symptoms such as congestive heart failure marked coronary heart disease uncontrolled arrhythmia high blood pressure or previous myocardial infarction within 12 months or cardiac function Class III or IV.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing
Shen Lin
About this study
Official title: Olanzapine Improves the Chemotherapy Tolerance of Advanced Gastric Cancer: a Prospective Randomized Controlled Phase II Clinical Study
To explore whether adding olanzapine to paclitaxel chemotherapy could improve chemotherapy tolerance and improve patient quality of life and prolong treatment failure time (TTF) in advanced gastric cancer after failure of first-line chemotherapy.
This is a multi-center prospective randomized controlled open clinical study. Patients will formally be enrolled after they had been screened and signed informed consent. Baseline examinations will be started after entry into the group. Those who meet the criteria for inclusion and exclusion were dynamically randomized at 1: 1. The experimental group will receive olanzapine and paclitaxel until treatment failure and the control group will receive paclitaxel until treatment failure.
- Conditions
- Gastric Cancer
- Being tested
- Olanzapine
- Keywords
- Olanzapine, Gastric Cancer, Tolerance
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Patients who have failed first-line treatment of advanced gastric cancer receive second-line treatment with paclitaxel regimen and olanzapine 5 mg QD.
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine intervention group | Experimental | Patients who have failed first-line treatment of advanced gastric cancer receive second-line treatment with paclitaxel regimen and olanzapine 5 mg QD. Receives: Drug: Olanzapine |
| Control group | No intervention | Patients who have failed first-line treatment of advanced gastric cancer receive second-line treatment with paclitaxel regimen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to treatment failure
From randomization to exit the trial, the reasons for withdrawal may be patients' refusal, disease progression, patient death, and adverse events etc.
Measured: 2 year
Secondary outcomes (2)
side effect
Incidence of nausea and vomiting; Weight change; Drug exposure; Drug cumulative dose.
Measured: 2 years
Progression free survival time (PFS), overall survival time (OS).
Progression free survival time (PFS), overall survival time (OS).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study startJul 2018 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- Shen Lin, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575637
- Sponsor's protocol ID
- Olanzapine
- Status last verified
- Jul 2018
- First submitted
- 9 Jun 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olanzapine Improves the Chemotherapy Tolerance of Advanced Gastric Cancer: a Prospective Randomized Controlled Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT03575637
- Acronym / sponsor ID
- Olanzapine
- Conditions
- Gastric Cancer
- Keywords
- Olanzapine, Gastric Cancer, Tolerance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 2 Jul 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.
To explore whether adding olanzapine to paclitaxel chemotherapy could improve chemotherapy tolerance and improve patient quality of life and prolong treatment failure time (TTF) in advanced gastric cancer after failure of first-line chemotherapy.
This is a multi-center prospective randomized controlled open clinical study. Patients will formally be enrolled after they had been screened and signed informed consent. Baseline examinations will be started after entry into the group. Those who meet the criteria for inclusion and exclusion were dynamically randomized at 1: 1. The experimental group will receive olanzapine and paclitaxel until treatment failure and the control group will receive paclitaxel until treatment failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine intervention group | Experimental | Drug: OlanzapinePatients who have failed first-line treatment of advanced gastric cancer receive second-line treatment with paclitaxel regimen and olanzapine 5 mg QD. |
| Control group | No intervention | –Patients who have failed first-line treatment of advanced gastric cancer receive second-line treatment with paclitaxel regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Sign written informed consent;
- Age more than 18 years of age;
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction;
- Locally advanced recurrent or metastatic disease;
- Have received systemic first-line chemotherapy and confirmed first-line treatment failure (platinum combined with fluorouracils);
Key exclusion criteria (12 listed)
- Does not meet the above selection criteria;
- The first-line treatment uses paclitaxel-based drugs;
- Pregnancy and lactation women;
- Allergies to research drugs or people with metabolic disorders;
- History of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation);
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 |
|---|---|---|
| OlanzapinePatients who have failed first-line treatment of advanced gastric cancer receive second-line treatment with paclitaxel regimen and olanzapine 5 mg QD. | Drug | Olanzapine intervention group |
Primary outcome
time to treatment failure
Time frame: 2 year
From randomization to exit the trial, the reasons for withdrawal may be patients' refusal, disease progression, patient death, and adverse events etc.
2 secondary outcomes
side effect
Time frame: 2 years
Progression free survival time (PFS), overall survival time (OS).
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Shen Lin principal investigator
Peking University Cancer Hospital & Institute
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 Olanzapine in people with Gastric Cancer, run by Peking 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 8 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: status not confirmed, as of the sponsor's last update on 3 Jul 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 Shen Lin (88156561, goodjf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to treatment failure (time frame: 2 year). 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 3 Jul 2018.