HER2-negative Advanced Gastric CancerPhase 1NCT05171530
Lenvatinib With Taxane Drugs Treatment for Advanced Gastric Cancer
A Phase 1 study testing Lenvatinib plus taxane drugs in people with HER2-negative Advanced Gastric Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to study the safety and efficacy of lenvatinib combined with single-agent taxanes therapy in patients with HER2-negative advanced gastric cancer that have failed at the standard first-line therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-negative Advanced Gastric Cancer
- What is being tested?
- Lenvatinib plus taxane drugs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2022to 30 Jun 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to provide written informed consent.
- Advanced gastric cancer diagnosed by histopathological or cytological examination, no uncontrollable pleural and ascites;.
- Age no less than 18 years.
- Life expectancy greater than 3 months.
- According to the RECIST (Response Evaluation Criteria in Solid Tumors) standard, there must be measurable lesions.
- Failed at the standard first-line therapy, microsatellite stable (MSS) or no mismatch repair missing(PMMR), HER2 negative.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 .
- Adequate liver/bone marrow function.
- Female subjects must meet the following conditions: infertility or fertility and use high-efficiency contraceptive measures.
- Male subjects agree to use approved contraceptive methods (e.g. birth control pills, barrier device, intrauterine device, abstinence) during the study and for 3 months following the last dose of the study cell infusion. Moreover, all men are absolutely prohibited from donating sperm within 1 year after receiving the last study treatment infusion.
Who cannot join
- Previous use of lenvatinib or chemotherapy drugs in the regimen.
- Pregnant or breast-feeding female, or not willing to take contraception measures during study.
- Uncontrolled brain metastasis or mental illness.
- Suffered from other uncured malignant tumors within the past 3 years or at the same time.
- A history of active gastrointestinal bleeding within 3 months, incomplete obstruction or complete intestinal obstruction.
- Uncontrollable high blood pressure are not suitable for enroll into the study.
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- Other uncontrolled diseases may cause abnormal death of the patient.
- Untolerable liver/bone marrow function.
- Factors that affect the administration of oral drugs (dysphagia, chronic diarrhea, complete intestinal obstruction, etc.
- Previously allergic to the ingredients of the medicine in regimen.
- Can't be followed up or obey protocol.
- The investigator believes that it is not appropriate to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Yan Shi, 13810561979, sy_rjh@aliyun.com
About this study
Official title: An Exploratory Clinical Study of Lenvatinib Combined With Single-agent Taxanes as Second-line Therapy for the Treatment of HER2-negative Advanced Gastric Cancer
The goal of this clinical trial is to study the safety and efficacy of lenvatinib combined with single-agent taxanes therapy in patients with HER2-negative advanced gastric cancer that have failed at the standard first-line therapy.
Read the detailed description
This study is being conducted to establish safety and preliminary efficacy of Lenvatinib plus taxane drugs treatment for HER2-negative advanced gastric cancer after failure of first-line treatment.
The study will adopt the "3+3" dose escalation design. All patients received a standard dose of chemotherapy: paclitaxel 135mg/m2 every 3 weeks or docetaxel 75mg/m2 every 3 weeks. Lenvatinib is exploring four doses of 4mg, 8mg, 12mg, and 16mg, orally once a day every 3 weeks. In the first cycle, lenvatinib was administered 5 days before chemotherapy，once a day. Chemotherapy lasts up to 6 cycles, and lenvatinib continues to be administered until the disease progresses, intolerable side effects, or death.
In order to avoid the possible ineffectiveness caused by the patient being exposed to low doses, the initial dose of 4 mg was enrolled in 1 patient. If there is no obvious dose-limiting toxicity (DLT) after the first dose, the dose escalation adopts a "3+3" method from the 8mg dose: if none of the 3 subjects in the previous dose group has a DLT within 21 days, the next dose study will be carried out; if one subject in the group has DLT occurs, then 3 additional subjects should be added to the dose group; if the 3 subjects have 1 or more DLTs, the trial terminated and the previous dose was regarded as the maximum tolerated dose (MTD).
- Conditions
- HER2-negative Advanced Gastric Cancer
- Being tested
- Lenvatinib plus taxane drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenvatinib plus taxane drugsDrug
- Drug: Paclitaxel Dose: 135mg/m2 Other Name: PTX
- Drug: Docetaxel Dose: 75mg/m2 Other Name: FA
- Drug: Lenvatinib Dose: 4mg, 8mg, 12mg,16mg Other Name: FA
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib with taxane drugs treatment for advanced gastric cancer | Experimental | Experimental: Lenvatinib plus taxane drugs The subjects in this arm will receive a Lenvatinib combined with single-agent taxanes therapy. A standard dose of chemotherapy: paclitaxel 135mg/m2 every 3 weeks or docetaxel 75mg/m2 every 3 weeks will be administrated. Lenvatinib is exploring four doses of 4mg, 8mg, 12mg, and 16mg, orally once a day every 3 weeks. In the first cycle, lenvatinib was administered 5 days before chemotherapy，once a day. Chemotherapy lasts up to 6 cycles, and lenvatinib continues to be administered until the disease progresses, intolerable side effects, or death.
Subjects will be enrolled serially. For subject safety, the preceding subject must have completed therapy and there is no obvious DLT within 21 days before the next subject can be treated.
Interventions:
* Drug: Paclitaxel or Docetaxel
* Drug: Lenvatinib Receives: Drug: Lenvatinib plus taxane drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence of DLT within 21 days of the first Lenvatinib application
Measured: 4 weeks after the last administration
Incidence of Treatment Related adverse events (TRAEs)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 4 weeks after the last administration
Incidence of dose-limiting toxicities (DLTs)
All patients who have received at least one dose of treatment will be included in the safety analysis. Number of participants with dose-limiting toxicities as assessed by CTCAE v5.0
Measured: 4 weeks after the last administration
Incidence of Treatment Emergent Adverse Event (TEAEs)
Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0
Measured: 4 weeks after the last administration
Maximum tolerated dose of lenvatinib
Maximum tolerated dose of lenvatinib in combination with single-agent chemotherapy
Measured: 4 weeks after the last administration
Secondary outcomes (5)
Objective response rate (ORR)
Objective Response Rate is defined as the percentage of patients with a documented complete response or partial response (CR + PR) based on RECIST v1.1.
Measured: up to 12 months
Disease control rate (DCR) based on the researcher's evaluation
Disease control Rate is defined as the percentage of patients with a documented complete response or partial response or stable disease (CR + PR+SD) based on RECIST v1.1.
Measured: up to 12 months
Duration of Remission (DOR) based on the researcher's evaluation
The duration of remission (DOR) is defined as the time interval between the subject's first recording of disease remission to the first recording of disease progression.
Measured: up to 12 months
Progression-free survival (PFS) based on the researcher's evaluation
Progression-free survival (PFS) is defined as the time interval from the first treatment of the subject to the first recording of disease progression or death due to any cause, whichever occurs first.
Measured: up to 12 months
Overall survival (OS)
Overall survival is defined as the time from signing ICF until death from any cause.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start5 Jan 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-negative Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Shi, Ruijin Hospital
- Investigators
- Yan Shi, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171530
- Sponsor's protocol ID
- LOGIC
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2021
- Last updated
- 29 Dec 2021
- 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 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Lenvatinib Combined With Single-agent Taxanes as Second-line Therapy for the Treatment of HER2-negative Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT05171530
- Acronym / sponsor ID
- LOGIC
- Conditions
- HER2-negative Advanced Gastric Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 5 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 29 Dec 2021 (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.
The goal of this clinical trial is to study the safety and efficacy of lenvatinib combined with single-agent taxanes therapy in patients with HER2-negative advanced gastric cancer that have failed at the standard first-line therapy.
Detailed description
This study is being conducted to establish safety and preliminary efficacy of Lenvatinib plus taxane drugs treatment for HER2-negative advanced gastric cancer after failure of first-line treatment.
The study will adopt the "3+3" dose escalation design. All patients received a standard dose of chemotherapy: paclitaxel 135mg/m2 every 3 weeks or docetaxel 75mg/m2 every 3 weeks. Lenvatinib is exploring four doses of 4mg, 8mg, 12mg, and 16mg, orally once a day every 3 weeks. In the first cycle, lenvatinib was administered 5 days before chemotherapy，once a day. Chemotherapy lasts up to 6 cycles, and lenvatinib continues to be administered until the disease progresses, intolerable side effects, or death.
In order to avoid the possible ineffectiveness caused by the patient being exposed to low doses, the initial dose of 4 mg was enrolled in 1 patient. If there is no obvious dose-limiting toxicity (DLT) after the first dose, the dose escalation adopts a "3+3" method from the 8mg dose: if none of the 3 subjects in the previous dose group has a DLT within 21 days, the next dose study will be carried out; if one subject in the group has DLT occurs, then 3 additional subjects should be added to the dose group; if the 3 subjects have 1 or more DLTs, the trial terminated and the previous dose was regarded as the maximum tolerated dose (MTD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib with taxane drugs treatment for advanced gastric cancer | Experimental | Drug: Lenvatinib plus taxane drugsExperimental: Lenvatinib plus taxane drugs The subjects in this arm will receive a Lenvatinib combined with single-agent taxanes therapy. A standard dose of chemotherapy: paclitaxel 135mg/m2 every 3 weeks or docetaxel 75mg/m2 every 3 weeks will be administrated. Lenvatinib is exploring four doses of 4mg, 8mg, 12mg, and 16mg, orally once a day every 3 weeks. In the first cycle, lenvatinib was administered 5 days before chemotherapy，once a day. Chemotherapy lasts up to 6 cycles, and lenvatinib continues to be administered until the disease progresses, intolerable side effects, or death. Subjects will be enrolled serially. For subject safety, the preceding subject must have completed therapy and there is no obvious DLT within 21 days before the next subject can be treated. Interventions: * Drug: Paclitaxel or Docetaxel * Drug: Lenvatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ability to understand and the willingness to provide written informed consent.
- Advanced gastric cancer diagnosed by histopathological or cytological examination, no uncontrollable pleural and ascites;.
- Age no less than 18 years.
- Life expectancy greater than 3 months.
- According to the RECIST (Response Evaluation Criteria in Solid Tumors) standard, there must be measurable lesions.
Key exclusion criteria (12 listed)
- Previous use of lenvatinib or chemotherapy drugs in the regimen.
- Pregnant or breast-feeding female, or not willing to take contraception measures during study.
- Uncontrolled brain metastasis or mental illness.
- Suffered from other uncured malignant tumors within the past 3 years or at the same time.
- A history of active gastrointestinal bleeding within 3 months, incomplete obstruction or complete intestinal obstruction.
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 |
|---|---|---|
| Lenvatinib plus taxane drugs* Drug: Paclitaxel Dose: 135mg/m2 Other Name: PTX * Drug: Docetaxel Dose: 75mg/m2 Other Name: FA * Drug: Lenvatinib Dose: 4mg, 8mg, 12mg,16mg Other Name: FA | Drug | Lenvatinib with taxane drugs treatment for advanced gastric cancer |
Primary outcome
Adverse events
Time frame: 4 weeks after the last administration
Incidence of DLT within 21 days of the first Lenvatinib application
Incidence of Treatment Related adverse events (TRAEs)
Time frame: 4 weeks after the last administration
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Incidence of dose-limiting toxicities (DLTs)
Time frame: 4 weeks after the last administration
All patients who have received at least one dose of treatment will be included in the safety analysis. Number of participants with dose-limiting toxicities as assessed by CTCAE v5.0
Incidence of Treatment Emergent Adverse Event (TEAEs)
Time frame: 4 weeks after the last administration
Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0
Maximum tolerated dose of lenvatinib
Time frame: 4 weeks after the last administration
Maximum tolerated dose of lenvatinib in combination with single-agent chemotherapy
5 secondary outcomes
Objective response rate (ORR)
Time frame: up to 12 months
Disease control rate (DCR) based on the researcher's evaluation
Time frame: up to 12 months
Duration of Remission (DOR) based on the researcher's evaluation
Time frame: up to 12 months
Progression-free survival (PFS) based on the researcher's evaluation
Time frame: up to 12 months
Overall survival (OS)
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- 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.
Yan Shi principal investigator
Ruijin Hospital
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 Lenvatinib plus taxane drugs in people with HER2-negative Advanced Gastric Cancer, run by Ruijin Hospital 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 10 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 29 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Shi (13810561979, sy_rjh@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 4 weeks after the last administration). The study lists 5 primary outcomes in all. 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 29 Dec 2021.