To Evaluate the Effectiveness of GM1 in the Prevention of Albumin-paclitaxel Therapy Induced Peripheral Neuropathy in Breast Cancer PatientsPhase 2/3NCT05802342
A Multicenter, Randomized, Double-blind Phase II Trial to Evaluate GM1 Prevention of Peripheral Neuropathy in Patients With Breast Cancer
A Phase 2/3 study testing Monosialotetrahexose ganglioside sodium injection in people with To Evaluate the Effectiveness of GM1 in the Prevention of Albumin-paclitaxel Therapy Induced Peripheral Neuropathy in Breast Cancer Patients, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
This randomized, double-blind, multicenter, placebo-controlled Phase II trial was designed to investigate the efficacy and safety of GM1 in the prevention of peripheral neuropathy caused by albumin-bound paclitaxel regimen in breast cancer patients.This study was randomly divided into 3 groups at 1:1:1 with 50… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- To Evaluate the Effectiveness of GM1 in the Prevention of Albumin-paclitaxel Therapy Induced Peripheral Neuropathy in Breast Cancer Patients
- What is being tested?
- Monosialotetrahexose ganglioside sodium injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2023to 31 Dec 2025
- Phase
- Phase 2/3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand the content of the experiment and voluntarily sign the informed consent;
- Age from 18 to 75 years old (including both ends);
- Breast cancer patients who provide definitive histological and/or cytological diagnosis of breast cancer and are proposing adjuvant/neoadjuvant therapy with the albumin-paclitaxel regimen;
- ECOG score 0~1;
- The organ function level must meet the requirements
- Subjects (both male and female) agreed to use effective contraception from the time of signing the informed consent to 30 days after the last use of the study drug. Female subjects of childbearing age cannot be pregnant or lactating.
- Patients can accurately record or express the occurrence and severity of neurotoxicity in questionnaires;
- After enrollment, patients should not receive other treatments or care that might prevent or treat neurotoxic adverse events
Who cannot join
- Presence of grade 1 peripheral neurotoxicity (CTCAE≥1) or symptoms of peripheral neuropathy (FACT/GOG-Ntx≥1)
- There are risk factors for peripheral neuropathy (except peripheral neuropathy caused by chemotherapy),Including but not limited to: diabetic peripheral neuropathy; Peripheral vascular disease; Folic acid, B12 vitamin deficiency; Postoperative neuropathy; Post-traumatic neuropathy; Peripheral neuroinflammatory lesions; Peripheral neuropathy caused by tumor compression and infiltration; Other researchers believe that can cause limb pain, numbness, paresthesia, dysfunction of the skin, muscle, vascular diseases;
- Cardiovascular and cerebrovascular diseases, including but not limited to: Myocardial infarction (within 6 months before signing the informed consent), unstable angina, high risk of uncontrollable arrhythmia, coronary artery bypass grafting, cerebrovascular accident (within 6 months before signing the informed consent), congestive heart failure (cardiac function grade III-Ⅳ), pulmonary embolism, deep vein thrombosis, and other cardiovascular and cerebrovascular systems deemed unsuitable for inclusion by the investigator General disease;
- Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) after optimal treatment with antihypertensive drugs; Patients with blood pressure deemed unsuitable for clinical trials by the investigator;
- Diabetic patients with HBA1c ≥9.0%;
- Active bacterial, fungal, or viral infections that require systematic treatment within one week prior to initial administration; Infectious diarrhea occurred within 4 weeks prior to initial administration;
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- History of inherited abnormal glucose and lipid metabolism (ganglioside accumulation disease, such as familial amaurosis, retinal degeneration) or autoimmune disease;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); Syphilis antibody positive;
- Active hepatitis B (HBsAg positive with HBV-DNA > 500 IU/ml or lower limit of Center detection [only when lower limit of Center detection is higher than 500 IU/ml]), active hepatitis C (patients with HCV antibody positive but HCV-RNA < lower limit of Center detection are admitted);
- Known allergy to ganglioside drugs or any excipient component of such products; Or to treat an allergy to a drug or any excipient component of such product;
- Patients who, in the judgment of the investigator, may increase the risk associated with the study, may interfere with the interpretation of the study results, or may be deemed unsuitable for inclusion by the investigator and/or sponsor.
About this study
Official title: a Multicenter, Randomized, Double-blind Phase II Trial To Evaluate Monosialate Tetrahexose-ganglioside Sodium Injection (GM1) for Prevention of Peripheral Neuropathy in Patients With Breast Cancer Induced by Albumin-bound Paclitaxel Regimen Adjuvant/Neoadjuvant Therapy
This randomized, double-blind, multicenter, placebo-controlled Phase II trial was designed to investigate the efficacy and safety of GM1 in the prevention of peripheral neuropathy caused by albumin-bound paclitaxel regimen in breast cancer patients.This study was randomly divided into 3 groups at 1:1:1 with 50 subjects in each group Subjects received study treatment until the end of treatment for a total of 4/6 cycles. The treatment period was GM1/ placebo combined with albumin-bound paclitaxel therapy. GM1 / placebo was administered 1 day before administration (D0), on the day of administration (D1) and on the day after administration (D2), and albumin-bound paclitaxel was administered starting on day D1, with a total of 4/6 cycles.
- Being tested
- Monosialotetrahexose ganglioside sodium injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monosialotetrahexose ganglioside sodium injectionDrug
The treatment period was GM1/ placebo with albumin-paclitaxel from cycle 1 to cycle 4/6. The treatment period was GM1/ placebo with albumin-paclitaxel. GM1/ placebo was administered every 2 weeks /3 weeks. GM1 / placebo was administered 1 day before administration (D0), on the day of administration (D1) and on the day after administration (D2), and albumin-paclitaxel-based chemotherapy was administered from day 1, with a total of 4/6 cycles of administration. GM1/ placebo was administered every 2 weeks /3 weeks. GM1 / placebo was administered 1 day before administration (D0), on the day of administration (D1) and on the day after administration (D2), and albumin-paclitaxel-based chemotherapy was administered from day 1, with a total of 4/6 cycles of administration.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | GM1 (100 mg) + albumin paclitaxel Receives: Drug: Monosialotetrahexose ganglioside sodium injection |
| B | Experimental | GM1 (400 mg) + albumin paclitaxel Receives: Drug: Monosialotetrahexose ganglioside sodium injection |
| C | Placebo comparator | placebo + albumin paclitaxel Receives: Drug: Monosialotetrahexose ganglioside sodium injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade ≥2 neurotoxicity （CTCAE）
Measured: C4D3
The difference between the FACT/GOG-Ntx score and the baseline score
Measured: C4D3
Secondary outcomes (4)
The incidence of peripheral neurotoxicity during cycles 1 to 6 and follow-up
Measured: 12 month
Change in FACT/GOG-Ntx scores from baseline during 1-6 cycles and follow-up
Measured: 12 month
Change in CIPN20 score from baseline after 1-6 cycles and follow-up
Measured: 12 month
incidence of adverse events
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start20 Apr 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate the Effectiveness of GM1 in the Prevention of Albumin-paclitaxel Therapy Induced Peripheral Neuropathy in Breast Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Qilu 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was randomly divided into 3 groups at 1:1:1 with 50 subjects in each group. The treatment plan was as follows. Group A: GM1 (100 mg) + albumin paclitaxel; Group B: GM1 (400 mg) + albumin paclitaxel; Group C: placebo + albumin paclitaxel;
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802342
- Sponsor's protocol ID
- GM1-CIPN-202
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 6 Apr 2023
- 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 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Multicenter, Randomized, Double-blind Phase II Trial To Evaluate Monosialate Tetrahexose-ganglioside Sodium Injection (GM1) for Prevention of Peripheral Neuropathy in Patients With Breast Cancer Induced by Albumin-bound Paclitaxel Regimen Adjuvant/Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT05802342
- Acronym / sponsor ID
- GM1-CIPN-202
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Apr 2023 (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.
This randomized, double-blind, multicenter, placebo-controlled Phase II trial was designed to investigate the efficacy and safety of GM1 in the prevention of peripheral neuropathy caused by albumin-bound paclitaxel regimen in breast cancer patients.This study was randomly divided into 3 groups at 1:1:1 with 50 subjects in each group Subjects received study treatment until the end of treatment for a total of 4/6 cycles. The treatment period was GM1/ placebo combined with albumin-bound paclitaxel therapy. GM1 / placebo was administered 1 day before administration (D0), on the day of administration (D1) and on the day after administration (D2), and albumin-bound paclitaxel was administered starting on day D1, with a total of 4/6 cycles.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study was randomly divided into 3 groups at 1:1:1 with 50 subjects in each group. The treatment plan was as follows. Group A: GM1 (100 mg) + albumin paclitaxel; Group B: GM1 (400 mg) + albumin paclitaxel; Group C: placebo + albumin paclitaxel;
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Monosialotetrahexose ganglioside sodium injectionGM1 (100 mg) + albumin paclitaxel |
| B | Experimental | Drug: Monosialotetrahexose ganglioside sodium injectionGM1 (400 mg) + albumin paclitaxel |
| C | Placebo comparator | Drug: Monosialotetrahexose ganglioside sodium injectionplacebo + albumin paclitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Fully understand the content of the experiment and voluntarily sign the informed consent;
- Age from 18 to 75 years old (including both ends);
- Breast cancer patients who provide definitive histological and/or cytological diagnosis of breast cancer and are proposing adjuvant/neoadjuvant therapy with the albumin-paclitaxel regimen;
- ECOG score 0~1;
- The organ function level must meet the requirements
Key exclusion criteria (11 listed)
- Presence of grade 1 peripheral neurotoxicity (CTCAE≥1) or symptoms of peripheral neuropathy (FACT/GOG-Ntx≥1)
- There are risk factors for peripheral neuropathy (except peripheral neuropathy caused by chemotherapy),Including but not limited to: diabetic peripheral neuropathy; Peripheral vascular disease; Folic acid, B12 vitamin deficiency; Postoperative neuropathy; Post-traumatic neuropathy; Peripheral neuroinflammatory lesions; Peripheral neuropathy caused by tumor compression and infiltration; Other researchers believe that can cause limb pain, numbness, paresthesia, dysfunction of the skin, muscle, vascular diseases;
- Cardiovascular and cerebrovascular diseases, including but not limited to: Myocardial infarction (within 6 months before signing the informed consent), unstable angina, high risk of uncontrollable arrhythmia, coronary artery bypass grafting, cerebrovascular accident (within 6 months before signing the informed consent), congestive heart failure (cardiac function grade III-Ⅳ), pulmonary embolism, deep vein thrombosis, and other cardiovascular and cerebrovascular systems deemed unsuitable for inclusion by the investigator General disease;
- Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) after optimal treatment with antihypertensive drugs; Patients with blood pressure deemed unsuitable for clinical trials by the investigator;
- Diabetic patients with HBA1c ≥9.0%;
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 |
|---|---|---|
| Monosialotetrahexose ganglioside sodium injectionThe treatment period was GM1/ placebo with albumin-paclitaxel from cycle 1 to cycle 4/6. The treatment period was GM1/ placebo with albumin-paclitaxel. GM1/ placebo was administered every 2 weeks /3 weeks. GM1 / placebo was administered 1 day before administration (D0), on the day of administration (D1) and on the day after administration (D2), and albumin-paclitaxel-based chemotherapy was administered from day 1, with a total of 4/6 cycles of administration. GM1/ placebo was administered every 2 weeks /3 weeks. GM1 / placebo was administered 1 day before administration (D0), on the day of administration (D1) and on the day after administration (D2), and albumin-paclitaxel-based chemotherapy was administered from day 1, with a total of 4/6 cycles of administration. | Drug | A, B, C |
Primary outcome
Grade ≥2 neurotoxicity （CTCAE）
Time frame: C4D3
The difference between the FACT/GOG-Ntx score and the baseline score
Time frame: C4D3
4 secondary outcomes
The incidence of peripheral neurotoxicity during cycles 1 to 6 and follow-up
Time frame: 12 month
Change in FACT/GOG-Ntx scores from baseline during 1-6 cycles and follow-up
Time frame: 12 month
Change in CIPN20 score from baseline after 1-6 cycles and follow-up
Time frame: 12 month
incidence of adverse events
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Monosialotetrahexose ganglioside sodium injection in people with To Evaluate the Effectiveness of GM1 in the Prevention of Albumin-paclitaxel Therapy Induced Peripheral Neuropathy in Breast Cancer Patients, run by Qilu Pharmaceutical Co., Ltd..
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 11 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 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Grade ≥2 neurotoxicity （CTCAE） (time frame: C4D3). The study lists 2 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 6 Apr 2023.