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Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel

StatusActive, Not Recruiting
PhasePhase 2
Started2023-11-02
View on ClinicalTrials.gov ↗

Amendment history

2026-09-17
notable
Trial status changed: Suspended → Active, Not Recruiting
Final enrollment: 7 participants — 7% of the 98 planned
2026-08-04
minor
3 amendments v14-v16
3 re-verifications since 2026-04-06, no change to tracked fields
2026-02-03
notable
Recruiting→Suspended Study Status, Contacts/Locations v13
Trial statusRecruiting→Suspended
Reason stoppednot stated→Interim analysis
Study sitesdetails revised at 33 of 33 sites
2025-08-04
minor
Study Status v12
Primary completion date2026-01-15→2028-03-15
Completion date2030-05-31→2032-03-15
2025-06-24
minor
Study Status, Contacts/Locations v11
Study sitescontacts updated at 2 of 33 sites
Show 10 earlier versions
2025-03-28
minor
Study Identification, Study Status, Oversight, Conditions, Contacts/Locations v10
Study sites31→33
Study titlerevised
Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment withWith Paclitaxel (Phase II)
2025-01-15
minor
Study Identification, Study Status, Oversight, Conditions, Contacts/Locations v9
Study sitescontacts updated at 30 of 31 sites
Study titlerevised
Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment Withwith Paclitaxel (Phase II)
2024-12-24
minor
Study Status, Contacts/Locations v8
Primary completion date2030-05-31→2026-01-15
Study sites28→31
2024-10-24
minor
Study Status, Contacts/Locations v7
Study sites27→28
2024-08-01
minor
Study Status, Contacts/Locations v6
Study sites22→27
2024-05-22
minor
Study Status, Contacts/Locations v5
Study sites19→22
2024-04-08
minor
Study Status, Contacts/Locations v4
Start date2023-05-31→2023-11-02
Study sites16→19
2024-02-19
minor
Study Status, Contacts/Locations v3
Study sites5→16
2023-08-02
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sites0→5
2023-05-11
minor
Study Status v1
Start date2023-03-31→2023-05-31
2023-02-21
minor
Original filing
This early phase/phase II trial tests the safety, side effects, and best dose of monosialotetrahexosylganglioside (GM1) and whether it works in reducing or preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) who are receiving treatment with paclitaxel. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Exposure to chemotherapy drugs like paclitaxel may cause a side effect called CIPN, which is a condition of weakness, numbness, and pain from nerve damage (usually in the hands and feet). GM1 is a part of the body's natural system that insulates nerves and helps to protect nerves from damage. Giving GM1 may help reduce or prevent CIPN in breast cancer patients receiving treatment with paclitaxel.
Trial Details
NCT Number NCT05751668
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Anatomic Stage IV Breast Cancer AJCC v8, Chemotherapy-Induced Peripheral Neuropathy, Metastatic Breast Carcinoma
Enrollment 7 participants
Start Date 2023-11-02
Primary Completion 2028-03-15 (estimated)
Study Completion 2032-03-15 (estimated)
Updated on ClinicalTrials.gov 2026-10-01