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NCT05622058 · ClinicalTrials.gov registry record · Phase 1
A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer
A Phase 1 study, sponsored by Aileron Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT05622058 is a Phase 1 study that was terminated before completion, run by Aileron Therapeutics. The registered enrollment target is 6 participants.
The verdict
NCT05622058, a Phase 1 study, was terminated before completion, sponsored by Aileron Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with doxorubicin, docetaxel, and cyclophosphamide (TAC). Chemotherapy affects cells that are dividing, whether they are tumor cells or healthy cells (including, bone marrow cells, hair follicle cells, and epithelial cells lining the gastrointestinal tract). ALRN-6924 is designed to stop cell division in healthy cells but not in tumor cells because they have a mutation of the TP53 gene. When this happens, tumor cells will still be destroyed by the chemotherapy but healthy cells that are not dividing may be spared from chemotherapy damage and the patient should have less side effects.
Interventions
- DRUG ALRN-6924
- DRUG TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2023-01-09 |
| Est. Completion | 2023-02-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05622058
The ClinicalTrials.gov registry entry for NCT05622058 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aileron Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ALRN-6924 is the first listed.
NCT05622058 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05622058 about?
NCT05622058 is a clinical study titled "A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer". This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with doxorubicin, docetaxel, and cyclophosphamide (TAC). Chemotherapy affects ce...
What is the current status of trial NCT05622058?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2023-01-09. Estimated completion is 2023-02-22.
What interventions are being tested in trial NCT05622058?
The interventions under investigation include: ALRN-6924 (DRUG), TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2) (DRUG).
Who is sponsoring clinical trial NCT05622058?
This trial is sponsored by Aileron Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
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