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NCT04022876 · ClinicalTrials.gov registry record · Phase 1
A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)
A Phase 1 study, sponsored by Aileron Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT04022876: Clinical Trial Phase 1 study, sponsored by Aileron Therapeutics.
NCT04022876 is a Phase 1 study that was terminated before completion, run by Aileron Therapeutics. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04022876, a Phase 1 study, was terminated before completion, sponsored by Aileron Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a Phase 1b, multicenter, 2-part study of ALRN-6924 for the prevention of chemotherapy-induced side effects. Part 1 SCLC is an open-label, multicenter study of ALRN-6924 for the prevention of chemotherapy-induced side effects in patients with p53-mutated ED SCLC undergoing 2nd-line treatment with topotecan. (Part 1 has completed enrollment). Part 2 NSCLC is a randomized, double-blind, placebo-controlled, multicenter study of ALRN-6924 for the prevention of chemotherapy-induced side effects in patients with p53-mutated advanced NSCLC of adenocarcinoma histology receiving 1st-line treatment with carboplatin plus pemetrexed with or without immunotherapy.
Primary Outcome
Proportion of completed treatment cycles that are free of Grade ≥ 3 hematological toxicities (including neutropenia, anemia, thrombocytopenia and febrile neutropenia), and free of chemotherapy dose reductions, and free of use of growth factors and transfusions.
Interventions
- DRUG Carboplatin
- DRUG Placebo
- DRUG Pemetrexed
- DRUG ALRN-6924
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2019-09-03 |
| Est. Completion | 2022-08-30 |
| Phase | Phase 1 |
Why NCT04022876 stopped before completion
NCT04022876 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT04022876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04022876 about?
NCT04022876 is a clinical study titled "A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)". This is a Phase 1b, multicenter, 2-part study of ALRN-6924 for the prevention of chemotherapy-induced side effects. Part 1 SCLC is an open-label, multicenter study of ALRN-6924 for the prevention of chemotherapy-induced side effects in patients with p53-mutated ED SCLC undergoing 2nd-line treatment...
What is the current status of trial NCT04022876?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2019-09-03. Estimated completion is 2022-08-30.
What interventions are being tested in trial NCT04022876?
The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Pemetrexed (DRUG), ALRN-6924 (DRUG).
Who is sponsoring clinical trial NCT04022876?
This trial is sponsored by Aileron Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04022876's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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