A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Non Small Cell Lung Cancer, Small-cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT04022876
- Run by
- Aileron Therapeutics, Inc.
- People needed
- 35
- Starts
- 2019-09-03
- Expected to finish
- 2022-08-30
- Last updated by the study team
- 2022-10-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arizona Cancer Center — Kingman, Arizona, United States
- Mount Sinai Cancer Research Program — Miami, Florida, United States
- Oncology & Hematology Associates of West Broward — Tamarac, Florida, United States
- H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
- Regional Medical Oncolgy Center — Wilson, North Carolina, United States
- Gabrail Cancer Institute — Canton, Ohio, United States
- OSHU CHO Northwest — Portland, Oregon, United States
- Gettysburg Cancer Center — Gettysburg, Pennsylvania, United States
- University Clinical Center of the Republic of Srpska, Lung Clinic — Banja Luka, Bosnia and Herzegovina
- Clinical Center University of Sarajevo, Oncology Clinic — Sarajevo, Bosnia and Herzegovina
- Charité Comprehensive Cancer Center Benjamin Franklin Hamato, Onkologische — Berlin, Germany
- Universitaetsklinikum Heidelberg Thoraxklinik Heidelberg — Heidelberg, Germany
- LMU Klinikum der Universitaet Muenchen, Respiratory Medicine and Thoracic Oncology, Campus Innenstandt — München, Germany
- München Klinik Neuperlach, Klinik für Hamatologie und Onkologie, Studienburo Neuperlach/Harlaching — München, Germany
- Istituto Romagnolo per lo Studio dei Tumori, Dino Amadori — Meldola, Italy
- Azienda Ospedaliero, Universitaria di Modena, Policlinico di Modena — Modena, Italy
- Istituto Nazionale Tumori di Napoli, IRCCS, Fondazione, G. Pascale — Naples, Italy
- Università degli Studi di Pavia, IRCCS, Fondazione, Policlinico San Matteo — Pavia, Italy
- Azienda Unità Sanitaria Locale della Romagna, Ospedale Santa Maria delle Croci — Ravenna, Italy
- Azienda Ospedaliera Universitaria Integrata Verona — Verona, Italy
- Szpital Kliniczny Przemienienia Panskiego — Poznan, Poland
- CHC Bezanijska Kosa — Belgrade, Serbia
- University Clinical Centre of Serbia, Pulmonology Clinic — Belgrade, Serbia
- Clinical Centre Nis, Clinic for Pulmonary Diseases — Niš, Serbia
- Institute for Pulmonary Diseases of Vojvodina — Novi Sad, Serbia
Full record on ClinicalTrials.gov
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