A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)

NCT04022876 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: ALRN-6924-1-03
• Study Type: interventional
• Target: 35
• Locations: 7 countries
• Sites: 28

Brief 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.

Conditions

Non Small Cell Lung Cancer; Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Phase 1b Part 2 NSCLC

  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.

  Approximately 6 months

• Phase 1b Part 1 SCLC

  Proportion of patients with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3/4 treatment emergent adverse events (TEAEs)

  Approximately 19 months

Study Arms (3)

Part 2 NSCLC: ALRN-6924+Carboplatin+Pemetrexed

EXPERIMENTAL

Drug: ALRN-6924; Drug: Carboplatin; Drug: Pemetrexed

Part 2 NSCLC: Placebo+Carboplatin+Pemetrexed

EXPERIMENTAL

Drug: Carboplatin; Drug: Pemetrexed; Drug: Placebo

Part 1 SCLC: ALRN-6924+Topotecan

EXPERIMENTAL

Drug: ALRN-6924; Drug: Topotecan

Interventions

Carboplatin DRUG

Carboplatin administered IV on Day 1 of every 21-day cycle.

Part 2 NSCLC: ALRN-6924+Carboplatin+Pemetrexed; Part 2 NSCLC: Placebo+Carboplatin+Pemetrexed

Pemetrexed DRUG

Pemetrexed administered IV on Day 1 of every 21-day cycle.

Part 2 NSCLC: ALRN-6924+Carboplatin+Pemetrexed; Part 2 NSCLC: Placebo+Carboplatin+Pemetrexed

Placebo DRUG

Placebo administered IV on Days 0-2 prior to carboplatin and pemetrexed administered IV on Day 1 of every 21-day cycle.

Part 2 NSCLC: Placebo+Carboplatin+Pemetrexed

ALRN-6924 DRUG

ALRN-6924 administered IV on Days 0-2 prior to carboplatin and pemetrexed administered IV on Day 1 of every 21-day cycle.

Part 2 NSCLC: ALRN-6924+Carboplatin+Pemetrexed

Topotecan DRUG

Topotecan administered IV on Days 1-5 of every 21-day cycle.

Part 1 SCLC: ALRN-6924+Topotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathological confirmation of Stage IV NSCLC of adenocarcinoma histology. Cytological diagnosis of NSCLC is acceptable if sufficient tumor tissue is available for p53 mutation analysis. FDA approved liquid biopsies are also acceptable.
• Presence of one or more p53 mutations.
• Measurable disease using RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
• Adequate hematological status.
• Adequate hepatic and renal function.

You may not qualify if:

• Advanced NSCLC tumors with EGFR mutations or ALK re-arrangement or other actionable genetic aberrations for which an approved targeted treatment is available. Patients who received prior treatment with EGFR or ALK inhibitors or other systemic drugs or immunotherapy for NSCLC are not eligible.
• Patients who are candidates for anti-PD-1 monotherapy in 1st line advanced NSCLC (e.g. tumors with high PD-L1 expression).
• Presence of active central nervous system metastases and/or carcinomatous meningitis.
• Significant weight loss (≥15% body weight) within the 4 weeks prior to enrollment.
• Histopathological confirmation of ED SCLC that has recurred or been refractory to one line of treatment with standard platinum-based chemotherapy or immuno-chemotherapy. Patients who received immunotherapy after platinum-based chemotherapy are eligible.
• Presence of one or more p53 mutations.
• Measurable disease using RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
• Adequate hematological status.
• Adequate hepatic and renal function.
• More than one line of prior chemotherapy for ED SCLC (prior immunotherapy is permitted, concurrent with or subsequent to first line chemotherapy).
• Presence of active central nervous system metastases and/or carcinomatous meningitis.
• Significant weight loss (≥15% body weight) within the 4 weeks prior to enrollment.

Sponsors & Collaborators

• Aileron Therapeutics, Inc.: lead

Study Sites (28)

Arizona Cancer Center

Kingman, Arizona, 86409, United States

Location

Mount Sinai Cancer Research Program

Miami, Florida, 33140, United States

Location

Oncology & Hematology Associates of West Broward

Tamarac, Florida, 33321, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Regional Medical Oncolgy Center

Wilson, North Carolina, 27893, United States

Location

Gabrail Cancer Institute

Canton, Ohio, 44718, United States

Location

OSHU CHO Northwest

Portland, Oregon, 97210, United States

Location

Gettysburg Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

University Clinical Center of the Republic of Srpska, Lung Clinic

Banja Luka, Bosnia and Herzegovina

Location

Clinical Center University of Sarajevo, Oncology Clinic

Sarajevo, Bosnia and Herzegovina

Location

Charité Comprehensive Cancer Center Benjamin Franklin Hamato, Onkologische

Berlin, Germany

Location

Universitaetsklinikum Heidelberg Thoraxklinik Heidelberg

Heidelberg, Germany

Location

LMU Klinikum der Universitaet Muenchen, Respiratory Medicine and Thoracic Oncology, Campus Innenstandt

München, Germany

Location

München Klinik Neuperlach, Klinik für Hamatologie und Onkologie, Studienburo Neuperlach/Harlaching

München, Germany

Location

Istituto Romagnolo per lo Studio dei Tumori, Dino Amadori

Meldola, Italy

Location

Azienda Ospedaliero, Universitaria di Modena, Policlinico di Modena

Modena, Italy

Location

Istituto Nazionale Tumori di Napoli, IRCCS, Fondazione, G. Pascale

Napoli, Italy

Location

Università degli Studi di Pavia, IRCCS, Fondazione, Policlinico San Matteo

Pavia, Italy

Location

Azienda Unità Sanitaria Locale della Romagna, Ospedale Santa Maria delle Croci

Ravenna, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Location

Szpital Kliniczny Przemienienia Panskiego

Poznan, Poland

Location

CHC Bezanijska Kosa

Belgrade, Serbia

Location

University Clinical Centre of Serbia, Pulmonology Clinic

Belgrade, Serbia

Location

Clinical Centre Nis, Clinic for Pulmonary Diseases

Niš, Serbia

Location

Institute for Pulmonary Diseases of Vojvodina

Novi Sad, Serbia

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

MD Anderson Cancer Center

Madrid, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Carboplatin; Pemetrexed; Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Camptothecin; Alkaloids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 17, 2019
• Study Start: September 3, 2019
• Primary Completion: July 30, 2022
• Study Completion: August 30, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

US (8); DE (4); BO (2); IT (6); PL (1); ES (3); SE (4)