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

NCT04022876 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-10-10

No results posted yet for this 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.

Conditions

  • Non Small Cell Lung Cancer
  • Small-cell Lung Cancer

Interventions

DRUG

ALRN-6924

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

DRUG

Carboplatin

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

DRUG

Pemetrexed

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

DRUG

Placebo

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

DRUG

ALRN-6924

ALRN-6924 administered IV on Days 0-4 prior to topotecan administered IV on Days 1-5 of every 21-day cycle.

DRUG

Topotecan

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

Sponsors & Collaborators

  • Aileron Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-03
Primary Completion
2022-07-30
Completion
2022-08-30
FDA Drug
Yes

Countries

  • United States
  • Bosnia and Herzegovina
  • Germany
  • Italy
  • Poland
  • Serbia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04022876 on ClinicalTrials.gov