MedTrace Logo

iPSC-based Drug Repurposing for ALS Medicine (iDReAM) Study

NCT04744532 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2023-03-08

No results posted yet for this study

Summary

This study consists of a phase 1 part and a phase 2 part.

Phase 1 part:

This is a phase 1, open-label, multicenter, dose escalation study to evaluate the safety and tolerability of bosutinib to determine the maximum tolerated dose(MTD) and a recommended phase 2 dose (RP2D) of bosutinib for treatment of ALS patients. Also, efficacy will be evaluated exploratory.

Phase 2 part:

This is an open label, multicenter, phase 2 part whose purpose is to evaluate the efficacy exploratorily and the long-term (for 24 weeks) safety of bosutinib for the treatment of ALS patients.

Conditions

Interventions

DRUG

Bosutinib (Phase 1 part)

Subjects will receive 100 mg, 200mg, 300mg or 400 mg of bosutinib once daily, orally.

DRUG

Bosutinib (Phase 2 part)

Subjects will receive 200mg/day or 300mg/day of bosutinib once daily, orally.

Sponsors & Collaborators

  • Tokushima University

    collaborator UNKNOWN

  • Kitasato University

    collaborator OTHER

  • Tottori University

    collaborator UNKNOWN

  • Nara Medical University

    collaborator OTHER

  • Toho University

    collaborator OTHER

  • Hiroshima University

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Kyoto University

    lead OTHER

Principal Investigators

  • Haruhisa Inoue · Kyoto University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT04744532 on ClinicalTrials.gov