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A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL

NCT02081378 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2024-03-18

No results posted yet for this study

Summary

The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in Chronic myeloid leukemia (CML) and Philadelphia chromosome positive Acute lymphoblastic leukemia (Ph+ ALL) patients who are relapsed or refractory to or are intolerant of Tyrosine kinase inhibitors (TKIs), and of ABL001+Nilotinib, ABL001+Imatinib and ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.

Conditions

  • Chronic Myelogenous Leukemia
  • Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Interventions

DRUG

Asciminib (ABL001)

Asciminib was be administered orally in a dose escalation schedule.

DRUG

Nilotinib

Asciminib and Nilotinib was administered orally in CML patients

DRUG

Imatinib

Asciminib and imatinib was administered orally in CML patients

DRUG

Dasatinib

Asciminib and dasatinib was administered orally in CML patients

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-24
Primary Completion
2021-06-03
Completion
2023-03-14
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Singapore
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
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 NCT02081378 on ClinicalTrials.gov