MedTrace Logo

An Open-Label, Phase I/II Study of Nilotinib (Tasigna) and MEK-162 (ARRY-162) Used in Combination for Patients With Refractory or Advanced Chronic Myeloid Leukemia and Philadelphia Positive Acute Leukemia (Protocol CAMN107AUS41T)

NCT02225574 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-02-12

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerated dose of the combination of nilotinib and MEK-162 that can be given to patients with CML or acute leukemia. Researchers also want to learn if the drug combination can help to control the disease. The safety of the drug combination will also be studied.

Conditions

Interventions

DRUG

MEK-162

Phase 1: Advanced CML + Philadelphia positive Acute Leukemia-Group 1 Starting Dose of MEK-162: 30 mg by mouth twice a day on starting on Day 1 of a 28 day cycle. Phase 2 Advanced CML + Philadelphia positive Acute Leukemia-Group 1 Starting dose of MEK-162: MTD from Phase 1 to be taken by mouth twice a day starting on on Day 1 of a 28 day cycle. Phase 1 Chronic Phase CML - Group 2 Starting dose of MEK-162: 30 mg by mouth twice a day of a 28 day cycle. Phase 2 Chronic Phase CML - Group 2 Starting Dose of MEK-162: MTD from Phase 1 by mouth twice a day starting on Day 8 of a 28 day cycle.

DRUG

Nilotinib

Phase 1 Advanced CML + Philadelphia positive Acute Leukemia-Group 1 Starting Dose of Nilotinib: 400 mg by mouth twice a day of a 28 day cycle. Phase 2 Advanced CML + Philadelphia positive Acute Leukemia-Group 1 Starting dose of Nilotinib: MTD from Phase 1 to be taken by mouth twice a day starting on Day 2 of a 28 day cycle. Phase 1 Chronic Phase CML - Group 2 Starting dose of Nilotinib: 400 mg by mouth twice a day of a 28 day cycle. Phase 2 Chronic Phase CML - Group 2 Starting Dose of Nilotinib: MTD from Phase 1 by mouth twice a day starting on Day 1 of a 28 day cycle.

BEHAVIORAL

Questionnaires

Questionnaires completed and the end of cycle 1, 2, 3, 6, 9, and 12.

Sponsors & Collaborators

  • Array BioPharma

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Naval Daver, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-11
Primary Completion
2017-02-02
Completion
2017-02-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02225574 on ClinicalTrials.gov