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Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers

NCT03868423 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-02-18

No results posted yet for this study

Summary

This phase II trial studies how well brigatinib works in treating patients with ALK and ROS1 gene alterations and solid cancers that have spread to nearby tissue and lymph nodes or other places in the body. Brigatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

  • Advanced Malignant Neoplasm
  • ALK Fusion Protein Expression
  • ALK Gene Amplification
  • ALK Gene Mutation
  • Locally Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Neoplasm in the Brain
  • Metastatic Malignant Neoplasm in the Central Nervous System
  • Metastatic Malignant Solid Neoplasm
  • ROS1 Fusion Positive
  • ROS1 Gene Amplification
  • ROS1 Gene Mutation

Interventions

DRUG

Brigatinib

90 mg orally QD for 7 days followed by 180 mg orally QD continuously thereafter. One cycle of therapy will consist of 28 days of treatment.

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sameek Roychowdhury

    lead OTHER

Principal Investigators

  • Sameek Roychowdhury, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2020-11-20
Completion
2021-12-30
FDA Drug
Yes

Countries

  • United States

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 NCT03868423 on ClinicalTrials.gov