Phase I Study of the Combination of Afatinib and Ruxolitinib in Patients With Treatment-refractory Non-Small Cell Lung Cancer (NSCLC)

Yonsei University0 sites30 target enrollmentMay 7, 2015

ConditionsNSCLC

InterventionsAfatinib plus Ruxolitinib combination therapy

DrugsAfatinib plus Ruxolitinib combination therapy

Overview

Phase: Phase 1
Intervention: Afatinib plus Ruxolitinib combination therapy
Conditions: NSCLC
Sponsor: Yonsei University
Enrollment: 30
Primary Endpoint: To set a recommended phase II dose (RP2D)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This phase Ib study will investigate dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of afatinib and ruxolitinib combination therapy, based on the preclinical data that inhibition of IL-6R/JAK1 signal transmission pathway will increase sensitivity to afatinib.

Registry

clinicaltrials.gov

Start Date

May 7, 2015

End Date

November 9, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Yonsei University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Stage 4 NSCLC patients
•disease progression after platinum doublet (all), EGFR TKI (if EGFR mutant), and crizotinib (if ALK positive)
•Men and women aged 20 years or older
•Recovery from previous drug-related toxicity: CTCAE 4.03 ≤ Grade 1
•ECOG 0 or 1
•able to orally take and retain drug
•have a measurable or unmeasurable lesion under RECIST 1.1 Criteria
•have proper hematological, renal, and hepatic functions
•intention to use an acceptable contraception
•able to read and understand the informed consent form

Exclusion Criteria

•previous chemotherapy, radiation therapy, immunotherapy, or other anticancer therapy within 14 days
•Clinically significant gastrointestinal disorder or malabsorption syndrome
•Acute digestive disorder
•major organ failure
•Significant cardiac disorders
•major operation of a main organ in 4 weeks
•Untreated symptomatic brain metastasis
•pregnant or nursing
•previously diagnosed Interstitial lung disease(ILD)
•previously treated with irreversible pan-HER inhibitor including Afatinib or Ruxolitinib