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

Sponsor
Yonsei University
Study ID
NCT02145637
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 7, 2015
Status verified
Mar 2018
Primary completion
Nov 9, 2017
Completion
Nov 9, 2017

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Afatinib plus Ruxolitinib combination (single arm)

Primary Outcome Measure

To set a recommended phase II dose (RP2D) [ Time Frame: 36 days ]

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