Trial of Ruxolitinib and Erlotinib in Patients With EGFR-mutant Lung Adenocarcinoma With Acquired Resistance to Erlotinib
|ClinicalTrials.gov Identifier: NCT02155465|
Recruitment Status : Completed
First Posted : June 4, 2014
Last Update Posted : October 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Ruxolitinib Drug: Erlotinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Trial of Ruxolitinib and Erlotinib in Patients With EGFR-mutant Lung Adenocarcinoma With Acquired Resistance to Erlotinib|
|Actual Study Start Date :||June 2014|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
U.S. FDA Resources
Experimental: Ruxolitinib and Erlotinib
Phase I The study will follow a standard 3+3 dose escalation trial design. Three to six patients will need to be enrolled at each dose level and assessed for DLT for 1 full cycle (21 days) before a dose escalation decision is made.
Phase II Once the MTD has been determined, patients will be enrolled in the phase 2 portion of the single-arm, two-stage, open-label study to determine efficacy of erlotinib and ruxolitinib. Patients will receive erlotinib and ruxolitinib at the MTD established in the phase I portion. The patient take their previous dose of erlotinib if it is less than 150mg daily.
Ruxolitinib 10mg PO BID
Ruxolitinib 15mg PO BID
Ruxolitinib 20mg PO BID
Erlotinib 150mg PO QD
- maximally tolerated dose (MTD) (Phase I) [ Time Frame: 1 year ]All patients will receive erlotinib at 150mg orally daily along with doses of ruxolitinib orally twice daily. Patients in dose level 1 will receive erlotinib 150mg orally daily and ruxolitinib 10mg orally twice daily. In dose level 2, patients will receive erlotinib 150mg orally daily and ruxolitinib 15mg orally twice daily. In dose level 3, patients will receive erlotinib 150mg orally daily and ruxolitinib 20mg orally twice daily.
- Assess overall response rate (Phase I) [ Time Frame: 1 year ]Tumor response will be assessed using RECIST 1.1.
- toxicity profile (Phase I) [ Time Frame: 2 years ]Toxicity grading will be performed in accordance with NCI CTCAE, version 4.0.
- survival (Phase II) [ Time Frame: 2 years ]Overall survival and time to progression will be estimated using the Kaplan-Meier method, with the follow-up starting at the initiation of therapy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02155465
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering West Harrison|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering at Mercy Medical Center|
|Rockville Centre, New York, United States|
|Memoral Sloan Kettering Cancer Center at Phelps|
|Sleepy Hollow, New York, United States, 10591|
|Principal Investigator:||Helena Yu, MD||Memorial Sloan Kettering Cancer Center|