Trial of Ruxolitinib and Erlotinib in Patients With EGFR-mutant Lung Adenocarcinoma With Acquired Resistance to Erlotinib

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02155465
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ruxolitinib — DRUG
    Ruxolitinib 10mg PO BID Ruxolitinib 15mg PO BID Ruxolitinib 20mg PO BID
  • Erlotinib — DRUG
    Erlotinib 150mg PO QD

Study Details

This is a phase 2 study. The goal of this study is to find out what effects, good and/or bad, taking erlotinib and ruxolitinib has on the patients and on lung cancer. Erlotinib and ruxolitinib are FDA approved for other indications, but the use of erlotinib and ruxolitinib together has not been studied before and is not FDA-approved.

Key Dates

Start date
Jun 30, 2014
Status verified
Oct 2017
Primary completion
Oct 31, 2017
Completion
Oct 31, 2017

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Maximally Tolerated Dose (MTD) (Phase I) [ Time Frame: 1 year ]

Locations (6)

FacilityCityStateZIPSite coordinators
Memoral Sloan Kettering Cancer CenterBasking RidgeNew Jersey--
Memorial Sloan Kettering Cancer Center @ SuffolkCommackNew York11725-
Memorial Sloan Kettering West HarrisonHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering at Mercy Medical CenterRockville CentreNew York--
Memoral Sloan Kettering Cancer Center at PhelpsSleepy HollowNew York10591-

Find similar trials in Basking Ridge, NJ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Memoral Sloan Kettering Cancer Center· Basking Ridge, NJMemorial Sloan Kettering Cancer Center @ Suffolk· Commack, NYMemorial Sloan Kettering West Harrison· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NYMemorial Sloan Kettering at Mercy Medical Center· Rockville Centre, NYMemoral Sloan Kettering Cancer Center at Phelps· Sleepy Hollow, NY

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