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Ruxolitinib in Combination With Pemetrexed/Cisplatin in Non Small Cell Lung Cancer

NCT02119650 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2018-02-13

Study results available
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Summary

The purpose of this study was to determine if ruxolitinib, in combination with Pemetrexed/Cisplatin and Pemetrexed Maintenance, is safe and effective in the treatment of nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent.

Conditions

  • NSCLC (Non-small Cell Lung Carcinoma)

Interventions

DRUG

Ruxolitinib

5 mg tablets to be administered by mouth at dose selected from safety run-in phase (Ruxolitinib 15 mg twice daily (BID))

DRUG

Placebo

5 mg matching placebo tablets to be administered by mouth

DRUG

Pemetrexed

500 mg/m\^2 administered as an intravenous infusion over 10 minutes

DRUG

Cisplatin

75 mg/m\^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion

Sponsors & Collaborators

Principal Investigators

  • Gerard T Kennealey, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-11
Primary Completion
2016-02-11
Completion
2016-06-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02119650 on ClinicalTrials.gov