NCT02119650

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

A Randomized, Double-Blind Phase 2 Study of Ruxolitinib or Placebo in Combination With Pemetrexed/Cisplatin and Pemetrexed Maintenance for Initial Treatment of Subjects With Nonsquamous Non-Small Cell Lung Cancer That Is Stage IIIB, Stage IV, or Recurrent

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study consisted of an open-label, safety run-in (consisting of 1 to 4 cohorts of 9 participants each), to confirm the safety of ruxolitinib in combination with pemetrexed/cisplatin in participants with nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent. Participants in the safety run-in received open-label ruxolitinib and pemetrexed and cisplatin. In the second part of the study, participants enrolled and randomized and received pemetrexed and cisplatin (open-label) and either ruxolitinib or placebo in a blinded manner. The dose of ruxolitinib administered was determined from the data produced in the safety run-in phase. Treatment consisted of repeating 21-day cycles. Participants received infusions of pemetrexed and cisplatin on Day 1 of each cycle and ruxolitinib/placebo was self-administered during the entire cycle. Maintenance therapy with ruxolitinib or placebo in combination with pemetrexed, based on the original treatment assignment, was allowed for participants eligible for maintenance therapy.

Conditions

• NSCLC (Non-small Cell Lung Carcinoma)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-02-11
• Primary completion: 2016-02-11
• Completion: 2016-06-21
• First posted: 2014-04-22
• Last updated: 2018-02-13
• Results posted: 2017-06-14

Locations

30 sites across 1 country: United States