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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02119650
First received: April 17, 2014
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

The purpose of this study is 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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Ruxolitinib
Drug: Placebo
Drug: Pemetrexed
Drug: Cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Part 1: Determination of the dose of ruxolitinib that is safe and tolerable in combination with pemetrexed/cisplatin as measured by the number of dose-limiting toxicities (DLTs) observed in the evaluation cohort. [ Time Frame: Baseline through Day 21 ] [ Designated as safety issue: Yes ]
    Subjects will receive infusions of pemetrexed and cisplatin on Day1 of Cycle 1, and begin dosing with ruxolitinib, twice daily (BID). The safety and tolerability of the regimen will be assessed during the first 21 days of therapy.

  • Part 2: Overall Survival (OS) [ Time Frame: Randomization until death due to any cause. Approximately 24 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Randomization to disease progression, or death due to any cause if sooner. Approximately 24 months. ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner.

  • Objective Response Rate [ Time Frame: Baseline through end of study. Approximately 24 months. ] [ Designated as safety issue: No ]
    Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment

  • Duration of Response [ Time Frame: Baseline through end of study. Approximately 24 months. ] [ Designated as safety issue: No ]
    Duration of response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment

  • Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments. [ Time Frame: Baseline through approximately 30 days post treatment discontinuation. Assessed after approximately 24 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 156
Study Start Date: March 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ruxolitinib plus Pemetrexed/Cisplatin Drug: Ruxolitinib

5 mg tablets to be administered by mouth at dose selected from safety run-in phase

(Ruxolitinib 15mg BID or Ruxolitinib 10mg BID)

Other Names:
  • Jakafi ®
  • Jakavi ®
Drug: Pemetrexed
500 mg/m^2 administered as an intravenous infusion over 10 minutes
Other Name: Alimta®
Drug: Cisplatin
75 mg/m^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion
Active Comparator: Placebo plus Pemetrexed/Cisplatin 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
Other Name: Alimta®
Drug: Cisplatin
75 mg/m^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion

Detailed Description:

The study consists of an open-label, safety run-in (consisting of 1 to 4 cohorts of 9 subjects each), to confirm the safety of ruxolitinib in combination with pemetrexed/cisplatin in subjects with nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent. Subjects in the safety run-in will receive open-label ruxolitinib and pemetrexed and cisplatin.

In the second part of the study, subjects will be enrolled and randomized to receive pemetrexed and cisplatin (open-label) and either ruxolitinib or placebo in a blinded manner. The dose of ruxolitinib administered will be determined from the data produced in the safety run-in phase.

Treatment will consist of repeating 21-day cycles. Subjects will receive infusions of pemetrexed and cisplatin on Day 1 of each cycle and ruxolitinib/placebo will be self-administered during the entire cycle. Maintenance therapy with ruxolitinib or placebo in combination with pemetrexed, based on the original treatment assignment, will be allowed for subjects eligible for maintenance therapy.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of nonsquamous NSCLC that is Stage IIIB Stage IV, or recurrent after prior definitive intervention (radiation, surgery, or chemoradiation therapy, with or without adjuvant or neoadjuvant chemotherapy).
  • Radiographically measurable or evaluable disease.
  • Life expectancy of at least 12 weeks.
  • Tumor without a driver mutation (eg, epidermal growth factor receptor mutation positive or anaplastic lymphoma kinase fusion oncogene positive).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit

Exclusion Criteria:

  • Squamous or mixed histology (eg, adenosquamous) NSCLC
  • Previous systemic therapy for advanced or metastatic disease.
  • Known active central nervous system (CNS) metastases.
  • Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval.
  • Current uncontrolled cardiac disease such as angina or myocardial infarction, congestive heart failure including New York Heart Association functional classification of 3, or arrhythmia requiring treatment.
  • Uncontrolled concomitant medical conditions, including, but not limited to, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric diseases.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02119650

Contacts
Contact: Incyte Corporation Call Center 1-855-463-3463

Locations
United States, Arkansas
Recruiting
Fayetteville, Arkansas, United States
United States, Connecticut
Recruiting
Norwich, Connecticut, United States
Recruiting
Southington, Connecticut, United States
United States, Illinois
Recruiting
Joilet, Illinois, United States
United States, Indiana
Recruiting
Lafayette, Indiana, United States
United States, Michigan
Recruiting
Detroit, Michigan, United States
United States, Missouri
Recruiting
Saint Louis, Missouri, United States
United States, Nevada
Recruiting
Reno, Nevada, United States
United States, New York
Recruiting
Mount Kisco, New York, United States
United States, North Carolina
Recruiting
Winston-Salem, North Carolina, United States
United States, Ohio
Recruiting
Canton, Ohio, United States
United States, Utah
Recruiting
Ogden, Utah, United States
United States, Virginia
Recruiting
Leesburg, Virginia, United States
United States, Washington
Recruiting
Kennewick, Washington, United States
Recruiting
Seattle, Washington, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Gerard T Kennealey, MD Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02119650     History of Changes
Other Study ID Numbers: INCB 18424-266
Study First Received: April 17, 2014
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
Non small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pemetrexed
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 30, 2014