This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been terminated.
(The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation.)
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02119650
First received: April 17, 2014
Last updated: June 9, 2017
Last verified: June 2017
  Purpose
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.

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: Participant, 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:
  • Overall Survival (OS) [ Time Frame: Randomization until death due to any cause; up to 16 months or data cutoff 11FEB2016. ]
    Overall survival is defined as the time from randomization to death due to any cause. Participants without death observed at the time of the analysis will be censored at last date known to be alive. The median overall survival time was estimated using the Kaplan-Meier method. Overall survival was compared between treatment groups using log-rank test.


Secondary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: Randomization to disease progression, or death due to any cause if sooner; up to 16 months or to the data cutoff 11FEB2016. ]
    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. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.

  • Objective Response Rate (ORR) [ Time Frame: Baseline through end of study; up to 16 months or to the data cutoff 11FEB2016. ]
    Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.

  • Duration of Response [ Time Frame: From the start of response to the end of response; up to 16 months or to the data cutoff 11FEB2016. ]
    For objective responders, the duration of response is defined as the difference of the end of response and the start of response for subjects. The start of a response will be the first visit where the subject achieves PR or better based on RECIST v1.1 criteria. The end of response will be the first visit after PD based on RECIST v1.1 criteria.

  • Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline through approximately 30 days post treatment discontinuation; up to 16 months or to the data cutoff 11FEB2016. ]
    A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).


Enrollment: 76
Actual Study Start Date: February 2014
Study Completion Date: February 2017
Primary Completion Date: February 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 15 mg twice daily (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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 activating driver mutations for which there is available therapy (eg, tumor without mutations in epidermal growth factor receptor or anaplastic lymphoma).
  • An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:

    • Criteria:

      • C-reactive protein >10 mg/L AND albumin ≥35 g/L; Score = 1
      • C-reactive protein >10 mg L AND albumin <35 g/L; Score = 2
  • 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

  Show 30 Study Locations
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Gerard T Kennealey, MD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02119650     History of Changes
Other Study ID Numbers: INCB 18424-266
Study First Received: April 17, 2014
Results First Received: February 10, 2017
Last Updated: June 9, 2017

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
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 19, 2017