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

Information source: Incyte Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma, Non-Small-Cell Lung

Intervention: Ruxolitinib (Drug); Placebo (Drug); Pemetrexed (Drug); Cisplatin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Incyte Corporation

Official(s) and/or principal investigator(s):
Gerard T Kennealey, MD, Study Director, Affiliation: Incyte Corporation

Overall contact:
Incyte Corporation Call Center, Phone: 1-855-463-3463

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

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.

Part 2: Overall Survival (OS)

Secondary outcome:

Progression-free survival (PFS)

Objective Response Rate

Duration of Response

Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 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.

Locations and Contacts

Incyte Corporation Call Center, Phone: 1-855-463-3463

Phoenix, Arizona, United States; Recruiting

Fayetteville, Arkansas, United States; Recruiting

Fresno, California, United States; Recruiting

La Jolla, California, United States; Recruiting

San Diego, California, United States; Recruiting

San Francisco, California, United States; Recruiting

Lone Tree, Colorado, United States; Recruiting

Norwich, Connecticut, United States; Recruiting

Southington, Connecticut, United States; Recruiting

Augusta, Georgia, United States; Recruiting

Joilet, Illinois, United States; Recruiting

Indianapolis, Indiana, United States; Recruiting

Lafayette, Indiana, United States; Recruiting

Kansas City, Kansas, United States; Recruiting

Detroit, Michigan, United States; Recruiting

Saint Louis, Missouri, United States; Recruiting

Reno, Nevada, United States; Recruiting

Lebanon, New Hampshire, United States; Recruiting

Mount Kisco, New York, United States; Recruiting

New York, New York, United States; Recruiting

Winston-Salem, North Carolina, United States; Recruiting

Canton, Ohio, United States; Recruiting

Portland, Oregon, United States; Recruiting

Chattanooga, Tennessee, United States; Recruiting

Knoxville, Tennessee, United States; Recruiting

Memphis, Tennessee, United States; Recruiting

Ogden, Utah, United States; Recruiting

Leesburg, Virginia, United States; Recruiting

Kennewick, Washington, United States; Recruiting

Seattle, Washington, United States; Recruiting

Additional Information

Starting date: March 2014
Last updated: May 28, 2015

Page last updated: August 23, 2015

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