Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01104155
First received: April 12, 2010
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

This is a Phase 2, multicenter, randomized study of two different dose regimens of eribulin mesylate in combination with intermittent erlotinib in patients with previously treated, advanced non-small cell lung cancer.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: eribulin mesylate + erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Purpose of This Study is to Investigate Two Different Dose Regimens of Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-small Cell Lung Cancer.

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Progression-Free Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Disease Control Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: November 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: eribulin mesylate, 21 day cycle Drug: eribulin mesylate + erlotinib
21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle.
Active Comparator: eribulin mesylate, 28 day cycle Drug: eribulin mesylate + erlotinib
28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Histologically confirmed non-small cell lung cancer (NSCLC)
  • At least one prior platinum-based doublet anti-cancer treatment for recurrent or advanced NSCLC
  • Disease progression during or after the last anti-cancer therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
  • Serum creatinine less than or equal to 2.0 mg/dL or creatinine clearance 40 mL/min according to Cockcroft and Gault formula:
  • Absolute neutrophil count greater than or equal to 1.5 x 109/L, hemoglobin greater than or equal to 10 g/dL (can be corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 109/L
  • Total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 times ULN (in the case of liver metastases less than or equal to 5 times ULN). In case AP is greater than 3 times ULN (in absence of liver metastases) or greater than 5 times ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.
  • At least one lesion of greater than or equal to 1.5 cm in longest diameter for non-lymph nodes or greater than or equal to 1.5 cm in shortest diameter for lymph nodes which is serially measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.17

    • Males and females, age greater than or equal to 18 years
    • Provide written informed consent
    • Are willing and able to comply with all aspects of the protocol
    • Females of childbearing potential must have a negative serum beta-human chorionic gonadotropin (Beta-hCG) at Visit 1 (Screening) and a negative urine pregnancy test prior to starting study drug (Visit 2). Female subjects of childbearing potential must agree to be abstinent or to use highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomised partner) having starting for at least one menstrual cycle prior to starting study drugs and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use a highly effective method of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drugs and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously).

Exclusion criteria:

  • Prior therapy with eribulin or an tyrosine kinase inhibitor of the epidermal growth factor receptor
  • Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued steroids for this indication for greater than or equal to 4 weeks before starting study treatment. Symptoms attributed to brain metastases must be stable for greater than or equal lto 4 weeks before starting study treatment; radiographic stability should be determined by comparing contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) brain scan performed during screening to a prior scan performed 4 weeks earlier.
  • Existing anti-cancer therapy-related toxicities of grade greater than or equal to 2, other than any grade of alopecia or grade less than or equal to 2 neuropathy, which are acceptable
  • Current smokers who will not stop smoking one week prior to treatment and during the study
  • History of congestive heart failure with New York Heart Association (NYHA) Grade greater than II, unstable angina, myocardial infarction within the past 6 months, serious cardiac arrhythmia
  • Electrocardiogram with QTc interval greater than or equal to 500 msec based upon Bazett's formula (QTcB)
  • Females who are pregnant (positive Beta-hCG test) or breastfeeding
  • Subject with hypersensitivity to eribulin and /or erlotinib or any of the excipients
  • Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
  • Subjects who are known to be human immunodeficiency virus (HIV) positive, because the neutropenia caused by the study treatments may make such subjects particularly susceptible to infection
  • Subjects with active viral hepatitis (A, B, or C) as demonstrated by positive serology
  • Radiotherapy, chemotherapy, biological therapy or investigational agents within 2 weeks prior to start of study treatment
  • Meningeal carcinomatosis
  • History of drug or alcohol dependency or abuse within approximately the last 2 years
  • Medically unfit to receive the study drug or unsuitable for any other reason according to investigator judgment
  • Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the study
  • Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
  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: NCT01104155

  Show 60 Study Locations
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Eisai US Medical Services Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01104155     History of Changes
Other Study ID Numbers: E7389-G000-205
Study First Received: April 12, 2010
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014