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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.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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.

Inclusion 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
- Serum creatinine Cockcroft and Gault formula:

- Absolute neutrophil count >/= 1.5 x 109/L, hemoglobin >/= 10 g/dL (can be corrected
by growth factor or transfusion), and platelet count >/=100 x 109/L

- Total bilirubin phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase
(AST) > 3 times ULN (in absence of liver metastases) or > 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 >/=1.5 cm in longest diameter for non-lymph nodes or >/=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 >/= 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 >/= 4
weeks before starting study treatment. Symptoms attributed to brain metastases must
be stable for >/= 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 >/=2, other than any grade
of alopecia or grade
- 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 >
II, unstable angina, myocardial infarction within the past 6 months, serious cardiac
arrhythmia

- Electrocardiogram with QTc interval >/=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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Eisai US Medical Services

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

E7389-G000-205

NCT ID:

NCT01104155

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
McLean, Virginia  22101
Kansas City, Kansas  66160
Denver, Colorado  
Charlotte, North Carolina  
Eugene, Oregon  
Providence, Rhode Island  02908
Las Vegas, Nevada  89109