A Study for Participants With Small-Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/6/2017
Start Date:December 2009
End Date:July 2012

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A Phase 2 Study of LY2523355 in Patients With Extensive-Stage Small-Cell Lung Cancer

Part A: This study evaluates an experimental treatment in participants with extensive-disease
in small-cell lung cancer.

Part B: This study evaluates an experimental treatment in participants with extensive-disease
in small-cell lung cancer.


Inclusion Criteria:

- Have histological or cytological evidence of extensive-disease small-cell lung cancer

- Have the presence of measurable disease as defined by the Response Evaluation Criteria
in Solid Tumors (RECIST 1.1)

- Have received at least 1 prior chemotherapy regimen with agents known to provide
clinical benefit for small-cell lung cancer and be, in the opinion of the
investigator, an appropriate candidate for experimental therapy

- Have discontinued all previous therapies for cancer, including chemotherapy, biologic
therapy, hormone therapy, or radiotherapy. Participants must have recovered from the
acute effects of therapy (except alopecia and fatigue) before study enrollment

- Part A: Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group
scale

- Part B: Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group
scale

Exclusion Criteria:

- Have received treatment within 28 days of the first dose of LY2523355 with a drug that
has not received regulatory approval for any indication

- Have a mixed histological diagnosis of small-cell lung cancer and non-small-cell lung
cancer

- Have serious preexisting medical conditions that, in the opinion of the investigator,
would preclude participation in this study

- Part A: Have symptomatic, untreated, or uncontrolled central nervous system (CNS)
metastases. Participants with treated CNS metastases are eligible provided their
disease is radiographically stable, asymptomatic, and corticosteroid use has been
discontinued for at least 2 weeks prior to the first dose of study drug. Screening of
asymptomatic participants without history of CNS metastases is not required

- Part B: Have symptomatic, untreated, or uncontrolled CNS metastases or a history of
CNS metastases. Participants who have received prophylactic radiation are not
excluded. Screening of asymptomatic participants without history of CNS metastases is
not required
We found this trial at
9
sites
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mi
from
Athens, GA
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mi
from
Albuquerque, NM
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Charleston, South Carolina 29412
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mi
from
Charleston, SC
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mi
from
Cherry Hill, NJ
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mi
from
Marietta, GA
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mi
from
Memphis, TN
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mi
from
Scarborough, ME
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mi
from
Seoul,
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mi
from
Torrington, CT
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