A Study for Participants With Advanced Cancer



Status:Completed
Conditions:Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/8/2018
Start Date:July 2007
End Date:May 2012

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A Phase I Study of LY2523355 in Patients With Advanced Cancer

This study is being conducted to determine the safety of LY2523355 for the treatment of
advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).

This study is a multi-center, non-randomized, open label, dose-escalation, Phase 1 study of
intravenous LY2523355 in participants with advanced and/or metastatic cancer (including
Non-Hodgkin's Lymphoma) for whom no treatment of higher priority exists.

Inclusion Criteria:

- Have a diagnosis of advanced and/or metastatic cancer (solid tumors or Non-Hodgkin's
lymphoma) that is refractory to standard therapy or for which no proven effective
therapy exists. Participants entering Part B of the study must also have a tumor that
is safely amenable to serial biopsies

- Have the presence of measurable or nonmeasurable disease as defined by the Response
Evaluation Criteria in Solid Tumors (RECIST, Therasse et al. 2000) or Revised
International Working Group Lymphoma Response Criteria (Cheson et al. 2007)

- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
scale

- Have discontinued all previous therapies for cancer, including chemotherapy,
radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at
least 28 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment

- Males and females with reproductive potential must agree to use medically approved
contraceptive precautions during the trial and for 3 months following the last dose of
study drug

- Females with child bearing potential must have had a negative urine or serum pregnancy
test less than or equal to 7 days prior to the first dose of study drug

- Have an estimated life expectancy of greater than or equal to 12 weeks

Exclusion Criteria:

- 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 they are not currently receiving
corticosteroids and/or anticonvulsants. Screening of asymptomatic participants without
history of CNS metastases is not required

- Have current acute or chronic leukemia

- Have had an autologous or allogenic bone marrow transplant

- Have the following conduction abnormalities: PR >250 milliseconds (msec), second
degree or complete atrioventricular (AV) block, intraventricular conduction delay
(IVCD) with QRS ≥120 msec, left branch bundle block (LBBB), right branch bundle block
(RBBB), Wolf-Parkinson- White syndrome (WPW), left anterior fascicular block (LAFB),
left posterior fascicular block (LPFB), or other conduction abnormality that in the
opinion of the investigator would preclude safe participation in this study.

- Females who are pregnant or lactating

- Known hypersensitivity to pegfilgrastim or filgrastim
We found this trial at
2
sites
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mi
from
Albuquerque, NM
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mi
from
Philadelphia, PA
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