A Study of LY3007113 in Participants With Advanced Cancer



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/9/2018
Start Date:December 2011
End Date:December 2013

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A Phase 1 Study of LY3007113, a p38 MAPK Inhibitor, in Patients With Advanced Cancer

This study evaluates the safety and tolerability of different doses of an experimental
treatment in participants with advanced cancer.


Inclusion Criteria:

- Have histological or cytological evidence of a diagnosis of cancer that is advanced
and/or metastatic for which available standard therapies have failed to provide
clinical benefit for their disease

- For Dose Escalation (Part A): cancer, either a solid tumor or a lymphoma

- For Dose Confirmation (Part B): cancer, either a solid tumor or a lymphoma

- Have the presence of measureable or non-measureable disease (Part A) or measureable
disease (Part B) as defined by the Response Evaluation Criteria in Solid Tumors or the
Revised Response Criteria for Malignant Lymphoma

- Have adequate hematologic, hepatic and renal function

- Have a performance status less than or equal to 2 on the Eastern Cooperative Oncology
Group scale

- Have discontinued all previous therapies for cancer (including chemotherapy,
radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or
14 days for nonmyelosuppressive agents

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

- Are able to swallow capsules

Exclusion Criteria:

- Have an echocardiogram with clinically significant abnormalities

- For Dose Escalation (Part A): Have central nervous system malignancy or metastasis

- For Dose Confirmation (Part B): Have symptomatic central nervous system malignancy or
metastasis

- Have an acute leukemia

- Have a history of any other cancer (except non-melanoma skin cancer or carcinoma
in-situ of the cervix), unless in complete remission and stopped all therapy for that
disease for a minimum of 3 years

- Have received an autologous or allogeneic stem-cell transplant within 75 days of the
initial dose of study drug
We found this trial at
2
sites
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mi
from
Santa Monica, CA
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mi
from
San Antonio, TX
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