Status:
COMPLETED
A Study of LY3007113 in Participants With Advanced Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study evaluates the safety and tolerability of different doses of an experimental treatment in participants with advanced cancer.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01463631
Start Date
December 1 2011
End Date
December 1 2013
Last Update
August 7 2018
Active Locations (2)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Santa Monica, California, United States, 90404
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Antonio, Texas, United States, 78229