A Study of LY3007113 in Participants With Advanced Cancer

Completed · Phase 1

Conditions studied: Metastatic Cancer

In brief

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

Key facts

Study ID

NCT01463631

Run by

Eli Lilly and Company

People needed

27

Starts

2011-12-01

Expected to finish

2013-12-01

Last updated by the study team

2018-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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