A Study of LY3007113 in Participants With Advanced Cancer

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

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