A Study of LY3007113 in Participants With Advanced Cancer

Lilly

Status and phase: Completed; Phase 1

Conditions: Metastatic Cancer

Treatments: Drug: LY3007113

Study type: Interventional

Funder types: Industry

Identifiers

NCT01463631

13513

I5Z-MC-JKBA (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

LY3007113

Experimental group

Description:

Study has a dose escalation phase (Part A) and dose confirmation phase (Part B). Participants in the dose escalation phase will receive 1 of 6 doses of LY3007113 administered orally every 12 hours for at least one cycle. Participants in the dose confirmation phase will receive the maximum tolerated dose from the dose escalation phase administered orally every 12 hours for at least 1 cycle. Three days prior to the start of the first cycle, participants will receive 1 dose at their assigned level to allow for the collection of single dose pharmacokinetics. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.

Treatment:

Drug: LY3007113