A Study of LY3007113 in Participants With Advanced Cancer

NCT ID: NCT01463631

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-12-31

Brief Summary

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

Conditions

Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LY3007113

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.

Group Type: EXPERIMENTAL

LY3007113

Intervention Type: DRUG

Administered orally

Interventions

LY3007113

Administered orally

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

United States

Other Identifiers

I5Z-MC-JKBA

Identifier Type: OTHER

Identifier Source: secondary_id

13513

Identifier Type: -

Identifier Source: org_study_id