A Study of LY3007113 in Participants With Advanced Cancer

NCT01463631 | Completed Phase 1 Results

• 2 other identifiers: 13513I5Z-MC-JKBA
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinically Significant Adverse Events (AEs) (Physical Assessments and Clinical Lab Tests)

  Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after randomization. A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

  Baseline through Study Completion (up to 170 Days)

Secondary Outcomes (4)

• The Percentage of Participants Who Achieved a Best Response of Either Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)

  Baseline through Study Completion (up to 170 Days)

• Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of Single Dose LY3007113

  Cycle 1 Days -3, -2, -1, 1: Predose to 48 hours Postdose

• Pharmacokinetics: Area Under the Concentration Versus Time Curve From 0 to Tau (AUC[0-tau]) of Multiple Dose LY3007113

  Cycle 1 Days 28 and 29, Cycle 2 Day 1: Predose to 24 hours Postdose

• Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3007113

  Cycle 1 Day -3 (single dose): Predose to 48 hours Postdose; Day 28 (multiple dose): Predose to 24 hours Postdose

Study Arms (1)

LY3007113

EXPERIMENTAL

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.

Drug: LY3007113

Interventions

LY3007113 DRUG

Administered orally

LY3007113

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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.

Santa Monica, California, 90404, United States

Location

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, 78229, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 2, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 7, 2018
• Results First Posted: August 7, 2018

Record last verified: 2018-07

Locations

US (2)