A Study of LY3007113 in Participants With Advanced Cancer

Metastatic Cancer Clinical Trial

Official title:

A Phase 1 Study of LY3007113, a p38 MAPK Inhibitor, in Patients With Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463631
• Other study ID #: 13513
• Secondary ID: I5Z-MC-JKBA
• Status: Completed
• Phase: Phase 1
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• LY3007113
Administered orally

Locations

Country	Name	City	State
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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Percentage of Participants Who Achieved a Best Response of Either Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)	Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter without notable worsening of additional tumors that were qualitatively assessed.	Baseline through Study Completion (up to 170 Days)
Secondary	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
Secondary	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
Secondary	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