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A Study of LY3007113 in Participants With Advanced Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01463631
First Posted: November 2, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
This study evaluates the safety and tolerability of different doses of an experimental treatment in participants with advanced cancer.

Condition Intervention Phase
Metastatic Cancer Drug: LY3007113 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY3007113, a p38 MAPK Inhibitor, in Patients With Advanced Cancer

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of participants with clinically significant adverse events (AEs) (physical assessments and clinical lab tests) [ Time Frame: Baseline through study completion (approximately 35 months) ]

Secondary Outcome Measures:
  • Number of participants with tumor response in dose confirmation phase [ Time Frame: Baseline through study completion (approximately 35 months) ]
  • Pharmacokinetics: Area under the concentration versus time curve [ Time Frame: Predose up to 24 hours post administration of study drug (Cycle 1 and Day 1 of Cycle 2) ]
  • Pharmacokinetics: Maximum plasma concentration (Cmax) [ Time Frame: Predose up to 24 hours post administration of study drug (Cycle 1 and Day 1 of Cycle 2) ]

Estimated Enrollment: 36
Study Start Date: December 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: LY3007113
Administered orally

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463631


Locations
United States, California
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, 90404
United States, Texas
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, 78229
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01463631     History of Changes
Other Study ID Numbers: 13513
I5Z-MC-JKBA ( Other Identifier: Eli Lilly and Company )
First Submitted: October 28, 2011
First Posted: November 2, 2011
Last Update Posted: October 12, 2017
Last Verified: January 2014

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes