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Completed

NCT Number: NCT01463631

A Study of LY3007113 in Participants With Advanced Cancer

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

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Key information

Conditions

Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary 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., Santa Monica, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3007113

Drug

Administered orally

Primary outcomes

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

    Time frame: Baseline through Study Completion (up to 170 Days)

    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.

Secondary outcomes

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

    Time frame: Baseline through Study Completion (up to 170 Days)

    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.

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

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

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

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

  4. Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3007113

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 2, 2011
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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