A Study of LY2228820 in Patients With Advanced Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01393990
First received: July 12, 2011
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

The objective of this study is to determine a safe dose of LY2228820 that may be given to patients with advanced cancer. Part A of this study will consist of dose escalation, and Part B will consist of dose confirmation.


Condition Intervention Phase
Advanced Cancer
Drug: LY2228820
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of an Oral p38 MAPK Inhibitor in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of participants with clinically significant effects (physical assessments and safety lab tests) [ Time Frame: Baseline through study completion (approximately 41 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recommended dose for Phase 2 studies [ Time Frame: Baseline to study completion (approximately 41 months) ] [ Designated as safety issue: Yes ]
  • Number of participants with tumor response [ Time Frame: Baseline through study completion (approximately 41 months) ] [ Designated as safety issue: No ]
  • Pharmacokinetics, area under the concentration-time curve (AUC) [ Time Frame: Days 1, 14, 15, and 16 of Cycle 1, Day 1 of Cycle 2 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, maximum plasma concentration (Cmax) [ Time Frame: Days 1, 14, 15, and 16 of Cycle 1, Day 1 of Cycle 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2008
Study Completion Date: December 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2228820

Administered orally, for two (2) 28-day cycles.

Patients demonstrating clinical benefit may receive treatment beyond 2 cycles until one or more of the criteria for discontinuation are fulfilled.

Drug: LY2228820
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have histological or cytological evidence of a diagnosis of cancer (including lymphoma) that is advanced or metastatic disease for which no therapy of higher priority (approved therapies or therapies with published substantial evidence of effectiveness) is available, or for whom no standard therapy exists
  • Have the presence of measurable or nonmeasurable disease as defined by Modified Response Evaluation Criteria in Solid Tumors (RECIST)
  • Have adequate hematologic, renal, and hepatic organ function
  • Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, or other investigational therapy for at least 14 days (42 days for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy
  • Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug.
  • Females with child bearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug.
  • Have an estimated life expectancy of greater than or equal to 12 weeks
  • Are able to swallow capsules and/or tablets

Exclusion Criteria:

  • Have received treatment within 14 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication
  • Have a history of major surgical resection involving the stomach or small bowel, or have serious preexisting medical conditions (based on judgment of the investigator)
  • Have symptomatic central nervous system malignancy or metastasis (screening is not required)
  • Have a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
  • Have an active hematologic malignancy other than lymphoma
  • Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb). Screening at baseline will not be required for enrollment
  • Concurrent administration of any immunosuppressive therapy
  • Females who are pregnant or lactating
  • Have received, within 7 days of the initial dose of study drug, either grapefruit juice or treatment with a drug that is a known inhibitor or inducer of Cytochrome P450 Enzyme 3A4 (CYP3A4). In addition, patients should not receive grapefruit juice or treatment with a CYP3A4 inhibitor or inducer during the study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393990

Locations
United States, Minnesota
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.
Rochester, Minnesota, United States
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
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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01393990     History of Changes
Other Study ID Numbers: 12284, I1D-MC-JIAD
Study First Received: July 12, 2011
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 31, 2014