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Phase 1 Completed N=89 Treatment

A Study of LY2228820 in Participants With Advanced Cancer

Source: ClinicalTrials.gov NCT01393990 ↗
Enrolled (actual)
89
Serious AEs
33.7%
Results posted
Mar 2020
Primary outcomePrimary: Number of Participants With Clinically Significant Effects (Physical Assessments and Safety Lab Tests) — 1; 3; 2; 3 Participants

Summary

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Clinically Significant Effects (Physical Assessments and Safety Lab Tests)
1; 3; 2; 3; 1; 1
SECONDARY
Recommended Dose for Phase 2 Studies
300
SECONDARY
Percentage of Participants With Best Overall Response [Complete Response (CR)+Partial Response (PR)+Stable Disease (SD)]
25.0; 33.3; 33.3; 33.3; 40.0; 33.3
SECONDARY
PK: Area Under the Concentration-Time Curve From Time Zero to 8 Hours (AUC0-8) of LY2228820
55.6; 257; 375; 445; 707; 1310
SECONDARY
PK: Maximum Plasma Concentration (Cmax) of LY2228820
14.7; 90.1; 144; 135; 202; 405
SECONDARY
Pharmacodynamics (PD): Number of Participants With Greater Than 50% Inhibition of p38 Mitogen-Activated Protein Kinase (MAPK) Activity on Day 1
14

Eligibility 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 (mRECIST)
  • 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 ≥ 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, participants should not receive grapefruit juice or treatment with a CYP3A4 inhibitor or inducer during the study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01393990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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