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Phase 1 Completed N=26 Randomized Treatment

A Study of Abemaciclib (LY2835219) in Native Chinese Participants With Advanced and/or Metastatic Cancers

Source: ClinicalTrials.gov NCT02919696 ↗
Enrolled (actual)
26
Serious AEs
24.0%
Results posted
Sep 2020
Primary outcomePrimary: Number of Participants With One or More Drug Related Adverse Events — 12; 13 Participants

Summary

The purpose of this study is to determine the safety of the study drug known as abemaciclib in native Chinese participants with advanced and/or metastatic cancers.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With One or More Drug Related Adverse Events
12; 13
SECONDARY
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib and Its Metabolites Single Dose
204; 210
SECONDARY
PK: Maximum Concentration (Cmax) of Abemaciclib and Its Metabolites (Twice Daily Dosing)
205; 267; 320
SECONDARY
PK: Area Under Concentration Time Curve (AUC) From Time Zero to 12 Hours (AUC [0-12]) of Abemaciclib and Its Metabolites Single Dose
1700; 1740
SECONDARY
PK: AUC From Time Zero to 12 Hours (AUC [0-12]) of Abemaciclib and Its Metabolites (Twice Daily Dosing)
2190; 2770; 3270
SECONDARY
PK: AUC From Time Zero to Infinity (AUC[0-inf]) of Abemaciclib and Its Metabolites Single Dose
6790; 7580
SECONDARY
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
8.3; 7.7

Eligibility Criteria

Inclusion Criteria

  • The participant must have histological or cytological evidence of cancer which is advanced and/or metastatic, and is an appropriate candidate for experimental therapy in the judgment of the investigator, after available standard therapies have ceased to provide clinical benefit.
  • Have the presence of measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  • Are native Chinese men or women.
  • Have adequate organ function, including:
  • Hematologic: Absolute neutrophil count (ANC) ≥1.5 x 109/Liters (L), platelets ≥100 x 109/L, and hemoglobin ≥9 grams per deciliter. Participants may receive erythrocyte transfusions to achieve this hemoglobin level or platelet transfusions to achieve platelet levels at the discretion of the investigator; however, initial study drug treatment must not begin earlier than the day after transfusion.
  • Hepatic: Bilirubin ≤1.5 times upper limits of normal (ULN), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3.0 times ULN.
  • Renal: Serum creatinine ≤1.2 milligrams per deciliter (mg/dL) for males or ≤1.0 mg/dL for females.
  • Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Recovered from the acute effects of therapy (treatment- related toxicity resolved to baseline) except for residual alopecia.
  • Have an estimated life expectancy of ≥12 weeks.

Exclusion Criteria

  • Have received previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) within 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug.
  • Have an acute leukemia or other relevant cancers at the discretion of the investigator.
  • Females who are pregnant or lactating.
  • Participants consuming drugs or foods that are known to be inducers (for example, grapefruit juice, phenytoin, carbamazepine) or strong inhibitors of CYP3A4 should be excluded during Cycle 1.
  • Have history or evidence of central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic participants without history of CNS metastases is not required for enrollment.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02919696). 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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