This trial is active, not recruiting.

Conditions neoplasm metastasis, lymphoma
Treatment ly2835219
Phase phase 1
Target CDK4
Sponsor Eli Lilly and Company
Start date December 2013
End date April 2015
Trial size 12 participants
Trial identifier NCT02014129, 15154, I3Y-JE-JPBC


The main purpose of this study is to evaluate safety and side effects of LY2835219 in Japanese participants with advanced cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Oral LY2835219 will be administered in escalating dose cohorts twice daily in 28-day cycles (Cycle 1: 32-days). Treatment with LY2835219 may continue until disease progression, unacceptable toxicity, or other discontinuation criteria are met.
ly2835219 abemaciclib
Administered orally

Primary Outcomes

Number of Participants with LY2835219 Dose-Limiting Toxicities (DLT)
time frame: Cycle 1 (32 Days)

Secondary Outcomes

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2835219
time frame: Cycle 1 (32 days): Predose on Day - 3 through Day 29
Pharmacokinetics (PK): Area under the Plasma Concentration Versus Time Curve (AUC) of LY2835219
time frame: Cycle 1 (32 days): Predose on Day -3 through Day 29
Percentage of Participants with a Tumor Response
time frame: Baseline to study completion (estimated as 5 months)

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Have histological or cytological evidence of a diagnosis of cancer (either a solid tumor or a lymphoma) that is advanced and/or metastatic - Must be, in the judgment of the investigator, an appropriate candidate for the experimental therapy after available standard therapies have failed to provide clinical benefit for their disease - Have the presence of measurable or non-measurable disease as defined by the Response Evaluation Criteria in Solid Tumors Guideline Version 1.1, or the Revised Response Criteria for Malignant Lymphoma Guideline - Have adequate organ function - Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, and investigational therapy, for at least 21 days before the first dose of study drug and recovered from the acute effects of any such therapy - Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug - Females with child bearing potential: must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test ≤7 days before the first dose of study drug. - A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, the female must stop breastfeeding from the day of the first study drug administration until at least 3 months after the last administration - Have an estimated life expectancy of ≥12 weeks - Are able to swallow capsules Exclusion Criteria: - Have received treatment within 21 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication - Have a medical history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (e.g., ventricular tachycardia and ventricular fibrillation) or sudden cardiac arrest - Have a baseline with any of the following findings on screening electrocardiogram (ECG): ventricular tachycardia, ventricular fibrillation, abnormal QTc using Bazett's formula (QTcB) (defined as ≥470 milliseconds), or evidence of acute myocardial ischemia - Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel) - Have symptomatic central nervous system (CNS) malignancy or metastasis. For asymptomatic participants without history of CNS malignancy or metastases - Have evidence or history of a leukemia - Have received a stem-cell transplant. As an exception, a participant with lymphoma who received an autologous stem-cell transplant is eligible for the study, if more than 75 days have passed before the initial dose of study drug - Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV], hepatitis B, or hepatitis C)

Additional Information

Official title A Phase 1 Study of LY2835219 in Japanese Patients With Advanced Cancer
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.