Overview

This trial is active, not recruiting.

Condition mantle cell lymphoma
Treatment ly2835219
Phase phase 2
Target CDK4
Sponsor Eli Lilly and Company
Start date March 2013
End date September 2015
Trial size 20 participants
Trial identifier NCT01739309, 13269, 2012-003614-14, I3Y-MC-JPBB

Summary

The purpose of this study is to estimate the disease control rate with LY2835219 for relapsed or refractory mantle cell lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
200 milligram (mg) LY2835219 administered orally every 12 hours on days 1 through 28 of a 28-day cycle
ly2835219 abemaciclib
Administered orally

Primary Outcomes

Measure
Proportion of Participants who Achieve Best Overall Disease Response of Complete Response (CR), Complete Response unconfirmed (CRu), Partial Response (PR) or Stable Disease (SD)
time frame: Baseline until Disease Progression or Start of New Anticancer Therapy (Estimated up to 28 Months)

Secondary Outcomes

Measure
Proportion of Participants who Achieve Best Overall Disease Response of CR, CRu or PR
time frame: Baseline until Disease Progression (Estimated up to 28 Months)
Duration of Response
time frame: Date of CR, CRu or PR until Disease Progression or Death Due to Any Cause (Estimated up to 28 Months)
Progression-Free Survival
time frame: Date of First Dose until Diease Progression or Death Due to Any Cause (Estimated up to 28 Months)
Overall Survival
time frame: Date of First Dose until Death Due to Any Cause (Estimated up to 28 Months)
Change from Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Total Score and Subscales
time frame: Baseline, 30 Day Post Therapy (Estimated up to 28 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219 and its metabolites
time frame: Predose up to 10 Hours Postdose
PK - Area Under the Concentration-Time Curve (AUC) of LY283219 and its metabolites
time frame: Predose up to 10 Hours Postdose
PK - Terminal Half Life (T 1/2) of LY2835219 and its metabolites
time frame: Predose up to 10 hours Postdose
PK: Volume of Distribution (Vd) of LY2835219 and its metabolites
time frame: Predose up to 10 Hours Postdose
PK: Clearance (CL) of LY2835219 and its metabolites
time frame: Predose up to 10 Hours Postdose
Event-Free Survival
time frame: Baseline until Disease Progression or Death Due to Any Cause (Estimated up to 28 Months)
Time to Disease Progression
time frame: Baseline until Disease Progression (Estimated up to 28 Months)
Disease-Free Survival
time frame: Baseline until Disease Progression (Estimated up to 28 Months)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Have a diagnosis of relapsed or refractory Mantle Cell Lymphoma (MCL) according to the World Health Organization (WHO) classification that has relapsed after, or been refractory to, available standard treatments. However, participants who are intolerant of, or unable to receive a standard treatment are not required to have MCL that has relapsed after, or been refractory to, that specific standard treatment. Pathology must be reviewed and confirmed at the investigational site where participant is entered prior to enrollment - Have disease that is assessable according to the Response Criteria for Non- Hodgkin's Lymphomas - Have given written informed consent prior to any study-specific procedures - Have adequate organ function including: - Hematologic: Absolute neutrophil count (ANC) ≥1.5 x 10^9/Liter (L), platelets ≥75 x 10^9/L, and hemoglobin ≥8 grams per deciliter (g/dL) - Hepatic: Bilirubin ≤1.5 times upper limits of normal (ULN) and alanine aminotransferase (ALT) ≤3.0 times ULN - Renal: Estimated creatinine clearance ≥50 milliliter per minute (ml/min) - Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 - Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (treatment-related toxicity resolved to baseline) except for residual alopecia - Are willing to make themselves available for the duration of the study and to follow study procedures - Are amenable to compliance with protocol schedules and testing - 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 a negative serum pregnancy test within 14 days of the first dose of study drug - Have a life expectancy of ≥12 weeks - Are able to swallow capsules Exclusion Criteria: - Are currently enrolled in, or discontinued within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively, a clinical trial involving an investigational product or non-approved use of a drug or device other than the study drug used in this study, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study - Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, pneumonia, inflammatory bowel disease, history of major surgical resection involving the stomach or small bowel) - Have symptomatic metastasis to the central nervous system (CNS). Participants may have CNS metastasis that is radiographically or clinically stable for at least 14 days prior to receiving study drug, regardless of whether they are receiving corticosteroids - Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug. In addition, recipients of an allogenic stemcell transplant must have discontinued immunosuppressive therapy at least 14 days before study drug administration with no more than Grade 1 acute graft versus-host disease on Day 1 of Cycle 1 - Females who are pregnant or lactating - Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen [HBSAg], or hepatitis C antibodies). Screening is not required for enrollment - Have a baseline electrocardiogram (ECG) with any of the following findings: ventricular tachycardia, ventricular fibrillation, abnormal QTcB (defined as ≥450 milliseconds for males and ≥470 milliseconds for females), or evidence of acute myocardial ischemia

Additional Information

Official title Phase 2 Study of a CDK4/6 Inhibitor for Patients With Relapsed or Refractory Mantle Cell Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.