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Study of LY2835219 for Mantle Cell Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01739309
First Posted: December 3, 2012
Last Update Posted: March 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
The purpose of this study is to estimate the disease control rate with LY2835219 for relapsed or refractory mantle cell lymphoma.

Condition Intervention Phase
Mantle Cell Lymphoma Drug: LY2835219 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of a CDK4/6 Inhibitor for Patients With Relapsed or Refractory Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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) ]

Estimated Enrollment: 20
Study Start Date: March 2013
Estimated Study Completion Date: March 2018
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2835219
200 milligram (mg) LY2835219 administered orally every 12 hours on days 1 through 28 of a 28-day cycle
Drug: LY2835219
Administered orally
Other Name: abemaciclib

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739309


Locations
France
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.
Lille, France, 59037
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.
Pessac, France, 33604
Germany
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.
Homburg, Germany, 66421
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.
Kassel, Germany, 34125
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.
Mainz, Germany, 55131
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.
Nürnberg, Germany, 90419
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.
Ulm, Germany, 89081
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01739309     History of Changes
Other Study ID Numbers: 13269
I3Y-MC-JPBB ( Other Identifier: Eli Lilly and Company )
2012-003614-14 ( EudraCT Number )
First Submitted: November 29, 2012
First Posted: December 3, 2012
Last Update Posted: March 9, 2017
Last Verified: March 2017

Keywords provided by Eli Lilly and Company:
Non- Hodgkins Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin