Study of LY2835219 for Mantle Cell Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01739309
First received: November 29, 2012
Last updated: May 16, 2014
Last verified: May 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Progression-Free Survival [ Time Frame: Date of First Dose until Diease Progression or Death Due to Any Cause (Estimated up to 28 Months) ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Date of First Dose until Death Due to Any Cause (Estimated up to 28 Months) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219 and its metabolites [ Time Frame: Predose up to 10 Hours Postdose ] [ Designated as safety issue: No ]
  • PK - Area Under the Concentration-Time Curve (AUC) of LY283219 and its metabolites [ Time Frame: Predose up to 10 Hours Postdose ] [ Designated as safety issue: No ]
  • PK - Terminal Half Life (T 1/2) of LY2835219 and its metabolites [ Time Frame: Predose up to 10 hours Postdose ] [ Designated as safety issue: No ]
  • PK: Volume of Distribution (Vd) of LY2835219 and its metabolites [ Time Frame: Predose up to 10 Hours Postdose ] [ Designated as safety issue: No ]
  • PK: Clearance (CL) of LY2835219 and its metabolites [ Time Frame: Predose up to 10 Hours Postdose ] [ Designated as safety issue: No ]
  • Event-Free Survival [ Time Frame: Baseline until Disease Progression or Death Due to Any Cause (Estimated up to 28 Months) ] [ Designated as safety issue: No ]
  • Time to Disease Progression [ Time Frame: Baseline until Disease Progression (Estimated up to 28 Months) ] [ Designated as safety issue: No ]
  • Disease-Free Survival [ Time Frame: Baseline until Disease Progression (Estimated up to 28 Months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: January 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739309

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

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. Recruiting
Lille, France, 59037
Contact: Eli Lilly         
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. Recruiting
Paris, France, 75475
Contact: Eli Lilly         
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. Recruiting
Pessac, France, 33604
Contact: Eli Lilly         
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. Recruiting
Rennes, France, 35033
Contact: Eli Lilly         
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. Recruiting
Göttingen, Germany, 37075
Contact: Eli Lilly         
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. Recruiting
Homburg, Germany, 66421
Contact: Eli Lilly         
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. Recruiting
Kassel, Germany, 34125
Contact: Eli Lilly         
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. Recruiting
Mainz, Germany, 55131
Contact: Eli Lilly         
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. Recruiting
Nürnberg, Germany, 90419
Contact: Eli Lilly         
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. Recruiting
Ulm, Germany, 89081
Contact: Eli Lilly         
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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01739309     History of Changes
Other Study ID Numbers: 13269, I3Y-MC-JPBB, 2012-003614-14
Study First Received: November 29, 2012
Last Updated: May 16, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on July 20, 2014