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A Study of LY2835219 in Japanese Participants With Advanced Cancer

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.
ClinicalTrials.gov Identifier: NCT02014129
Recruitment Status : Active, not recruiting
First Posted : December 18, 2013
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Lymphoma Drug: LY2835219 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY2835219 in Japanese Patients With Advanced Cancer
Actual Study Start Date : December 18, 2013
Actual Primary Completion Date : April 1, 2015
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY2835219
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.
Drug: LY2835219
Administered orally
Other Name: abemaciclib




Primary Outcome Measures :
  1. Number of Participants with LY2835219 Dose-Limiting Toxicities (DLT) [ Time Frame: Cycle 1 (32 Days) ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2835219 [ Time Frame: Cycle 1 (32 days): Predose on Day - 3 through Day 29 ]
  2. 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 ]
  3. Percentage of Participants with a Tumor Response [ Time Frame: Baseline to study completion (estimated as 5 months) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT02014129


Locations
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Japan
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.
Tokyo, Japan, 104-0045
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) Eli Lilly and Company

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02014129     History of Changes
Other Study ID Numbers: 15154
I3Y-JE-JPBC ( Other Identifier: Eli Lilly and Company )
First Posted: December 18, 2013    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 1, 2019

Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes