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A Study of LY2157299 in Participants With Pancreatic Cancer That is Advanced or Has Spread to Another Part of the Body

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: NCT02154646
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to evaluate the safety and side effects of LY2157299 in combination with gemcitabine in Japanese participants with pancreatic cancer that is advanced or has spread to another part of the body.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Drug: LY2157299 Drug: Gemcitabine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study of LY2157299 in Combination With Gemcitabine in Patients With Advanced or Metastatic Unresectable Pancreatic Cancer
Study Start Date : May 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY2157299 + Gemcitabine
150 mg LY2157299 is administered orally twice daily for 14 days followed by 14 days without study drug (28 day cycle.) Gemcitabine 1000 milligram per square meter will be administered intravenously (IV) on Days 8, 15, and 22 in each cycle (28 day cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Drug: LY2157299
Administered orally

Drug: Gemcitabine
Administered IV




Primary Outcome Measures :
  1. Number of Participants with LY2157299 Dose-Limiting Toxicities (DLT) [ Time Frame: Cycle 1 (28 days) ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2157299 [ Time Frame: Cycle 1: Predose on Day 1 through Day 28, Cycle 2 through last cycle: Predose on Day 1 (Cycle = 28 days; treatment estimated to last 4 cycles) ]
  2. PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2157299 [ Time Frame: Cycle 1: Predose on Day 1 through Day 28, Cycle 2 through last cycle: Predose on Day 1 (Cycle = 28 days; treatment estimated to last 4 cycles) ]
  3. PK: Cmax of Gemcitabine [ Time Frame: Cycle 1 (28 days): Predose on Day 8 through 2 hours after gemcitabine infusion on Day 8 ]
  4. PK: AUC of Gemcitabine [ Time Frame: Cycle 1 (28 days): Predose on Day 8 through 2 hours after gemcitabine infusion on Day 8 ]
  5. 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 diagnosis of adenocarcinoma of the pancreas that is locally advanced or metastatic and not amenable to resection with curative intent. These participants may have received prior chemotherapy, radiotherapy, cancer-related hormone therapy, or other investigational therapy as treatment or chemotherapy.
  • Participants with previous radical surgery for pancreatic cancer are eligible after progression is documented.
  • Have measurable disease or non-measurable disease, defined according to Response Evaluation Criteria in Solid Tumors (RECIST).
  • Have given written informed consent prior to any study-specific procedures.
  • Have adequate organ function.
  • Have a performance status of less than or equal 1 on the Eastern Cooperative Oncology Group (ECOG).
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
  • Prior radiation therapy for treatment of cancer is allowed to less than 25% of the bone marrow, and participants must have recovered from the acute toxic effects of their treatment prior to study enrollment. Prior radiation to the whole pelvis is not allowed.
  • Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug.

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the last 30 days of study enrollment, a clinical trial involving an investigational product or nonapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Have moderate or severe cardiac disease:

    • Myocardial infarction within 6 months prior to study enrollment, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension.
    • Documented major electrocardiogram (ECG) abnormalities at the investigator's discretion.
    • Major abnormalities documented by echocardiography with Doppler.
    • Have significantly elevated brain natriuretic peptide (BNP) or elevated Troponin I at screening local laboratory tests.
    • Predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress.
    • Have a history of cardiac or aortic surgery.
  • Have known positive tests for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus antibodies (HCVAbs).
  • Have symptomatic central nervous system (CNS) malignancy or metastasis.
  • Are unable to swallow tablets or capsules.
  • Are pregnant or breastfeeding.
  • Have serious preexisting medical conditions as follows:

    • Presence or history of interstitial pneumonitis.
    • Uncontrollable severe diabetes.
    • Presence of serious active infection or uncontrollable chronic infection.
    • Presence of liver cirrhosis with Child-Pugh Stage of B or C.
    • Other serious conditions judged by the investigator.
  • Have previous or concurrent malignancy except for basal or squamous cell skin cancer (non-melanoma) and/or preinvasive carcinoma of the cervix, mucosal gastrointestinal or uterine carcinoma, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to enrollment.
  • Have endocrine pancreatic tumors or ampullary cancer.
  • Have current hematological malignancies.
  • Have previously completed or withdrawn from this study or any other study investigating LY2157299.
  • Have known allergies to LY2157299 or gemcitabine or any ingredient of LY2157299 or gemcitabine formulations.
  • Are assessed as inadequate for the study by the investigator.

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): NCT02154646


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.
Chiba, Japan, 277 8577
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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02154646    
Other Study ID Numbers: 14855
H9H-JE-JBAO ( Other Identifier: Eli Lilly and Company )
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs