A Study for Patients With Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00839332
First received: February 6, 2009
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

The purpose of the Phase 1 portion of this study is to determine the safe dose of LY2603618 when given 24 hours after gemcitabine. This dose will then be used for the Phase 2 portion of the study. The Phase 2 portion of the study will evaluate whether LY2603618 when administered 24 hours after gemcitabine therapy is an effective treatment for patients with pancreatic cancer.


Condition Intervention Phase
Pancreatic Neoplasms
Drug: LY2603618
Drug: Gemcitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination With Gemcitabine in Patients With Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Phase 1: Determine the maximum tolerated dose for LY2603618 when administered after gemcitabine. [ Time Frame: Time of first dose until 28 days post dose ] [ Designated as safety issue: Yes ]
  • Phase 2: overall survival [ Time Frame: Baseline to date of death ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cmax of gemcitabine and LY2603618 [ Time Frame: Phase 1: During cycles 1 and 2 Phase 2: During cycle 1 ] [ Designated as safety issue: No ]
  • Overall tumor response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Electrocardiogram QTc prolongation [ Time Frame: Baseline and during Cycle 1 of both Phase 1 and Phase 2 for patients receiving LY2603618 ] [ Designated as safety issue: Yes ]
  • Time to disease progression [ Time Frame: Baseline to objective progression ] [ Designated as safety issue: No ]
  • Response rate in tumor size at 8 weeks and the relationship with overall survival [ Time Frame: Baseline to date of confirmed response and date of death from any cause ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: baseline to time of discontinuing gemcitabine and/or LY2603618 or baseline to time of starting of new therapy after discontinuing study treatment ] [ Designated as safety issue: No ]
  • AUC of gemcitabine and LY2603618 [ Time Frame: Phase 1: During cycles 1 and 2 Phase 2: During cycle 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: March 2009
Study Completion Date: December 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2603618/gemcitabine Drug: LY2603618
70-300 mg/m2 intravenous administered once per week for 3 weeks followed by 1 week of rest, repeating every 28 days for a minimum of 2 cycles and until disease progression
Drug: Gemcitabine
1000 mg/m2 intravenous administered once per week for 3 weeks followed by 1 week of rest, repeating every 28 days for a minimum of 2 cycles continuing until disease progression
Other Names:
  • Gemzar
  • LY188011
Active Comparator: Gemcitabine Drug: Gemcitabine
1000 mg/m2 intravenous administered once per week for 3 weeks followed by 1 week of rest, repeating every 28 days for a minimum of 2 cycles continuing until disease progression
Other Names:
  • Gemzar
  • LY188011

Detailed Description:

Phase 1 will be a dose escalation of doses 70 mg/m2 to 300 mg/m2 divided into 6 cohorts. Each patient will be assigned to a single cohort with no intrapatient dose escalation. Patients will received gemcitabine on days 1, 8, and 15 followed by LY2603618 on days 2, 9, and 16 of each 28 day cycle. The phase 1 portion will enroll approximately 26 patients total to determine the maximum tolerated dose to be carried into the phase 2 portion of the study.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with cancer that is metastatic and/or advanced during Phase 1
  • Diagnosed with pancreatic cancer that is metastatic and not amenable to surgery
  • Must be 18 years of age
  • Adequate hematological, liver, and renal functions
  • ECOG status 0-2

Exclusion Criteria:

  • Known hypersensitivity to gemcitabine
  • Pregnant or lactating females or refusal to use medically approved contraceptive precautions
  • Had prior treatment with radiotherapy involving more than 25% of marrow producing area
  • Have received treatment in the last 30 days with a drug which has not received regulatory approval for any indication at the time of study entry
  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: NCT00839332

  Hide Study Locations
Locations
United States, Florida
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.
Jacksonville, Florida, United States, 32224
United States, Georgia
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Athens, Georgia, United States, 30607
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Macon, Georgia, United States, 31201
United States, Idaho
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Post Falls, Idaho, United States, 83854
United States, Iowa
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Sioux City, Iowa, United States, 51101
United States, Michigan
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Ann Arbor, Michigan, United States, 48106
United States, Minnesota
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Rochester, Minnesota, United States, 55905
United States, North Dakota
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Fargo, North Dakota, United States, 58122
United States, Pennsylvania
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Danville, Pennsylvania, United States, 17822
United States, South Dakota
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Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
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Memphis, Tennessee, United States, 38119
United States, Texas
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San Antonio, Texas, United States, 78217
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The Woodlands, Texas, United States, 77380
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Tyler, Texas, United States, 75702
United States, Virginia
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Hampton, Virginia, United States, 23666
United States, Wisconsin
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Green Bay, Wisconsin, United States, 54307
Germany
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Berlin, Germany, 13353
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Frankfurt, Germany, 60596
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Freiburg, Germany, D-79106
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Hamburg, Germany, 20246
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Heilbronn, Germany, 74078
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Nürnberg, Germany, 90419
Italy
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Ancona, Italy, 60126
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Firenze, Italy, 50139
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Mendola, Italy, 47014
Netherlands
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Amsterdam, Netherlands, 1105 AZ
Romania
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Bucharest, Romania
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Cluj-Napoca, Romania, 400015
Spain
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Hospitalet De Llobregat, Spain, 08908
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Madrid, Spain, 28050
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 9AM-5PM 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: NCT00839332     History of Changes
Other Study ID Numbers: 12096, I2I-MC-JMMC
Study First Received: February 6, 2009
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration
Spain: Ministry of Health

Keywords provided by Eli Lilly and Company:
Pancreas
metastatic cancer
advanced cancer
Pancreatic cancer

Additional relevant MeSH terms:
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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 19, 2014