A Study for Patients With Pancreatic Cancer - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00839332

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 I Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination With Gemcitabine in Patients With Pancreatic Cancer

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
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
LY2603618/gemcitabine: Experimental	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
Gemcitabine: Active Comparator	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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839332

Contacts

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

1-317-615-4559

Locations

United States, Arizona
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
Scottsdale, Arizona, United States, 85258
Contact: Eli Lilly
United States, Minnesota
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
Rochester, Minnesota, United States, 55905
Contact: Eli Lilly
United States, Texas
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
The Woodlands, Texas, United States, 77380
Contact: Eli Lilly
Spain
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
Madrid, Spain, 28050
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 9AM-5PM Eastern time (UTC/GMT-5 hours, EST)

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	12096, I2I-MC-JMMC
Study First Received:	February 6, 2009
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00839332 History of Changes
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

Study placed in the following topic categories:

Antimetabolites
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Immunosuppressive Agents
Pancrelipase
Antiviral Agents

Digestive System Diseases
Radiation-Sensitizing Agents
Neoplasm Metastasis
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009