A Study for Patients With Pancreatic Cancer - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by (Responsible Party):	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

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:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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 2013
Estimated 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

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

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

Show 46 Study Locations

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:	January 20, 2012
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:

Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
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 February 09, 2012