A Study for Participants With Pancreatic Cancer

NCT ID: NCT00839332

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of the Phase 1 portion of this study was to determine the dose of LY2603618 that can be safely administered 24 hours after gemcitabine treatment. This dose was then used for the Phase 2 portion of the study. The Phase 2 portion of the study evaluated whether LY2603618, when administered 24 hours after gemcitabine therapy, was an effective treatment for participants with pancreatic cancer.

Detailed Description

Phase 1 included a dose escalation of LY2603618 doses from 70 milligrams/meter squared (mg/m^2) to 250 mg/m^2 divided into 5 cohorts. Each participant was assigned to a single cohort with no intra-participant dose escalation. Phase 1 also included an expansion cohort where participants received a flat dose of 200 or 230 mg LY2603618. Participants received gemcitabine on Days 1, 8, and 15, followed by LY2603618 on Days 2, 9, and 16 of each 28-day cycle. The purpose of the Phase 1 portion was to determine the maximum tolerated LY2603618 dose to be carried into the Phase 2 portion of the study.

Conditions

Pancreatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LY2603618 + Gemcitabine

Participants participated in Phase 1 or 2.

LY2603618 (Phase 1): 70 to 250 milligrams/meter squared (mg/m^2) LY2603618 as a 1-hour continuous intravenous (IV) infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression (DP). Participants received LY2603618 as part of the dose escalation cohort (dose of 70, 105, 150, 200, or 250 mg/m^2) or the expansion cohort (flat dose of 200 mg or 230 mg).

LY2603618 (Phase 2): 230 mg LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until DP.

Gemcitabine (Phase 1 and 2): 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until DP. Participants received gemcitabine 24 hours prior to LY2603618 administration.

Group Type: EXPERIMENTAL

LY2603618

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Gemcitabine

Participants participated in Phase 2 only.

Gemcitabine (Phase 2): 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: DRUG

Interventions

LY2603618

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Other Intervention Names

Gemzar; LY188011

Eligibility 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 at least 18 years of age
• Adequate hematological, liver, and renal functions
• Eastern Cooperative Oncology Group (ECOG) status of 0 to 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

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.

Athens, Georgia, United States

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.

Macon, Georgia, United States

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.

Post Falls, Idaho, United States

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Sioux City, Iowa, United States

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Ann Arbor, Michigan, United States

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Rochester, Minnesota, United States

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Fargo, North Dakota, United States

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Danville, Pennsylvania, United States

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Sioux Falls, South Dakota, United States

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Memphis, Tennessee, United States

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San Antonio, Texas, United States

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The Woodlands, Texas, United States

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Tyler, Texas, United States

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Hampton, Virginia, United States

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Green Bay, Wisconsin, United States

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Berlin, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Hamburg, , Germany

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Heilbronn, , Germany

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Nuremberg, , Germany

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Ancona, , Italy

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Florence, , Italy

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Mendola, , Italy

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Amsterdam, , Netherlands

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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L'Hospitalet de Llobregat, , Spain

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Madrid, , Spain

Countries

United States; Germany; Italy; Netherlands; Romania; Spain

References

Laquente B, Lopez-Martin J, Richards D, Illerhaus G, Chang DZ, Kim G, Stella P, Richel D, Szcylik C, Cascinu S, Frassineti GL, Ciuleanu T, Hurt K, Hynes S, Lin J, Lin AB, Von Hoff D, Calvo E. A phase II study to evaluate LY2603618 in combination with gemcitabine in pancreatic cancer patients. BMC Cancer. 2017 Feb 15;17(1):137. doi: 10.1186/s12885-017-3131-x.

Reference Type: DERIVED

PMID: 28202004 (View on PubMed)

Other Identifiers

I2I-MC-JMMC

Identifier Type: OTHER

Identifier Source: secondary_id

12096

Identifier Type: -

Identifier Source: org_study_id