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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

157

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Feb 2009

Longer than P75 for phase_1

Geographic Reach

6 countries

30 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.8 years study duration

Study Start

First participant enrolled

February 1, 2009

Completed

5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed

4.4 years until next milestone

Results Posted

Study results publicly available

April 17, 2018

Completed

Last Updated

April 17, 2018

Status Verified

March 1, 2018

Enrollment Period

4 years

First QC Date

February 6, 2009

Results QC Date

February 17, 2018

Last Update Submit

March 15, 2018

Conditions

Pancreatic Neoplasms

Keywords

Pancreasmetastatic canceradvanced cancerPancreatic cancer

Outcome Measures

Primary Outcomes (2)

Phase 1: Determine the Recommended Phase 2 Dose for LY2603618 When Administered After Gemcitabine
The recommended Phase 2 dose for LY2603618 when administered approximately 24 hours after gemcitabine was based on the maximum tolerated dose and achievement of predefined LY2603618 plasma systemic exposures targets (area under the LY2603618 plasma concentration versus time curve from time zero to infinity \[AUC(0-inf)\] \>21,000 nanogram\*hour/milliliter \[ng\*h/mL\] and maximum LY2603618 plasma concentration \[Cmax\] \>2000 nanograms/milliliter \[ng/mL\]).
Baseline through 18 months
Phase 2: Overall Survival (OS)
Overall survival (OS) time is defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the cut-off date. OS was summarized using Kaplan-Meier estimates.
Phase 2: Baseline to date of death

Secondary Outcomes (10)

Phase 1: Maximum Plasma Concentration (Cmax) of Gemcitabine, 2',2'-Difluorodeoxyuridine (dFdU), and LY2603618
Phase 1: LY2603618 - Predose and 0, 1, 3, 6, 24, 48, and 72 hours after the end of infusion on C1 /D2, C1 /D16, and C2 /D2. Gemcitabine - Predose and 0, 10, 30, 60, and 120 minutes after the end of infusion on C1 /D1, C1 /D15, and C2 /D1.
Phase 2: Maximum Plasma Concentration (Cmax) of Gemcitabine, dFdU, and LY2603618
Phase 2: LY2603618 - Predose and 0, 1, 3, and 24 hours after the end of infusion on Days 2 and 16 of Cycle 1. Gemcitabine - Predose and 0, 10, 60, and 120 minutes after the end of infusion on Days 1 and 15 of Cycle 1.
Phase 1: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618
Phase 1: LY2603618 - Predose and 0, 1, 3, 6, 24, 48, and 72 hours after the end of infusion on C1 /D2, C1 /D16, and C2 /D2. Gemcitabine - Predose and 0, 10, 30, 60, and 120 minutes after the end of infusion on C1 /D1, C1 /D15, and C2 /D1.
Phase 2: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618
Phase 2: LY2603618 - Predose and 0, 1, 3, and 24 hours after the end of infusion on Days 2 and 16 of Cycle 1. Gemcitabine - Predose and 0, 10, 60, and 120 minutes after the end of infusion on Days 1 and 15 of Cycle 1.
Phase 2: Progression-free Survival (PFS)
Phase 2: Baseline to measured progressive disease or date of death from any cause
+5 more secondary outcomes

Other Outcomes (1)

Number of Deaths During the Phase 1 Post-study Period
Phase 1: Time of last dose of study drug through the end of the follow-up period

Study Arms (2)

LY2603618 + Gemcitabine

EXPERIMENTAL

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.

Drug: LY2603618Drug: Gemcitabine

Gemcitabine

ACTIVE COMPARATOR

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.

Drug: Gemcitabine

Interventions

LY2603618DRUG

LY2603618 + Gemcitabine

GemcitabineDRUG

Also known as: Gemzar, LY188011

GemcitabineLY2603618 + Gemcitabine

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (30)

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, 32224, United States

Location

Athens, Georgia, 30607, United States

Location

Macon, Georgia, 31201, United States

Location

Post Falls, Idaho, 83854, United States

Location

Sioux City, Iowa, 51101, United States

Location

Ann Arbor, Michigan, 48106, United States

Location

Rochester, Minnesota, 55905, United States

Location

Fargo, North Dakota, 58122, United States

Location

Danville, Pennsylvania, 17822, United States

Location

Sioux Falls, South Dakota, 57104, United States

Location

Memphis, Tennessee, 38119, United States

Location

San Antonio, Texas, 78217, United States

Location

The Woodlands, Texas, 77380, United States

Location

Tyler, Texas, 75702, United States

Location

Hampton, Virginia, 23666, United States

Location

Green Bay, Wisconsin, 54307, United States

Location

Berlin, 13353, Germany

Location

Frankfurt, 60596, Germany

Location

Freiburg im Breisgau, D-79106, Germany

Location

Hamburg, 20246, Germany

Location

Heilbronn, 74078, Germany

Location

Nuremberg, 90419, Germany

Location

Ancona, 60126, Italy

Location

Florence, 50139, Italy

Location

Mendola, 47014, Italy

Location

Amsterdam, 1105 AZ, Netherlands

Location

Bucharest, Romania

Location

Cluj-Napoca, 400015, Romania

Location

L'Hospitalet de Llobregat, 08908, Spain

Location

Madrid, 28050, Spain

Location

Related Publications (1)

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.
PMID: 28202004DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsNeoplasm Metastasis

Interventions

LY2603618Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 9, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2013

Study Completion

December 1, 2013

Last Updated

April 17, 2018

Results First Posted

April 17, 2018

Record last verified: 2018-03

Locations

RO(2)DE(6)ES(2)IT(3)NL(1)US(16)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Other Outcomes (1)

Study Arms (2)

LY2603618 + Gemcitabine

Gemcitabine

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (30)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations