Trial · NCT00839332

A Study for Participants With Pancreatic Cancer

NCT00839332, Phase 1, Phase 2, Completed, Eli Lilly and Company; results first posted 2018-04-17

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study for Participants With Pancreatic Cancer. Trials, record NCT00839332. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00839332

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study for Participants With Pancreatic Cancer
NCT number: NCT00839332
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 157 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Pancreatic Neoplasms
Interventions: LY2603618, Gemcitabine
First posted: 2009-02-09
Last updated: 2018-04-17
Results first posted: 2018-04-17

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Phase 1: Determine the Recommended Phase 2 Dose for LY2603618 When Administered After Gemcitabine	Baseline through 18 months	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 \[ng/mL\]).
Primary	Phase 2: Overall Survival (OS)	Phase 2: Baseline to date of death	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.
Secondary	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.	Plasma samples for pharmacokinetic (PK) analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine and dFdU plasma concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only the LY2603618 plasma Cmax values are reported for each LY2603618 dose level on Cycle (C) 1 /Day (D) 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each dose level and time point.
Secondary	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.	Plasma samples for PK analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine and dFdU plasma concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only the LY2603618 plasma Cmax values are reported at the 230 mg LY2603618 dose level on Cycle 1 /Day 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each time point.
Secondary	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.	Plasma samples for PK analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine plasma and dFdU concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only LY2603618 plasma AUC from time zero to 24 hours (AUC\[0-24\]), AUC from time zero to the last time point with a measurable concentration (AUC\[0-tlast\]), and AUC from time zero to infinity (AUC\[0-inf\]) values are reported for each LY2603618 dose level on Cycle 1 /Day 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each dose level and time point.
Secondary	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.	Plasma samples for PK analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine and dFdU plasma concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only the LY2603618 plasma AUC(0-24), AUC(0-tlast), and AUC(0-inf) values are reported for the 230 mg LY2603618 dose on Cycle 1 /Day 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each time point.
Secondary	Phase 2: Progression-free Survival (PFS)	Phase 2: Baseline to measured progressive disease or date of death from any cause	Progression-free survival (PFS) time was defined as the time from the date of randomization to the first date of progressive disease (symptomatic or objective) or death due to any cause, whichever occurred first. For participants who were not known to have died or progressed as of the data-inclusion cutoff date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy. PFS was summarized using Kaplan-Meier estimates.
Secondary	Phase 2: Overall Response Rate	Phase 2: Baseline to measured progressive disease or date of death from any cause	Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
Secondary	Phase 2: Clinical Benefit Rate	Phase 2: Baseline to measured progressive disease or date of death from any cause	Clinical benefit rate is the best response CR, PR, or stable disease (SD) as classified by the investigators according to the RECIST v1.1 guidelines. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Overall response rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
Secondary	Phase 2: Duration of Response	Phase 2. Baseline to measured progressive disease or date of death from any cause	Duration of response was defined as the time from the first observation of complete response (CR) or partial response (PR) to the first observation of progressive disease or death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date and who do not have progressive disease, the duration was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent anticancer therapy (systemic, radiologic, or surgery). Participants were also censored at the last valid assessment prior to missing more than 1 consecutive scheduled assessment. Duration of response was summarized using Kaplan-Meier estimates.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Phase 1: Determine the Recommended Phase 2 Dose for LY2603618 When Administered After Gemcitabine	Baseline through 18 months	Phase 1 participants who received at least 1 dose of study drug.	milligrams (mg)	NUMBER
PRIMARY	Phase 2: Overall Survival (OS)	Phase 2: Baseline to date of death	Phase 2 participants who were randomized.	months	MEDIAN
SECONDARY	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 1 participants who received at least 1 dose of study drug (LY2603618) and had sufficient LY2603618 plasma concentration data to enable determination of the LY2603618 Cmax.	nanograms per milliliter (ng/mL)	GEOMETRIC_MEAN
SECONDARY	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 2 participants who received at least 1 dose of study drug (LY2603618) and had sufficient LY2603618 plasma concentration data to enable determination of the LY2603618 Cmax.	ng/mL	GEOMETRIC_MEAN
SECONDARY	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 1 participants who received at least 1 dose of study drug (LY2603618) and had sufficient LY2603618 plasma concentration data to enable calculation of the LY2603618 AUC.	nanogramhour/milliliter (ngh/mL)	GEOMETRIC_MEAN
SECONDARY	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 participants who received at least 1 dose of study drug (LY2603618) and had sufficient LY2603618 plasma concentration data to enable calculation of the LY2603618 AUC.	ng*h/mL	GEOMETRIC_MEAN
SECONDARY	Phase 2: Progression-free Survival (PFS)	Phase 2: Baseline to measured progressive disease or date of death from any cause	Phase 2 participants who were randomized.	months	MEDIAN
SECONDARY	Phase 2: Overall Response Rate	Phase 2: Baseline to measured progressive disease or date of death from any cause	Phase 2 participants who were randomized.	percentage of participants	NUMBER
SECONDARY	Phase 2: Clinical Benefit Rate	Phase 2: Baseline to measured progressive disease or date of death from any cause	Phase 2 participants who were randomized.	percentage of participants	NUMBER
OTHER_PRE_SPECIFIED	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	Participants enrolled in Phase 1.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group137

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Phase 1: Determine the Recommended Phase 2 Dose for LY2603618 When Administered After Gemcitabine	Phase 1: LY2603618 + Gemcitabine		230		milligrams (mg)
Phase 2: Overall Survival (OS)	Phase 2: LY2603618 + Gemcitabine		7.8	95% Confidence Interval 5.0 to 11.1	months
Phase 2: Overall Survival (OS)	Phase 2: Gemcitabine		8.3	95% Confidence Interval 5.1 to 14.1	months
Phase 1: Maximum Plasma Concentration (Cmax) of Gemcitabine, 2',2'-Difluorodeoxyuridine (dFdU), and LY2603618	Phase 1: LY2603618 + Gemcitabine	70 mg/m^2, Cycle 1 /Day 2	3530	Geometric Coefficient of Variation 23	nanograms per milliliter (ng/mL)
Phase 1: Maximum Plasma Concentration (Cmax) of Gemcitabine, 2',2'-Difluorodeoxyuridine (dFdU), and LY2603618	Phase 1: LY2603618 + Gemcitabine	70 mg/m^2, Cycle 1 /Day 16	3360	Geometric Coefficient of Variation 26	nanograms per milliliter (ng/mL)
Phase 1: Maximum Plasma Concentration (Cmax) of Gemcitabine, 2',2'-Difluorodeoxyuridine (dFdU), and LY2603618	Phase 1: LY2603618 + Gemcitabine	70 mg/m^2, Cycle 2 /Day 2	3100	Geometric Coefficient of Variation 12	nanograms per milliliter (ng/mL)
Phase 1: Maximum Plasma Concentration (Cmax) of Gemcitabine, 2',2'-Difluorodeoxyuridine (dFdU), and LY2603618	Phase 1: LY2603618 + Gemcitabine	105 mg/m^2, Cycle 1 /Day 2	4890	Geometric Coefficient of Variation 25	nanograms per milliliter (ng/mL)
Phase 1: Maximum Plasma Concentration (Cmax) of Gemcitabine, 2',2'-Difluorodeoxyuridine (dFdU), and LY2603618	Phase 1: LY2603618 + Gemcitabine	105 mg/m^2, Cycle 1 /Day 16	5170	Geometric Coefficient of Variation 38	nanograms per milliliter (ng/mL)
Phase 1: Maximum Plasma Concentration (Cmax) of Gemcitabine, 2',2'-Difluorodeoxyuridine (dFdU), and LY2603618	Phase 1: LY2603618 + Gemcitabine	105 mg/m^2, Cycle 2 /Day 2	5360	Geometric Coefficient of Variation 23	nanograms per milliliter (ng/mL)
Phase 1: Maximum Plasma Concentration (Cmax) of Gemcitabine, 2',2'-Difluorodeoxyuridine (dFdU), and LY2603618	Phase 1: LY2603618 + Gemcitabine	150 mg/m^2, Cycle 1 /Day 2	4280	Geometric Coefficient of Variation 29	nanograms per milliliter (ng/mL)

1 to 10 of 137Source ClinicalTrials.gov

See all 137 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Phase 1	STARTED	Phase 1: LY2603618 + Gemcitabine	50
Phase 1	STARTED	Phase 2: LY2603618 + Gemcitabine	0
Phase 1	STARTED	Phase 2: Gemcitabine	0
Phase 1	Received at Least 1 Dose of Study Drug	Phase 1: LY2603618 + Gemcitabine	50
Phase 1	Received at Least 1 Dose of Study Drug	Phase 2: LY2603618 + Gemcitabine	0
Phase 1	Received at Least 1 Dose of Study Drug	Phase 2: Gemcitabine	0
Phase 1	COMPLETED	Phase 1: LY2603618 + Gemcitabine	0
Phase 1	COMPLETED	Phase 2: LY2603618 + Gemcitabine	0
Phase 1	COMPLETED	Phase 2: Gemcitabine	0
Phase 1	NOT COMPLETED	Phase 1: LY2603618 + Gemcitabine	50

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events510

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Phase 1: LY2603618 + Gemcitabine	23	50	29
other	Anaemia	Blood and lymphatic system disorders	Phase 2: LY2603618 + Gemcitabine	16	65	21
other	Anaemia	Blood and lymphatic system disorders	Phase 2: Gemcitabine	10	34	13
other	Leukocytosis	Blood and lymphatic system disorders	Phase 1: LY2603618 + Gemcitabine	3	50	3
other	Leukocytosis	Blood and lymphatic system disorders	Phase 2: LY2603618 + Gemcitabine	1	65	1
other	Leukocytosis	Blood and lymphatic system disorders	Phase 2: Gemcitabine	0	34	0
other	Leukopenia	Blood and lymphatic system disorders	Phase 1: LY2603618 + Gemcitabine	4	50	5
other	Leukopenia	Blood and lymphatic system disorders	Phase 2: LY2603618 + Gemcitabine	8	65	27
other	Leukopenia	Blood and lymphatic system disorders	Phase 2: Gemcitabine	6	34	10
other	Lymphopenia	Blood and lymphatic system disorders	Phase 1: LY2603618 + Gemcitabine	5	50	6

1 to 10 of 510Source ClinicalTrials.gov

See all 510 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase 1: LY2603618 + Gemcitabine
Total, all-cause mortality	Phase 2: LY2603618 + Gemcitabine
Total, all-cause mortality	Phase 2: Gemcitabine
Total, other adverse events	Phase 1: LY2603618 + Gemcitabine	48	50
Total, other adverse events	Phase 2: LY2603618 + Gemcitabine	64	65
Total, other adverse events	Phase 2: Gemcitabine	34	34
Total, serious adverse events	Phase 1: LY2603618 + Gemcitabine	21	50
Total, serious adverse events	Phase 2: LY2603618 + Gemcitabine	27	65
Total, serious adverse events	Phase 2: Gemcitabine	18	34

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28202004	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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