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A Study for Participants With Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00839332
Recruitment Status : Completed
First Posted : February 9, 2009
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pancreatic Neoplasms
Interventions: Drug: LY2603618
Drug: Gemcitabine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Phase 1: LY2603618 + Gemcitabine

All participants in Phase 1 received LY2603618 in combination with gemcitabine.

LY2603618: 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. Participants received LY2603618 as part of the dose escalation cohort of Phase 1 (dose of 70, 105, 150, 200, or 250 mg/m^2) or as part of the expansion cohort of Phase 1 (flat dose of 200 or 230 mg). The flat dose cohorts were conducted in parallel.

Gemcitabine: 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. Participants received gemcitabine 24 hours prior to LY2603618 administration.

Phase 2: LY2603618 + Gemcitabine

LY2603618: 230 mg flat dose 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 disease progression.

Gemcitabine: Participants were administered 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. Participants received gemcitabine 24 hours prior to LY2603618 administration.

Phase 2: Gemcitabine Gemcitabine: 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.

Participant Flow for 2 periods

Period 1:   Phase 1
    Phase 1: LY2603618 + Gemcitabine   Phase 2: LY2603618 + Gemcitabine   Phase 2: Gemcitabine
STARTED   50   0 [1]   0 [1] 
Received at Least 1 Dose of Study Drug   50   0   0 
COMPLETED   0   0   0 
NOT COMPLETED   50   0   0 
Disease Progression                38                0                0 
Adverse Event                6                0                0 
Withdrawal by Subject                4                0                0 
Physician Decision                2                0                0 
[1] Participants in Phase 2 did not participate in Phase 1.

Period 2:   Phase 2
    Phase 1: LY2603618 + Gemcitabine   Phase 2: LY2603618 + Gemcitabine   Phase 2: Gemcitabine
STARTED   0 [1]   68   39 
Received at Least 1 Dose of Study Drug   0   65   34 
COMPLETED   0   0   0 
NOT COMPLETED   0   68   39 
Protocol Violation                0                1                0 
Disease Progression                0                46                21 
Adverse Event                0                8                6 
Death                0                4                2 
Withdrawal by Subject                0                5                8 
Physician Decision                0                4                1 
Lost to Follow-up                0                0                1 
[1] Participants in Phase 1 did not participate in Phase 2.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Phase 1: LY2603618 + Gemcitabine

All participants in Phase 1 received LY2603618 in combination with gemcitabine.

LY2603618: 70 to 250 mg/m^2 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 disease progression. Participants received LY2603618 as part of the dose escalation cohort of Phase 1 (dose of 70, 105, 150, 200, or 250 mg/m^2) or as part of the expansion cohort of Phase 1 (flat dose of 200 or 230 mg). The flat dose cohorts were conducted in parallel.

Gemcitabine: 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. Participants received gemcitabine 24 hours prior to LY2603618 administration.

Phase 2: LY2603618 + Gemcitabine

LY2603618: 230 mg flat dose 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 disease progression.

Gemcitabine: Participants were administered 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. Participants received gemcitabine 24 hours prior to LY2603618 administration.

Phase 2: Gemcitabine Gemcitabine: 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.
Total Total of all reporting groups

Baseline Measures
   Phase 1: LY2603618 + Gemcitabine   Phase 2: LY2603618 + Gemcitabine   Phase 2: Gemcitabine   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   65   34   149 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.0  (12.2)   64.3  (8.3)   64.4  (10.1)   62.54  (11.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female   24   23   14   61 
Male   26   42   20   88 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
White   46   62   32   140 
Black or African American   1   2   2   5 
American Indian or Alaska Native   0   1   0   1 
Asian   3   0   0   3 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   32   27   14   73 
Spain   18   12   5   35 
Romania   0   2   1   3 
Germany   0   17   9   26 
Netherlands   0   3   2   5 
Italy   0   3   2   5 
Poland   0   1   1   2 
Initial Pathological Diagnosis 
[Units: Participants]
Count of Participants
       
Adenocarcinoma, Pancreas   10   65   34   109 
Adenocarcinoma, Colon   7   0   0   7 
Carcinoma, Breast   4   0   0   4 
Carcinoma, Non-Small Cell, Lung NOS   3   0   0   3 
Adenocarcinoma, Cervix   2   0   0   2 
Adenocarcinoma, Rectum   2   0   0   2 
Carcinoma, Endometrium   2   0   0   2 
Carcinoma, Infiltrating Ductal, Breast   2   0   0   2 
Carcinoma, Renal Cell   2   0   0   2 
Sarcoma, Leiomyosarcoma, Abdomen (Non-Gist)   2   0   0   2 
Squamous Cell Carcinoma, Head and Neck   2   0   0   2 
Ampulla of Pancreas   1   0   0   1 
Carcinoma, Head and Neck   1   0   0   1 
Carcinoma, Ovarian   1   0   0   1 
Carcinoma, Peritoneal   1   0   0   1 
Carcinoma, Small Cell, Lung   1   0   0   1 
Carcinoma, Transitional Cell, Urothelium   1   0   0   1 
Ewing's Sarcoma   1   0   0   1 
Lymphoma, Non-Hodgkin's Lymphoma   1   0   0   1 
Mesothelioma, Pleural, Malignant   1   0   0   1 
Ovarian Adenocarcinoma   1   0   0   1 
Squamous Cell Carcinoma, Cervix   1   0   0   1 
Tumor   1   0   0   1 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
Count of Participants
       
ECOG Status 0   19   28   14   61 
ECOG Status 1   31   31   17   79 
ECOG Status 2   0   6   3   9 
[1] Eastern Cooperative Oncology Group (ECOG) Performance Status classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death) as follows: 0 - Fully Active; 1 - Ambulatory, Restricted Strenuous Activity; 2 - Ambulatory, No Work Activities; 3 - Partially Confined to Bed, Limited Self Care; 4 - Completely Disabled; and 5 - Dead.


  Outcome Measures

1.  Primary:   Phase 1: Determine the Recommended Phase 2 Dose for LY2603618 When Administered After Gemcitabine   [ Time Frame: Baseline through 18 months ]

2.  Primary:   Phase 2: Overall Survival (OS)   [ Time Frame: Phase 2: Baseline to date of death ]

3.  Secondary:   Phase 1: Maximum Plasma Concentration (Cmax) of Gemcitabine, 2',2'-Difluorodeoxyuridine (dFdU), and LY2603618   [ Time Frame: 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. ]

4.  Secondary:   Phase 2: Maximum Plasma Concentration (Cmax) of Gemcitabine, dFdU, and LY2603618   [ Time Frame: 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. ]

5.  Secondary:   Phase 1: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618   [ Time Frame: 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. ]

6.  Secondary:   Phase 2: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618   [ Time Frame: 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. ]

7.  Secondary:   Phase 2: Progression-free Survival (PFS)   [ Time Frame: Phase 2: Baseline to measured progressive disease or date of death from any cause ]

8.  Secondary:   Phase 2: Overall Response Rate   [ Time Frame: Phase 2: Baseline to measured progressive disease or date of death from any cause ]

9.  Secondary:   Phase 2: Clinical Benefit Rate   [ Time Frame: Phase 2: Baseline to measured progressive disease or date of death from any cause ]

10.  Secondary:   Phase 2: Duration of Response   [ Time Frame: Phase 2. Baseline to measured progressive disease or date of death from any cause ]

11.  Secondary:   Phase 1: Electrocardiogram QTc Prolongation   [ Time Frame: Phase 1: Days 2 and 16 of Cycle 1 ]

12.  Secondary:   Phase 2: Electrocardiogram QTc Prolongation   [ Time Frame: Phase 2: Days 2 and 16 of Cycle 1 ]

13.  Other Pre-specified:   Number of Deaths During the Phase 1 Post-study Period   [ Time Frame: Phase 1: Time of last dose of study drug through the end of the follow-up period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00839332     History of Changes
Other Study ID Numbers: 12096
I2I-MC-JMMC ( Other Identifier: Eli Lilly and Company )
First Submitted: February 6, 2009
First Posted: February 9, 2009
Results First Submitted: February 17, 2018
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018