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A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma

Primary Purpose

Pancreatic Ductal Adenocarcinoma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Abemaciclib

LY3023414

Gemcitabine

Capecitabine

About this trial

This is an interventional treatment trial for Pancreatic Ductal Adenocarcinoma focused on measuring pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histological or cytological diagnosis of ductal adenocarcinoma of the pancreas.
Metastatic disease with documented disease progression following previous treatment with at least one, but no more than 2 prior therapies, with one of the prior therapies having been either gemcitabine-based or fluoropyrimidine-based therapy. Neoadjuvant and/or adjuvant therapies for localized resectable or unresectable PDAC each count as a line of therapy if multiagent chemotherapy regimens were administered (and neoadjuvant regimen was different than adjuvant regimen) and if the participant progressed with metastatic disease while taking or within 6 months of completion of (neo)adjuvant therapy.
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Participant for whom treatment with monotherapy chemotherapy such as gemcitabine or capecitabine is a reasonable choice.
Discontinued all prior treatment for cancer at least 14 days prior to initial dose of study treatment.
Adequate organ function.
- allow alanine aminotransferase (ALT) or aspartate aminotransferase (AST) up to 5x upper limit of normal (ULN) if liver metastases.
- allow bilirubin up to 2.5 times ULN if elevation is not associated with other signs of liver toxicity or can be explained by mechanical obstruction - requires clinical research physician approval.

Exclusion Criteria:

Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: Participants with controlled atrial fibrillation for >30 days prior to study treatment initiation are eligible.
Have insulin-dependent diabetes mellitus. Participants with type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics as documented by hemoglobin A1c (HbA1c) <7%.
Have symptomatic central nervous system metastasis. Screening of asymptomatic participants is not required for enrollment.
Have had major surgery within 7 days prior to initiation of study drug to allow for postoperative healing of the surgical wound and site(s).
Have previously received treatment with any cyclin-dependent kinase (CDK) 4 and 6 inhibitor or phosphatidylinositol 3-kinase (PI3K) and/or mammalian target of rapamycin (mTOR) inhibitor or have a known hypersensitivity to any component of the investigational products in this study.
Have a known hypersensitivity to investigator's choice of standard of care (gemcitabine or capecitabine).

Sites / Locations

Yale University School of Medicine
Illinois CancerCare
Research Medical Center
Dartmouth Hitchcock Medical Center
University of Pittsburgh Medical Center
Sarah Cannon Cancer Center
Tennessee Oncology PLLC
Seattle Cancer Care Alliance
Virginia Mason Medical Center
University of Wisconsin-Madison Hospital and Health Clinic
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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.
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.
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.
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.
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Fundacion Jimenez Diaz
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Abemaciclib

Abemaciclib + LY3023414

Standard of Care (Gemcitabine or Capecitabine)

Arm Description

Abemaciclib given orally.

Abemaciclib given orally and LY3023414 given orally.

Gemcitabine given intravenously (IV) OR capecitabine given orally.

Outcomes

Primary Outcome Measures

Stage 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)

Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

Stage 2: Progression Free Survival (PFS)

PFS was defined as the time from the date of randomization until first observation of objective progressive disease as defined by RECIST v1.1 or death from any cause, whichever comes first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a patient does not have a complete baseline disease assessment, then the PFS time will be censored at the randomization date, regardless of whether or not objectively determined disease progression or death has been observed for the patient; otherwise, if a patient is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time will be censored at the last complete objective progression-free disease assessment date.

Secondary Outcome Measures

Stage 1: Objective Response Rate (ORR): Percentage of Participants With a Best Overall Response (BOR) of CR or PR

Objective response rate (ORR) is the percentage of participants with a BOR of CR or PR as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.

Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))

Mean steady state exposure was reported as measured by maximum observed plasma concentration (Cmax).

Stage 1: PK: Area Under the Curve (AUC) (AUC[Tau]) of LY3023414

Stage 1: PK: Maximum Concentration (Cmax) at Steady State of LY3023414

Stage 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD

Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months

Clinical benefit rate (CBR) is the percentage of participants with a BOR of CR or PR, or SD ≥6 months. CR is defined as the disappearance of all target and non-target lesions & no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.

Stage 2: Duration of Response (DoR)

Stage 2: Overall Survival (OS)

OS duration is measured from the date of randomization to the date of death from any cause. for participants who is not known to have died as of the data-inclusion cutoff date, OS was censored at the last known alive date. No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.

Stage 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level

No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.

Stage 2: Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)

mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, and enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours, and typical completion time for this instrument is less than 5 minutes. No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.

Stage 2: Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 items covered by 1 of 3 dimensions: Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent). Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much) Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much). Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden. No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.

Stage 1: PK: Steady State Trough Pre Dose Concentration of LY3023414

Mean steady state exposure was reported by trough pre-dose plasma concentrations.

Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose

Mean single dose exposure was reported by plasma concentrations collected approximately 2 hours post-dose.

Full Information

NCT ID

NCT02981342

First Posted

December 1, 2016

Last Updated

November 6, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02981342

Brief Title

A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma

Official Title

An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination With Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 18, 2019

Overall Recruitment Status

Completed

Study Start Date

January 12, 2017 (Actual)

Primary Completion Date

April 20, 2018 (Actual)

Study Completion Date

November 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in combination with other drugs versus standard of care in participants with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Ductal Adenocarcinoma

Keywords

pancreatic cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Abemaciclib

Arm Type

Experimental

Arm Description

Abemaciclib given orally.

Arm Title

Abemaciclib + LY3023414

Arm Type

Experimental

Arm Description

Abemaciclib given orally and LY3023414 given orally.

Arm Title

Standard of Care (Gemcitabine or Capecitabine)

Arm Type

Experimental

Arm Description

Gemcitabine given intravenously (IV) OR capecitabine given orally.

Intervention Type

Drug

Intervention Name(s)

Abemaciclib

Other Intervention Name(s)

LY2835219

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

LY3023414

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

LY188011

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

Stage 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)

Description

Time Frame

Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)

Title

Stage 2: Progression Free Survival (PFS)

Description

Time Frame

Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 6 Months)

Secondary Outcome Measure Information:

Title

Stage 1: Objective Response Rate (ORR): Percentage of Participants With a Best Overall Response (BOR) of CR or PR

Description

Time Frame

Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months)

Title

Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))

Description

Mean steady state exposure was reported as measured by maximum observed plasma concentration (Cmax).

Time Frame

Cycle(C)1 Day(D)14: 0 hour(h),0.5h,1h,2h,4h,6h,8h post dose

Title

Stage 1: PK: Area Under the Curve (AUC) (AUC[Tau]) of LY3023414

Time Frame

Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)

Title

Stage 1: PK: Maximum Concentration (Cmax) at Steady State of LY3023414

Time Frame

Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)

Title

Stage 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD

Time Frame

Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)

Title

Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months

Description

Time Frame

Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 6 Months)

Title

Stage 2: Duration of Response (DoR)

Time Frame

Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 6 Months)

Title

Stage 2: Overall Survival (OS)

Description

Time Frame

Baseline to Death from Any Cause (Up to 10 Months)

Title

Stage 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level

Description

No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.

Time Frame

Baseline, 6 Months

Title

Stage 2: Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)

Description

Time Frame

Baseline, 6 Months

Title

Stage 2: Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

Description

Time Frame

Baseline, 6 Months

Title

Stage 1: PK: Steady State Trough Pre Dose Concentration of LY3023414

Description

Mean steady state exposure was reported by trough pre-dose plasma concentrations.

Time Frame

C2D1: 0h, C3D1: 0h, C4D1: 0h

Title

Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose

Description

Mean single dose exposure was reported by plasma concentrations collected approximately 2 hours post-dose.

Time Frame

C1D1: 2h Post dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological or cytological diagnosis of ductal adenocarcinoma of the pancreas. Metastatic disease with documented disease progression following previous treatment with at least one, but no more than 2 prior therapies, with one of the prior therapies having been either gemcitabine-based or fluoropyrimidine-based therapy. Neoadjuvant and/or adjuvant therapies for localized resectable or unresectable PDAC each count as a line of therapy if multiagent chemotherapy regimens were administered (and neoadjuvant regimen was different than adjuvant regimen) and if the participant progressed with metastatic disease while taking or within 6 months of completion of (neo)adjuvant therapy. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Participant for whom treatment with monotherapy chemotherapy such as gemcitabine or capecitabine is a reasonable choice. Discontinued all prior treatment for cancer at least 14 days prior to initial dose of study treatment. Adequate organ function. allow alanine aminotransferase (ALT) or aspartate aminotransferase (AST) up to 5x upper limit of normal (ULN) if liver metastases. allow bilirubin up to 2.5 times ULN if elevation is not associated with other signs of liver toxicity or can be explained by mechanical obstruction - requires clinical research physician approval. Exclusion Criteria: Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: Participants with controlled atrial fibrillation for >30 days prior to study treatment initiation are eligible. Have insulin-dependent diabetes mellitus. Participants with type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics as documented by hemoglobin A1c (HbA1c) <7%. Have symptomatic central nervous system metastasis. Screening of asymptomatic participants is not required for enrollment. Have had major surgery within 7 days prior to initiation of study drug to allow for postoperative healing of the surgical wound and site(s). Have previously received treatment with any cyclin-dependent kinase (CDK) 4 and 6 inhibitor or phosphatidylinositol 3-kinase (PI3K) and/or mammalian target of rapamycin (mTOR) inhibitor or have a known hypersensitivity to any component of the investigational products in this study. Have a known hypersensitivity to investigator's choice of standard of care (gemcitabine or capecitabine).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Illinois CancerCare

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61615

Country

United States

Facility Name

Research Medical Center

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64132

Country

United States

Facility Name

Dartmouth Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756-0001

Country

United States

Facility Name

University of Pittsburgh Medical Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

Sarah Cannon Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Tennessee Oncology PLLC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Seattle Cancer Care Alliance

City

Olympia

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Virginia Mason Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

University of Wisconsin-Madison Hospital and Health Clinic

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792-4108

Country

United States

Facility Name

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

City

Blacktown

ZIP/Postal Code

2148

Country

Australia

Facility Name

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.

City

Sydney

ZIP/Postal Code

2010

Country

Australia

Facility Name

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

City

Lyon

ZIP/Postal Code

69373

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

City

Ramat Gan

ZIP/Postal Code

5262000

Country

Israel

Facility Name

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

City

Hospitalet de Llobregat

ZIP/Postal Code

08908

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Fundacion Jimenez Diaz

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

City

Taipei city

ZIP/Postal Code

10048

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

City

Taipei

Country

Taiwan

Facility Name

City

London

ZIP/Postal Code

NW1 2BU

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. More information provided by Eli Lilly and Company

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Links:

URL

https://www.lillytrialguide.com/en-US/studies/pancreatic-ductal-adenocarcinoma/JPCJ#?postal=

Description

A Study of Abemaciclib (LY2835219) Alone or in Combination with Other Agents in Participants with Previously Treated Pancreatic Ductal Adenocarcinoma

Learn more about this trial

A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma

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