Clinical Trial Details

NCT ID: NCT02981342
Date Last Changed: October 3, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study for the treatment of Pancreatic Ductal Adenocarcinoma

Research Study 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

Purpose

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).

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Eli Lilly and Company
Duration
23 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

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).

Site Locations (20)

Country State City Zip Facility and Contact
United States California Palo Alto 94305 Stanford Univ Medical Center
650-725-9057

George Fisher
Principal Investigator
United States Illinois Peoria 61615 Illinois CancerCare
309-243-3000

Madhuri Bajaj
Principal Investigator
United States New Hampshire Lebanon 03756-0001 Dartmouth Hitchcock Medical Center
603-650-8162

Kathryn Hourdequin
Principal Investigator
United States Pennsylvania Pittsburgh 15232 University of Pittsburgh Medical Center
412-864-7764

Nathan Bahary
Principal Investigator
United States Washington Olympia 98109 Seattle Cancer Care Alliance
206-288-6248

Gabriela Chiorean
Principal Investigator
United States Washington Seattle 98101 Virginia Mason Medical Center
206-223-6600

Vincent Picozzi
Principal Investigator
United States Wisconsin Madison 53792-4108 University of Wisconsin-Madison Hospital and Health Clinic
608-263-7502

Sam Lubner
Principal Investigator
Australia Blacktown 2148 Blacktown Hospital
Eli Lilly and Company
Belgium Brussels 1200 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.
Eli Lilly and Company
Belgium Edegem 2650 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.
Eli Lilly and Company
Belgium Wilrijk 2610 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.
Eli Lilly and Company
France Pessac 33604 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.
Eli Lilly and Company
Israel Ramat Gan 52621 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.
Eli Lilly and Company
Spain Barcelona 08036 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.
Eli Lilly and Company
Spain Hospitalet de Llobregat 08908 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.
Eli Lilly and Company
Spain Madrid 28040 Fundacion Jimenez Diaz
91 550 48 00

Manuel Dómine Gómez
Principal Investigator
Spain Malaga 29010 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.
Eli Lilly and Company
Taiwan Taipei 10048 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.
Eli Lilly and Company
United Kingdom Acton W12 0HS 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.
Eli Lilly and Company
United Kingdom London NW1 2BU 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.
Eli Lilly and Company

Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559

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