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Phase I/II Study of LY2090314 and Chemotherapy in Metastatic Pancreatic Cancer Patients With Metastases Amenable to Biopsy


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

Phase I/II Study of LY2090314 and Chemotherapy in Metastatic Pancreatic Cancer Patients With Metastases Amenable to Biopsy


Inclusion Criteria:



- Metastatic pancreatic cancer with metastases amenable to biopsy

- Willingness to provide tissue and blood samples for research purposes

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

Exclusion Criteria:

- History of islet cell, acinar cell, or cystadenocarcinomas

- Prior cytotoxic chemotherapy for metastatic disease, except prior gemcitabine or
FOLFIRINOX (5FU + leucovorin + irinotecan + oxaliplatin)

- Radiation therapy, immunotherapy or biologic therapy <28 days prior to study entry

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change from Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation

Outcome Time Frame:

Baseline, 4 Hours Post-Treatment on Day 0

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

14453

NCT ID:

NCT01632306

Start Date:

March 2013

Completion Date:

May 2017

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location
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  32256
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. Minneapolis, Minnesota  55404