A Study of LY2090314 and Chemotherapy in Participants With Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01632306
• Other study ID #: 14453
• Secondary ID: I2H-MC-JWYD
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: March 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose of this phase I/II study is to test how well LY2090314 works in combination with different chemotherapies in treating participants with metastatic pancreatic cancer.

Other known NCT identifiers

• NCT01671202

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• LY2090314
LY2090314 administered IV
• FOLFOX
FOLFOX administered IV
• Gemcitabine
Gemcitabine administered IV
• Nab-paclitaxel
Nab-paclitaxel administered IV

Locations

Country	Name	City	State
United States	Mayo Clinic of Jacksonville	Jacksonville	Florida
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation	Change in the phosphorylation level of glycogen synthase, a glycogen synthase kinase-3 beta (GSK-3beta) inhibitor, from baseline to 4 hours post-treatment on day 0 using tumor tissue and blood specimens.	Baseline, 4 Hours Post-Treatment on Day 0
Secondary	Overall Survival (OS)		Baseline to Date of Death Due to any Cause Up to 21 Months
Secondary	Percentage of Participants Who Survived at 6 Months		Baseline to Date of Death to any cause Up to 6 Months
Secondary	Progression Free Survival (PFS)	PFS was as the time from enrollment to the earliest documented evidence of disease progression or death,whatever comes first.	Baseline to Disease Progression Up to 18 Months
Secondary	Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]	Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.; A CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.	Baseline Up to 6 Months