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

NCT01632306 | Terminated Phase 1 Results

• 2 other identifiers: 14453I2H-MC-JWYD
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall Survival (OS)

  Baseline to Date of Death Due to any Cause Up to 21 Months

• Percentage of Participants Who Survived at 6 Months

  Baseline to Date of Death to any cause Up to 6 Months

• Progression Free Survival (PFS)

  Baseline to Disease Progression Up to 18 Months

• Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]

  Baseline Up to 6 Months

Study Arms (3)

LY2090314 + Gemcitabine

EXPERIMENTAL

LY2090314 given intravenously (IV) on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 milligram/square meter (mg/m\^2) gemcitabine given IV on days 1, 8 and 15. Cohort closed to new enrollment per protocol addendum.

Drug: LY2090314; Drug: Gemcitabine

LY2090314 + FOLFOX

EXPERIMENTAL

LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), and 15 in 28 day cycle in combination with FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) given IV, on days 1 and 15 in 28 day cycle.

Drug: LY2090314; Drug: FOLFOX

LY2090314 + Gemcitabine + Nab-paclitaxel

EXPERIMENTAL

LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 mg/m\^2 gemcitabine + 125 mg/m\^2 nab-paclitaxel given IV on days 1, 8 and 15 in 28-day cycle. New cohort opened per protocol amendment.

Drug: LY2090314; Drug: Gemcitabine; Drug: Nab-paclitaxel

Interventions

LY2090314 DRUG

LY2090314 administered IV

LY2090314 + FOLFOX; LY2090314 + Gemcitabine; LY2090314 + Gemcitabine + Nab-paclitaxel

FOLFOX DRUG

FOLFOX administered IV

Also known as: FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin)

LY2090314 + FOLFOX

Gemcitabine DRUG

Gemcitabine administered IV

Also known as: Gemzar, LY188011

LY2090314 + Gemcitabine; LY2090314 + Gemcitabine + Nab-paclitaxel

Nab-paclitaxel DRUG

Nab-paclitaxel administered IV

LY2090314 + Gemcitabine + Nab-paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Mayo Clinic: collaborator

Study Sites (2)

Mayo Clinic of Jacksonville

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

3-(9-fluoro-2-(piperidin-1-ylcarbonyl)-1,2,3,4-tetrahydro(1,4)diazepino(6,7,1-hi)indol-7-yl)-4-imidazo(1,2-a)pyridin-3-yl-1H-pyrrole-2,5-dione; Folfox protocol; Leucovorin; Fluorouracil; Oxaliplatin; Gemcitabine; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides

Limitations and Caveats

Study was terminated due to slow enrollment. No participants were enrolled in arm LY2090314 + Gemcitabine + Nab-paclitaxel due to inability to enroll participants.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 2, 2012
• Study Start: March 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 15, 2019
• Results First Posted: November 19, 2018

Record last verified: 2019-01

Locations

US (2)