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

NCT ID: NCT01632306

Last Updated: 2019-01-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LY2090314 + Gemcitabine

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.

Group Type EXPERIMENTAL

LY2090314

Intervention Type DRUG

LY2090314 administered IV

Gemcitabine

Intervention Type DRUG

Gemcitabine administered IV

LY2090314 + FOLFOX

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.

Group Type EXPERIMENTAL

LY2090314

Intervention Type DRUG

LY2090314 administered IV

FOLFOX

Intervention Type DRUG

FOLFOX administered IV

LY2090314 + Gemcitabine + Nab-paclitaxel

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.

Group Type EXPERIMENTAL

LY2090314

Intervention Type DRUG

LY2090314 administered IV

Gemcitabine

Intervention Type DRUG

Gemcitabine administered IV

Nab-paclitaxel

Intervention Type DRUG

Nab-paclitaxel administered IV

Interventions

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LY2090314

LY2090314 administered IV

Intervention Type DRUG

FOLFOX

FOLFOX administered IV

Intervention Type DRUG

Gemcitabine

Gemcitabine administered IV

Intervention Type DRUG

Nab-paclitaxel

Nab-paclitaxel administered IV

Intervention Type DRUG

Other Intervention Names

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FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) Gemzar LY188011

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Mayo Clinic of Jacksonville

Jacksonville, Florida, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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I2H-MC-JWYD

Identifier Type: OTHER

Identifier Source: secondary_id

14453

Identifier Type: -

Identifier Source: org_study_id

NCT01671202

Identifier Type: -

Identifier Source: nct_alias

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