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

Lilly

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Pancreatic Cancer

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01632306

I2H-MC-JWYD (Other Identifier)

14453

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 3 patient groups

LY2090314 + Gemcitabine

Experimental group

Description:

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.

Treatment:

Drug: Gemcitabine

Drug: LY2090314

LY2090314 + FOLFOX

Experimental group

Description:

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.

Treatment:

Drug: LY2090314

Drug: FOLFOX

LY2090314 + Gemcitabine + Nab-paclitaxel

Experimental group

Description:

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.

Treatment:

Drug: Nab-paclitaxel

Drug: Gemcitabine

Drug: LY2090314