A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial in participants with locally advanced/inoperable or metastatic pancreatic cancer, and will investigate 2 different doses of LY2495655 in combination with standard of care chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion:

• Unresectable or metastatic pancreas cancer; participants with previous radical surgery for pancreas cancer are eligible after progression is documented

• Participants may have received previous adjuvant treatment with gemcitabine with or without radiotherapy for pancreas cancer

• ECOG (Eastern Cooperative Oncology Group) Performance status ≤ 2

• Adequate organ function

• Have an estimated life expectancy of at least 12 weeks and in the judgment of the investigator, will be able to complete at least 2 cycles of treatment

• Ability to perform the indicated functional performance measures at baseline

Exclusion:

• Prior systemic therapy for unresectable/metastatic pancreas cancer

• Any medical or psychiatric condition, orthopedic or neuromuscular conditions that could limit participation or confound study results

• Currently taking medications that are considered both muscle building and performance enhancing (for example, androgen therapies, or anabolic steroids)