A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Placebo; Drug: LY2495655; Drug: Standard of Care Chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01505530

I1Q-MC-JDDG (Other Identifier)

12552

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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125 participants in 3 patient groups, including a placebo group

300 mg LY2495655 + chemotherapy

Experimental group

Description:

300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)

Treatment:

Drug: Standard of Care Chemotherapy

Drug: LY2495655

100 mg LY2495655 + chemotherapy

Experimental group

Description:

100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)

Treatment:

Drug: Standard of Care Chemotherapy

Drug: LY2495655

Placebo + chemotherapy

Placebo Comparator group

Description:

Placebo in combination with standard of care chemotherapy (investigator's choice)

Treatment:

Drug: Standard of Care Chemotherapy

Drug: Placebo