Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS)
Overall survival (OS) duration was measured from the date of randomization to the date of death from any cause.
Baseline to Death from Any Cause (Up to 23 months)

Secondary Outcomes (11)

Progression Free Survival (PFS)
Baseline to Disease Progression or Death from Any Cause (Up to 16 months)
Percentage of Participants With Tumor Response Rate (RR)
Baseline to Disease Progression (Up to 11 months)
Duration of Response
First CR or PR to Disease Progression (Up to 11 months)
Change in Lean Body Mass
Baseline, Cycles 3, 5, 7, 9 and 11; Day 1
Change in Physical Performance Measures Using Hand Grip Strength
Baseline, Cycles 2, 4, 6, 8 and 10; Day 1
+6 more secondary outcomes

Study Arms (3)

300 mg LY2495655 + chemotherapy

EXPERIMENTAL

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

Drug: LY2495655Drug: Standard of Care Chemotherapy

100 mg LY2495655 + chemotherapy

EXPERIMENTAL

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

Drug: LY2495655Drug: Standard of Care Chemotherapy

Placebo + chemotherapy

PLACEBO COMPARATOR

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

Drug: PlaceboDrug: Standard of Care Chemotherapy

Interventions

LY2495655DRUG

Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.

100 mg LY2495655 + chemotherapy300 mg LY2495655 + chemotherapy

PlaceboDRUG

Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.

Placebo + chemotherapy

Standard of Care ChemotherapyDRUG

Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regimen or FOLFIRINOX will be determined by the investigator (based on the standard of care used at the treating institution or as directed by local regulatory authorities).

100 mg LY2495655 + chemotherapy300 mg LY2495655 + chemotherapyPlacebo + chemotherapy

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.