Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments ly2495655, placebo
Phase phase 2
Sponsor Eli Lilly and Company
Start date December 2011
End date October 2014
Trial size 120 participants
Trial identifier NCT01505530, 12552, I1Q-MC-JDDG

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)
ly2495655
Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.
(Experimental)
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)
ly2495655
Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.
(Placebo Comparator)
Placebo in combination with standard of care chemotherapy (investigator's choice)
placebo
Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.

Primary Outcomes

Measure
Overall survival
time frame: Baseline to study completion (approximately 31 months)

Secondary Outcomes

Measure
Percentage of participants with tumor response (tumor response rate)
time frame: Baseline to study completion (approximately 31 months)
Change in physical performance measures
time frame: Baseline to study completion (approximately 31 months)
Change in patient reported outcomes
time frame: Baseline to study completion (approximately 31 months)
Change in lean body mass
time frame: Baseline to study completion (approximately 31 months)
Progression free survival (PFS)
time frame: Baseline to study completion (approximately 31 months)
Duration of response
time frame: Baseline to study completion (approximately 31 months)

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title A Randomized Phase 2 Placebo-Controlled Study of LY2495655 in Patients With Advanced or Metastatic Pancreatic Cancer Receiving Chemotherapy
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.