NCT01505530

A Randomized Phase 2 Placebo-Controlled Study of LY2495655 in Patients With Advanced or Metastatic Pancreatic Cancer Receiving Chemotherapy

Completed Phase 2 Results posted Last updated 6 September 2019

What this trial tests

Phase 2 trial testing LY2495655 in Pancreatic Cancer in 125 participants. Completed in 1 January 2016.

Timeline

1 December 2011

Primary endpoint
1 October 2014

1 January 2016

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	125
Start date	1 December 2011
Primary completion	1 October 2014
Estimated completion	1 January 2016
Sites	21 locations across United States, Canada, Israel, Norway, United Kingdom

Drugs / interventions tested

• LY2495655 — full drug profile →
• Placebo
• Standard of Care Chemotherapy — full drug profile →

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Beyond TGFβ: roles of other TGFβ superfamily members in cancer.
   Wakefield LM, Hill CS. · · 2013 · cited 321× · PMID 23612460 · DOI 10.1038/nrc3500
2. Cachexia: A systemic consequence of progressive, unresolved disease.
   Ferrer M, Anthony TG, Ayres JS, Biffi G, et al · · 2023 · cited 180× · PMID 37116469 · DOI 10.1016/j.cell.2023.03.028
3. Cancer-induced muscle wasting: latest findings in prevention and treatment.
   Aversa Z, Costelli P, Muscaritoli M. · · 2017 · cited 146× · PMID 28529552 · DOI 10.1177/1758834017698643
4. Pancreas Cancer-Associated Weight Loss.
   Hendifar AE, Petzel MQB, Zimmers TA, Denlinger CS, et al · · 2019 · cited 126× · PMID 30591550 · DOI 10.1634/theoncologist.2018-0266
5. Myostatin inhibitors as therapies for muscle wasting associated with cancer and other disorders.
   Smith RC, Lin BK. · · 2013 · cited 118× · PMID 24157714 · DOI 10.1097/spc.0000000000000013
6. Pancreatic Cancer and Cachexia-Metabolic Mechanisms and Novel Insights.
   Poulia KA, Sarantis P, Antoniadou D, Koustas E, et al · · 2020 · cited 96× · PMID 32466362 · DOI 10.3390/nu12061543
7. Molecular Pathways: Cachexia Signaling-A Targeted Approach to Cancer Treatment.
   Miyamoto Y, Hanna DL, Zhang W, Baba H, et al · · 2016 · cited 89× · PMID 27340276 · DOI 10.1158/1078-0432.ccr-16-0495
8. LY2495655, an antimyostatin antibody, in pancreatic cancer: a randomized, phase 2 trial.
   Golan T, Geva R, Richards D, Madhusudan S, et al · · 2018 · cited 88× · PMID 30051975 · DOI 10.1002/jcsm.12331