QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer

Summary

This is a multi-center, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine as first-line treatment of subjects with metastatic pancreatic cancer. Part 1 is an open-label, dose-escalation phase 1b segment to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with gemcitabine. Enrollment into part 1 of the study has been completed. Part 2 is a randomized, placebo-controlled phase 2 segment to estimate the efficacy as assessed by 6 month survival of AMG 655, AMG 479, or AMG 655-placebo in combination with gemcitabine. The phase 2 segment that will commence after dose selection in part 1. In part 2, subjects will be randomized 1:1:1 to AMG 655, AMG 479, or placebo in combination with gemcitabine.

Timeline

Start

2007-06

Primary completion

2010-01

Completion

2012-04

Publications

• Background Cella D, Butt Z, Kindler HL, Fuchs CS, Bray S, Barlev A, Oglesby A. Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer. Qual Life Res. 2013 Jun;22(5):1105-12. doi: 10.1007/s11136-012-0217-4. Epub 2012 Jun 8.
• Background Kindler HL, Richards DA, Garbo LE, Garon EB, Stephenson JJ Jr, Rocha-Lima CM, Safran H, Chan D, Kocs DM, Galimi F, McGreivy J, Bray SL, Hei Y, Feigal EG, Loh E, Fuchs CS. A randomized, placebo-controlled phase 2 study of ganitumab (AMG 479) or conatumumab (AMG 655) in combination with gemcitabine in patients with metastatic pancreatic cancer. Ann Oncol. 2012 Nov;23(11):2834-2842. doi: 10.1093/annonc/mds142. Epub 2012 Jun 13.
• Background Lu, JF.Exposure-response analysis to facilitate phase 3 dose selection for Ganitumumab (AMG 479) in combination with Gemcitabine to treat metastatic pancreatic cancer.Journal-000728;
• Background McCaffery I, Tudor Y, Deng H, Tang R, Suzuki S, Badola S, Kindler HL, Fuchs CS, Loh E, Patterson SD, Chen L, Gansert JL. Putative predictive biomarkers of survival in patients with metastatic pancreatic adenocarcinoma treated with gemcitabine and ganitumab, an IGF1R inhibitor. Clin Cancer Res. 2013 Aug 1;19(15):4282-9. doi: 10.1158/1078-0432.CCR-12-1840. Epub 2013 Jun 5.
• Background TBD.Validation of the FACT-hepatobiliary questionnaire in metastatic pancreatic cancer population.Journal-004521;

Drugs

Indications