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

Brief summary public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With Dose Limiting Toxicities (DLTs; Phase 1b Portion Only) [28 days]. Count Of Participants, Participants. Phase 1b AMG 655 3mg/kg (n=6): 0; Phase 1b AMG 655 10mg/kg (n=7): 0.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Six Month Overall Survival Rate (Phase 2 Portion Only) [6 months]. Number, percentage of participants (95% Confidence Interval). Phase 2 AMG 655 (n=41): 59.2 (42.3 to 72.7); Phase 2 AMG 479 (n=42): 56.6 (40.8 to 69.7); Phase 2 AMG 655-placebo (n=42): 49.5 (33.4 to 63.7).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Objective Response Rate [From start of study treatment through up to 36 months]. Number, percentage of responders (95% Confidence Interval). Phase 1b AMG 655 3mg/kg (n=6): 16.67 (0.42 to 64.12); Phase 1b AMG 655 10mg/kg (n=7): 14.29 (0.36 to 57.87); Phase 2 AMG 655 (n=38): 2.63 (0.07 to 13.81); Phase 2 AMG 479 (n=39): 10.26 (2.87 to 24.22); Phase 2 AMG 655-placebo (n=40): 2.50 (0.06 to 13.16).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression-free Survival (PFS) [From start of study treatment through up to 36 months]. Median, Months (95% Confidence Interval). Phase 1b AMG 655 3mg/kg (n=6): 5.4 (5.3 to 5.6); Phase 1b AMG 655 10mg/kg (n=7): 3.5 (1.8 to 13.4); Phase 2 AMG 655 (n=41): 3.9 (3.4 to 5.4); Phase 2 AMG 479 (n=42): 5.1 (3.2 to 6.0); Phase 2 AMG 655-placebo (n=42): 2.1 (1.9 to 3.3).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival [From start of study treatment through up to 36 months]. Median, Months (95% Confidence Interval). Phase 1b AMG 655 3mg/kg (n=6): 9.0 (5.6 to 17.0); Phase 1b AMG 655 10mg/kg (n=7): 8.9 (6.9 to 18.5); Phase 2 AMG 655 (n=41): 7.5 (4.8 to 10.0); Phase 2 AMG 479 (n=42): 8.7 (5.3 to 12.2); Phase 2 AMG 655-placebo (n=42): 5.9 (4.1 to 9.7).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Subjects With an Adverse Event [From start of study treatment through up to 44 weeks]. Count Of Participants, Participants. Phase 1b AMG 655 3mg/kg (n=6): 6; Phase 1b AMG 655 10mg/kg (n=7): 7; Phase 2 AMG 655 (n=41): 41; Phase 2 AMG 479 (n=40): 39; Phase 2 AMG 655-placebo (n=40): 40.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Pharmacokinetics of AMG 655, Ganitumab, and Gemcitabine [From start of study treatment through up to 48 weeks]. Mean, μg/mL (Standard Deviation). Cmax for AMG 655: Phase 1b AMG 655 3mg/kg (n=5): 55.3 (11.3); Phase 1b AMG 655 10mg/kg (n=6): 198 (32.5); Phase 2 AMG 655 (n=11): 198 (52.7). Cmax for AMG 479: Phase 2 AMG 479 (n=13): 179 (55.2). Cmax for gemcitabine - Day 1: Phase 1b AMG 655 3mg/kg (n=5): 15.7 (7.79); Phase 1b AMG 655 10mg/kg (n=6): 14.8 (7.84). Cmax for gemcitabine - Day 8: Phase 1b AMG 655 3mg/kg (n=5): 10.5 (5.90); Phase 1b AMG 655 10mg/kg (n=6): 11.2 (5.76).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Dose Intensity of Gemcitabine (Phase 2 Portion Only) [From start of study treatment through up to 40 weeks]. Mean, mg/m^2 /infusion (Standard Deviation). Phase 2 AMG 655 (n=41): 861.40 (119.45); Phase 2 AMG 479 (n=40): 906.66 (115.76); Phase 2 AMG 655-placebo (n=40): 936.29 (79.58).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Duration of Response [From objective response through up to 36 months]. Median, Days (Full Range). Phase 2 AMG 655 (n=1): 301 (301 to 301); Phase 2 AMG 479 (n=4): 253 (60 to 472); Phase 2 AMG 655-placebo (n=1): 116 (116 to 116).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Incidence of Antibody Formation [From start of treatment up to 40 weeks]. Count Of Participants, Participants. Phase 1b AMG 655 3mg/kg (n=6): 0; Phase 1b AMG 655 10mg/kg (n=7): 0; Phase 2 AMG 655 (n=41): 0; Phase 2 AMG 479 (n=42): 0; Phase 2 AMG 655-placebo (n=42): 0.