Phase 2
Completed N=138
QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer
Source: ClinicalTrials.gov NCT00630552 ↗Enrolled (actual)
138
Serious AEs
53.7%
Results posted
Oct 2024
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities (DLTs; Phase 1b Portion Only) — 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs; Phase 1b Portion Only) |
0; 0 | — |
| PRIMARY Six Month Overall Survival Rate (Phase 2 Portion Only) |
59.2; 56.6; 49.5 | — |
| SECONDARY Objective Response Rate |
16.67; 14.29; 2.63; 10.26; 2.50 | — |
| SECONDARY Progression-free Survival (PFS) |
5.4; 3.5; 3.9; 5.1; 2.1 | — |
| SECONDARY Overall Survival |
9.0; 8.9; 7.5; 8.7; 5.9 | — |
| SECONDARY Number of Subjects With an Adverse Event |
6; 7; 41; 39; 40 | — |
| SECONDARY Pharmacokinetics of AMG 655, Ganitumab, and Gemcitabine |
55.3; 198; 198; 179; 15.7; 14.8 | — |
| SECONDARY Dose Intensity of Gemcitabine (Phase 2 Portion Only) |
861.40; 906.66; 936.29 | — |
| SECONDARY Duration of Response |
301; 253; 116 | — |
| SECONDARY Incidence of Antibody Formation |
0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Untreated metastatic adenocarcinoma of the pancreas (AJCC Stage IV)
- Subjects with unresectable pancreatic cancer who have had surgery are eligible if fully recovered and greater than 30 days have elapsed since the surgery.
Subjects with a history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence.
- Men or women ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Adequate hematologic, hepatic, renal and coagulation function
- Amylase and lipase ≤ 2.0 x ULN
- Adequately controlled type 1 or 2 diabetic subjects
Exclusion Criteria
- Islet cell, acinar cell carcinoma, non-adenocarcinoma (eg, lymphoma, sarcoma, etc), adenocarcinoma originated from biliary tree or cystadenocarcinoma
- Known central nervous system metastases
- Uncontrolled cardiac disease or any other co-morbid disease that would increase the risk of toxicity
- Adjuvant chemotherapy or chemoradiotherapy
Data sourced from ClinicalTrials.gov (NCT00630552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.