Clinical trial · Interventional
QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer
A Phase 1b/2 Study to Evaluate the Safety and Efficacy of AMG 655 or AMG 479 in Combination With Gemcitabine as First-Line Therapy for Metastatic Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Pancreas | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 479 | Drug | Ganitumab | ALIAS |
| AMG 655 | Drug | Conatumumab | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Phase 1b AMG 655 3mg/kg
- description
- Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
- interventionNames
- Drug: AMG 655
- type
- EXPERIMENTAL
- label
- Phase 1b AMG 655 10mg/kg
- description
- Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
- interventionNames
- Drug: AMG 655
- type
- EXPERIMENTAL
- label
- Phase 2 AMG 655
- description
- Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDCella 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. PMID 22678353
- BACKGROUNDKindler 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. PMID 22700995
- BACKGROUNDLu, 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;
- BACKGROUNDMcCaffery 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. PMID 23741071
- BACKGROUNDTBD.Validation of the FACT-hepatobiliary questionnaire in metastatic pancreatic cancer population.Journal-004521;