18 and older, any sex, with Adenocarcinoma of the Pancreas or Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Determine if the Treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in Combination With Gemcitabine Improves Overall Survival as Compared With Placebo in Combination With Gemcitabine in Subjects With Metastatic Adenocarcinoma of the PancreasPrimary· From randomization up to 20 months
The primary endpoint of the study was OS, defined as the time from randomization to death.
Group
Value
95% CI
AMG 479 12 mg/kg Dose + Gemcitabine
7.0
6.2 – 8.5
AMG 479 20 mg/kg + Gemcitabine
7.1
6.4 – 8.5
Placebo + Gemcitabine
7.2
6.3 – 8.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from screening through 30 days after the last dose of last protocol specified therapy, up to 20 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo + Gemcitabine
Serious: 33/317 (10%)
Deaths: 202/322
AMG 479 12 mg/kg Dose + Gemcitabine
Serious: 30/315 (10%)
Deaths: 210/318
AMG 479 20 mg/kg + Gemcitabine
Serious: 18/160 (11%)
Deaths: 101/160
Serious adverse events (36 terms)
Reaction
System
Placebo + Gemcitabine
AMG 479 12 mg/kg Dose + Ge…
AMG 479 20 mg/kg + Gemcita…
Pancreatic Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Death
General disorders
—
—
—
Pancreatic Carcinoma Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Cachexia
Metabolism and nutrition disorders
—
—
—
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
—
—
—
General Physical Health Deterioration
General disorders
—
—
—
Acute Myocardial Infarction
Cardiac disorders
—
—
—
Cardiac Failure
Cardiac disorders
—
—
—
Abdominal Pain
Gastrointestinal disorders
—
—
—
Sudden Death
General disorders
—
—
—
Adenocarcinoma Pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival. The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01708161 — A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors
· Phase 1, PHASE2
· terminated
NCT01562899 — A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors
· Phase 1, PHASE2
· terminated
NCT01318642 — Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas
· Phase 2
· terminated
NCT00819169 — QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors
· Phase 1, PHASE2
· terminated
NCT00791154 — QUILT-2.013: First-Line Treatment for Extensive Stage Small Cell Lung Cancer
· Phase 1, PHASE2
· terminated
Other recruiting trials for Adenocarcinoma of the Pancreas
Currently open trials in the same condition.
NCT06582342 — Is the 3D-PANC MSP Model Superior to CT for Assessing Response to Neoadjuvant Treatment in PCA Patients?
· recruiting
NCT05116072 — Efficacy and Safety of TPIAT for Resectable Adenocarcinoma of the Pancreas Region at High Risk of Postoperative Fistula
· Phase 1, PHASE2
· recruiting
Other NantCell, Inc. trials
Trials by the same sponsor.
NCT03127098 — QUILT-3.040: ETBX-011 (Ad5 [E1-, E2b-]-CEA(6D)) Vaccine in Combination With ALT-803 (Super-agonist IL-15) in Subjects Ha
· Phase 1, PHASE2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NantCell, Inc.
Last refreshed: 16 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01231347.