Phase 3
N=800
QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas
Adenocarcinoma of the Pancreas · Advanced Solid Tumors · Cancer · Cancer of Pancreas · Cancer of the Pancreas
Bottom Line
View on ClinicalTrials.gov: NCT01231347 ↗Enrolled (actual)
800
Serious AEs
10.2%
Results posted
Jul 2024
Primary outcome: Primary: 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 Pancreas — 7.0; 7.1; 7.2 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AMG 479 (Drug); Placebo (Drug); gemcitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NantCell, Inc.
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 Pancreas |
7.0; 7.1; 7.2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Untreated metastatic adenocarcinoma of the pancreas
- Adequate hematologic, renal and liver function
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
Exclusion Criteria
- Prior chemotherapy or radiotherapy for pancreatic cancer
- Central nervous system metastases
- External biliary drain
Data sourced from ClinicalTrials.gov (NCT01231347). 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.