A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination with Gemcitabine as First-line Therapy for Metastatic Adenocarcinoma of the Pancreas

Phase 3

Completed

• Conditions: aandoening aan de alvleesklier; metastatic pancreatic adenocarcinoma; pancreatic cancer

• Registration Number: NL-OMON38111
• Lead Sponsor: Amgen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 19

Inclusion Criteria

- Subjects must have histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas
- ECOG score of 0 or 1
- Men or women >/<= 18 years of age
Please see the protocol page 38 and 39 for a complete overview of the inclusion criteria

Exclusion Criteria

- Currently treated or previously treated for pancreatic cancer
Please see the protocol page 39 and 40 for a complete overview of the exclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primairy endpoint of the study is overall survival.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints of the study are:<br /><br>* Progression-free survival, survival rate at 12-months, and at 3, 6, 9, 18,<br /><br>and 24 months, objective response rate, time to disease progression, duration<br /><br>of response, disease control rate (PR+CR+SD);<br /><br>* Incidence of subject adverse events, laboratory abnormalities and<br /><br>immunogenicity;<br /><br>* AMG 479 dose exposure, dose intensity and PK parameters in all subjects;<br /><br>* Gemicitabine dose exposure, dose intensity in all subjects, and gemcitabine<br /><br>PK parameters in a subset of subjects;<br /><br>* The change in hepatobiliary symptoms using the FACT-Hep Hepatobiliary<br /><br>subscale (FACT-Hep HS).</p><br>