WHO ICTRP trial
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of…
NL-OMON38111 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting
Key facts
| Trial ID | NL-OMON38111 |
|---|---|
| Public title | 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 |
| Scientific title | 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 - GAMMA |
| Primary sponsor | Amgen |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | 3 |
| Countries | Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Czechia;Denmark;Finland;France;Germany;Greece;Hong Kong;Hungary;India;Italy;Korea (the Democratic Peoples Republic of);Latvia;Lithuania;Netherlands… |
| Conditions | aandoening aan de alvleesklier metastatic pancreatic adenocarcinoma pancreatic cancer;metastatic pancreatic adenocarcinoma;pancreatic cancer |
| Interventions | Subjects (n=825) will be randomized in a 2:2:1 ratio in one of 3 arms: * Arm 1: Placebo IV days 1 and 15 of a 28 day cycle plus gemcitabine at 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle * Arm 2: AMG 479 at 12 mg/kg IV days 1… |
| Registration date | Apr 6, 2012 |
| Target size | 19 |
| Secondary IDs | 2010-020398-18;NCT01231347;NL33867.060.10 |
| Registry page | onderzoekmetmensen.nl |
At a glance
- No Results available
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: