WHO ICTRP trial
A Randomized, Placebo Controlled Phase 3 Study of ABT-414 with Concurrent…
NL-OMON47442 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting
Key facts
| Trial ID | NL-OMON47442 |
|---|---|
| Public title | A Randomized, Placebo Controlled Phase 3 Study of ABT-414 with Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Glioblastoma (GBM) with Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance 1) |
| Scientific title | A Randomized, Placebo Controlled Phase 3 Study of ABT-414 with Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Glioblastoma (GBM) with Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance 1) - M13-813 |
| Primary sponsor | AbbVie B.V. |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | 3 |
| Countries | Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Colombia;Czechia;France;Germany;Hong Kong;Ireland;Israel;Italy;Korea (the Republic of);Mexico;Netherlands;New Zealand;Portugal;Puerto… |
| Conditions | Glioblastoma Grade 4 Brain tumor;10029211;Glioblastoma;Grade 4 Brain tumor |
| Interventions | Chemo radiation phase: Subjects will be treated with ABT-414, 2.0 mg/kg or Placebo, intravenous injection 30 to 40 minutes on day 1 of week 1, 3 and 5. In addition, subjects receive standard RT and TMZ (75 mg/m2) during the first 6 weeks… |
| Registration date | Feb 7, 2019 |
| Target size | 30 |
| Secondary IDs | 2015-001166-26;NCT02573324;NL54003.078.15 |
| Registry page | onderzoekmetmensen.nl |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: