WHO ICTRP trial
Study of the Safety and Efficacy of KRT-232 Combined with Ruxolitinib in…
EUCTR2019-004554-29-DE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2019-004554-29-DE |
|---|---|
| Public title | Study of the Safety and Efficacy of KRT-232 Combined with Ruxolitinib in Patients with Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF) Who Have a Suboptimal Response to Ruxolitinib |
| Scientific title | An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Ruxolitinib in Patients with Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF) Who Have a Suboptimal Response to Ruxolitinib |
| Primary sponsor | Kartos Therapeutics, Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | France;United States;Hungary;Spain;Poland;Australia;Bulgaria;Israel;Germany;United Kingdom;Italy |
| Conditions | Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF) MedDRA version: 21.0 Level: LLT Classification code 10074689 Term: Post polycythemia vera myelofibrosis System Organ… |
| Interventions | Product Name: KRT-232 Product Code: KRT-232 (formerly AMG-232) Pharmaceutical Form: Tablet INN or Proposed INN: Navtemadlin Current Sponsor code: KRT-232 Other descriptive name: AMG 232 Concentration unit: mg milligram(s) Concentration… |
| Registration date | Jun 18, 2020 |
| Target size | 36 |
| Secondary IDs | KRT-232-109;147148;2019-004554-29-FR |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: