WHO ICTRP trial
This global, multicenter, Phase 2 (Part A)/3 (Part B) randomized, controlled…
EUCTR2018-001671-21-CZ · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2018-001671-21-CZ |
|---|---|
| Public title | This global, multicenter, Phase 2 (Part A)/3 (Part B) randomized, controlled, open-label study will evaluate the safety and efficacy of KRT-232 versus BAT for the treatment PMF, post PV MF, or post ET MF in subjects who are relapsed or refractory to JAK inhibitor treatment |
| Scientific title | A Phase 2/3 Randomized, Controlled, Open-Label Study of KRT-232 in Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post-ET-MF) who are Relapsed or Refractory to Janus Kinase (JAK) Inhibitor Treatment - BOREAS |
| 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): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;Portugal;Philippines;Hong Kong;Taiwan;Greece;Spain;Thailand;Israel;Italy;France;Australia;Czechia;Lithuania;Turkey;United Kingdom;Hungary;Czech… |
| Conditions | Primary Or Secondary (Post-PV MF or Post-ET-MF) Myelofibrosis (MF) With Intermediate Or High-Risk TP53 Wild-Type (TP53 WT) Who Are Relapsed Or Refractory to Janus Kinase (JAK) - Inhibitor Treatment. MedDRA version: 20.0 Level: PT… |
| Interventions | Product Name: KRT-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 type: equal Concentration number: 15- Product… |
| Registration date | Oct 9, 2018 |
| Target size | 385 |
| Secondary IDs | KRT-232-101;2018-001671-21-GB |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: