WHO ICTRP trial
Phase II clinical trial with early efficacy testing and adaptive extension for…
EUCTR2019-003192-18-DE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2019-003192-18-DE |
|---|---|
| Public title | Phase II clinical trial with early efficacy testing and adaptive extension for rare malignant tumors |
| Scientific title | Continuous ReAssessment with Flexible ExTension in Rare Malignancies – CRAFT: The NCT PMO-1602 Phase II Trial - CRAFT |
| Primary sponsor | German Cancer Research Center |
| 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): no Therapeutic use (Phase IV): no |
| Countries | Germany |
| Conditions | Metastatic or locally advanced malignancies MedDRA version: 21.1 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04] |
| Interventions | Product Name: Alectinib Product Code: RO5424802/F03 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Alectinib CAS Number: 1256589-74-8 Current Sponsor code: Alectinib Other descriptive name: ALECTINIB HYDROCHLORIDE Concentration… |
| Registration date | Jan 2, 2021 |
| Target size | 175 |
| Secondary IDs | NCT-PMO-1602;NCT04551521 |
| Registry page | clinicaltrialsregister.eu |
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: