WHO ICTRP trial

Trial of different schemes of PM14 alone and in combination with radiotherapy in…

EUCTR2021-001186-20-ES · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2021-001186-20-ES
Public title Trial of different schemes of PM14 alone and in combination with radiotherapy in soft tissue sarcomas and other solid tumors
Scientific title Phase Ib/II multicohort trial of different schemes of PM14 in monotherapy and in combination with radiotherapy in soft tissue sarcomas and other solid tumors - PRIME
Primary sponsor GRUPO ESPAÑOL DE INVESTIGACIÓN EN SARCOMAS
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 United States;Spain
Conditions Advanced soft tissue sarcoma and other solid tumors;Therapeutic area: Diseases [C] - Cancer [C04]
Interventions Product Name: PM14 Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: PM14 Other descriptive name: PM14 Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 1-
Registration date Jun 23, 2021
Target size 195
Secondary IDs GEIS-83
Registry page clinicaltrialsregister.eu

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