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Clinical Trial of PM14 Administered Intravenously to Patients with Advanced Solid Tumors
THIS STUDY WILL BE DIVIDED INTO TWO PHASES. THE MAIN OBJECTIVE OF THE FIRST PHASE OF THIS TRIAL IS TO ANALYZE THE SAFETY OF PM14, A NEW EXPERIMENTAL DRUG, AT DIFFERENT DOSES. ALSO TO DETERMINE THE EFFECT (IF ANY) OF PM14 ON THEIR DISEASE AND THE POSSIBLE ADVERSE EFFECTS (IF ANY) THAT MAY DEVELOP. THE STUDY, INITIALLY, WILL BE CONDUCTED IN A SMALL GROUP OF PATIENTS WHO WILL BE ADMINISTERED A GIVEN DOSE OF PM14. IF THESE PATIENTS TOLERATE THE DOSE WELL (I.E., IF THEY HAVE FEW OR EASILY TREATABLE ADVERSE EFFECTS), THE NEXT GROUP OF PATIENTS WILL RECEIVE A HIGHER DOSE. THE DOSE WILL CONTINUE TO BE INCREASED UNTIL THE HIGHEST SAFE DOSE OF THE DRUG THAT CAN BE ADMINISTERED WITHOUT CAUSING SERIOUS OR EASILY TREATABLE ADVERSE EFFECTS IS FOUND.
Technical Summary
- PHASE I, OPEN-ENDED, CLINICAL AND PHARMACOKINETIC STUDY OF DOSE ESCALATION OF PM14 ADMINISTERED INTRAVENOUSLY TO PATIENTS WITH ADVANCED SOLID TUMORS
- Code EudraCT: 2017-001118-27
- Protocol number: PM14-A-001-17
- Promoter: Pharma Mar, S.A.
- Molecule/Drug: PM14
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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