Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM14 Administered Intravenously to Patients with Advanced Solid Tumors
PharmaMar
Summary
Despite recent advances in the treatment of solid tumors in general, advanced (metastatic) disease remains mostly incurable and there is an urgent need to develop new therapeutic options for these patients, particularly investigational drugs with novel mechanisms of action. The investigation of new combination regimens of non-crossresistant agents with acceptable-and not completely overlapping-toxicities has been a major way to improve response rate and outcome of patients with advanced solid tumors.
Description
First-in-human, open-label, dose-finding, phase I trial, using a classical 3+3 design followed by a continual reassessment method (CRM). Patients will be included in cohorts of a minimum of three or six patients to receive PM14 at successively increasing dose levels, starting at 0.25 mg/m\^2 for the Days 1 and 8 schedule. For the Day 1 schedule, the starting dose will be 4.5 mg/m\^2. Dose escalation will proceed only after all the patients fully evaluable for DLT included at one dose level have completed the first cycle (i.e., three weeks). Once the RD has been determined, expansion cohorts w…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Voluntarily signed and dated written informed consent (IC), obtained prior to any specific study procedure. 2. Age ≥18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1 4. For the Dose escalation phase: Patients with pathologically confirmed diagnosis of advanced solid tumors for whom no curative standard therapy exists. For the Expansion phase: Patients with pathologically confirmed diagnosis of one of the following malignancies, for whom the standard of care therapies have failed, or are intolerant to standard of care therapies…
Interventions
- DrugPM14
PM14 drug product is provided as a sterile lyophilized powder for concentrate for solution for infusion with a strength of 5.0 mg of the active moiety. Patients will receive PM14 as an i.v. infusion in a total volume of 100 mL of 0.9% sodium chloride at the first three dose escalation levels. Thereafter, the volume of infusion can be increased to 250 mL.
Locations (9)
- Massachusetts General HospitalBoston, Massachusetts
- MD Anderson Cancer CenterHouston, Texas
- Gustave RoussyVillejuif, París
- Hospital Universitari Vall d'HebronBarcelona, Catalonia
- Hospital General Universitario Gregorio MarañónMadrid, Madrid
- Clinica Universidad de NavarraMadrid, Madrid