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Spots Global Cancer Trial Database for PM14 Administered Intravenously to Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: PM14 Administered Intravenously to Patients With Advanced Solid Tumors

Official Title: Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM14 Administered Intravenously to Patients With Advanced Solid Tumors

Study ID: NCT05076396

Interventions

PM14

Study Description

Brief 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.

Detailed 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 will be included to have a minimum of 20 fully evaluable patients per indication (tumor type) treated in the Expansion phase (regardless of the schedule administered), and thus have an adequate number of patients to assess safety. The indications of these patients will be chosen depending on the efficacy data obtained during dose escalation. Patients treated at the expansion cohorts will be evaluable by the Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) and/or by serum markers only in patients with prostate cancer (prostate specific-antigen \[PSA\]) or ovarian cancer (carbohydrate antigen-125 \[CA-125\]) according to the Prostate-Specific Antigen Working Group Recommendations (PSAWGR) and the Gynecologic Cancer Intergroup (GCIG) specific criteria, respectively.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Massachusetts General Hospital, Boston, Massachusetts, United States

MD Anderson Cancer Center, Houston, Texas, United States

Gustave Roussy, Villejuif, París, France

Hospital Universitari Vall d'Hebron, Barcelona, Cataluña, Spain

Hospital General Universitario Gregorio Marañón, Madrid, Comunidad De Madrid, Spain

Clinica Universidad de Navarra, Madrid, Comunidad De Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz, Madrid, Comunidad De Madrid, Spain

Hospital Universitario 12 de Octubre, Madrid, Comunidad De Madrid, Spain

Hospital Universitario Madrid Sanchinarro, Madrid, Comunidad De Madrid, Spain

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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