Condition: Advanced Soft-tissue Sarcoma · Advanced L-sarcomas · Other Advanced Sarcomas · Sponsor: Grupo Espanol de Investigacion en Sarcomas
Phase Ib/II, multicohort, single arm, open-label, multicenter, international clinical trial, with 6 cohorts (advanced STS, advanced L-sarcomas, other advanced sarcomas, advanced solid tumors, and localized STS) with 4 sites in Spain for phase I. The aim of this study is to explore different infusions of PM14 (longer or repeated) in order to obtain a potentially better efficacy and similar toxicity profile in advanced soft tissue sarcoma patients as monotherapy and also in other solid tumors as concomitant treatment with radiation therapy. Treatment Cohort A A phase I dose-finding stage for PM14 is planned with an estimated number of 20-25 patients. PM14 will be tested at different dose levels in 24-h IV infusion on day 1 of 21-day cycles, up to progression or unacceptable toxicity. Premedication with dexamethasone is recommended on the day before treatment initiation. Cohort B A phase I dose-finding stage for PM14 is planned with an estimated number of 20-25 patients. PM14 will be tested at different dose levels in 3-h IV infusion during 3 consecutive days (days 1-3) of 21-day cycles, up to progression or unacceptable toxicity. Premedication with dexamethasone is recommended on the day before treatment initiation. Cohort E PM14 will be administered at the recommended phase II dose (RP2D) according to the most convenient scheme. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation. Cy…
This description comes directly from the study's public registry record.
Patricio Ledesma · 971 439 900 · ensayos@sofpromed.com
Claudia Marcote · 971 439 900 · cmarcote@sofpromed.com
Always discuss trial participation with your own doctor first.
| Hospital Universitario Miguel Servet | Zaragoza, Aragon, Spain | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona, Catalonia, Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona, Catalonia, Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz | Madrid, Madrid, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05146440