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LiPlaCis

Phase I/II Study to Evaluate the Safety and Tolerability of LiPlaCis in Patients With Advanced or Refractory Tumours

Ensayo de Allarity Therapeutics, Inc. en Fase 1: Tumores solidos avanzados o refractarios · Parte de fase 2: Cancer de mama metastasico, cancer de prostata y cancer de piel.

Fase

Fase 1/2

Estado

Completado

Participantes

50

previstos

Centros

4

Fin del objetivo primario

oct 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en abr 2013.

Qué mide

Dosis maxima tolerada (MTD) y dosis recomendada (RD) mediante la evaluacion de la seguridad y tolerabilidad (one year) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroLiposomal formulations are frequently used today in the treatment of cancer. LiPlaCis is the first targeted liposomal formulation with a tumour triggered release mechanism to undergo clinical development in oncology and it is expected that LiPlaCis will improve the therapeutic index of cisplatin compared to conventional cisplatin. Cisplatin is one of the most widely used drugs in the treatment of cancer due to its documented efficacy in a number of tumour types. Furthermore, it seems highly likely that cisplatin will remain an important drug in the future treatment of cancer. However, the drug is associated with a number of serious toxicities that complicates or necessitates discontinuation of therapy - e.g. need for pre-hydration, neurotoxicity, nausea and vomiting. Thus, there is a well-established need for improving cisplatin therapy in cancer patients. One option here is improving the formulation of the drug, so that a more selective up-take of cisplatin administered takes place at the tumour sites. Based on the results of the pre-clinical studies of LiPlaCis, it seems clear that LiPlaCis offers the potential to improve cisplatin therapy to the benefits of cancer patients. In a prematurely stopped Phase I Dutch study a Recommended Dose (RD) for a Phase II study was never reached which was the aim of the finished Phase I dose escalating part of this study for advanced or refractory solid tumors. In the Phase 2 part of this study, patients with advanced breast cancer with a biopsy examination showing a pattern compatible with sensitivity to LiPlaCis or patients with skin cancer will be included.

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Ficha completa en ClinicalTrials.gov (NCT01861496), actualizada en feb 2022.