CompletedPhase 1/2

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

Denmark50 participantsStarted 2013-04

Plain-language summary

Liposomal 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histological or cytological documented locally advanced or metastatic solid tumour relapsed on 2 or more different prior therapies. From step 5 and extension phase, population limited to Skin Cancer patients (non screened) or metastatic Breast Cancer patients or metastatic castration-resistant prostate cancer patients screened sensitive to LiPlaCis. * Age \>= 18 years. * Life expectancy \>= 3 months. * ECOG performance status of 0 - 1. * Recovered to Grade 1 or less from acute toxicities of prior treatment. * \>= 6 months must have elapsed since patient received cisplatin. * \>= 4 weeks must have elapsed since patient received any investigational medicinal product. * \>= 4 weeks must have elapsed since patient received any radiotherapy(except for palliative radiotherapy on non-target lesions), or treatment with cytotoxic or biologic agents (\>=6 weeks for mitomycin or nitrosoureas). No hormonal treatment is allowed except treatment with corticosteroids at physiological dose and hormonal treatment with LHRH agonists for prostate cancer. * \>=2 weeks must have elapsed since any prior surgery or therapy with G-CSF and GM-CSF. * Adequate condition as evidenced by the following clinical laboratory values: * Absolute neutrophil count (ANC) \>= 1,5 x 10E9/L * Haemoglobin is at least 4,6 mmol/L * Platelets \>= 75 x 10E9/L * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 2,5 x ULN, in case of known liver metastases ALT and AST \…

What they're measuring

Maximum tolerated dose (MTD) and recommended dose (RD) by evaluating the safety and tolerability

Timeframe: one year

Trial details

NCT IDNCT01861496

SponsorAllarity Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10