Status and phase
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About
The Wnt proteins belong to a family of proteins that have been demonstrated to play a role in the formation and dissemination of tumours. The present project focuses on the critical role of the Wnt-5a protein in the pathobiological processes that lead to metastatic cancer disease.
WntResearch has identified a formylated 6 amino acid peptide fragment, named Foxy-5, which mimick the effects of Wnt-5a to impair migration of epithelial cancer cells and thereby acting anti-metastatic. The aim of the present clinical phase 1 trial is to establish the recommended dose for a clinical phase 2 study and thereby further develop Foxy-5 as a first in class anti-metastatic cancer drug. Foxy-5 is designed to inhibit the development of metastasis by reducing the motility of cancer cells and should thereby increase the survival rates of patients with solid malignant tumours.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Males and females of at least 18 years of age
Histologically/cytologically documented diagnosis of metastatic breast, colon or prostate cancer, refractory to standard therapy or for which no curative therapy exists
Loss of or reduced Wnt-5a protein expression in primary or metastatic tumour cells, characterised by IHC analysis
Eastern Cooperative Oncology Group (ECOG) performance status of <= 1
Life expectancy of at least 3 months
Unresectable disease, i.e. the metastases cannot be surgically removed with a curative intent
>= 4 weeks must have elapsed since the patient has received any other IMP
>=4 weeks must have elapsed since the patient has received any anti cancer treatment; including radiotherapy (except for single dose of palliative radiotherapy), cytotoxic chemotherapy, biologic agents or targeted therapy
>= 2 weeks must have elapsed since any prior surgery or therapy with bone marrow stimulating factors
Adequate haematological functions as defined by:
Absolute neutrophil count >= 1.5 10E9/L
Platelets >= 100 10E9/L
Hemoglobin >= 5.6 mmol/L
Adequate hepatic function as defined by:
Total bilirubin <= 1.5 x the upper limit of normal (ULN)
Aspartate aminotransferase (AST) <= 2.5 x ULN*
Alanine aminotransferase (ALT) <= 2.5 x ULN*
* For patients with liver metastasis adequate hepatic function is defined by AST <= 5 x ULN and ALT <= 5 ULN.
Adequate renal function as defined by Serum creatinine <= 1,5 x ULN
Provision of written informed consent
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
Sexually active males and females of child-producing potential, must use adequate contraception (intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release) or diaphragm always with spermicidal jelly and a male condom) for the study duration and at least six months afterwards
Exclusion criteria
Primary purpose
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Interventional model
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31 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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