Clinical trial NCT02655952 (phase 1, status: completed)
Conditions: metastatic breast cancer, metastatic colon cancer, metastatic prostate cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: foxy-5
SMILES: CSCC[C@H](NC=O)C(=O)N[C@@H](CC(O)=O)C(=O)NCC(=O)N[C@@H](CS)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(O)=O
Eligibility criteria:

        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

               -  Must have an evaluable tumour appropriate for biopsy as determined by the
                  Investigator.

               -  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

               -  Patients in active anti-coagulating treatment must be evaluated according to
                  local standards on the discretion of the Investigator..

               -  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:

          -  Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease)

               -  Any active infection requiring antibiotic treatment

               -  Known infection with human immunodeficiency virus (HIV) or hepatitis virus

               -  Active heart disease including myocardial infarction or congestive heart failure
                  within the previous 6 months, symptomatic coronary artery disease, or symptomatic
                  arrhythmias currently requiring medication

               -  Known or suspected active central nervous system (CNS) metastasis. (Patients
                  stable 8 weeks after completion of treatment for CNS metastasis are eligible)

               -  Impending or symptomatic spinal cord compression or carcinomatous meningitis

               -  Requiring immediate palliative surgery and/or radiotherapy(except for a single
                  dose of palliative radiotherapy)

               -  Pre-existing neuropathy, i.e., Grade >2 neuromotor or neurosensory toxicity

               -  Participation in other clinical studies within 4 weeks of first dose of study
                  treatment

               -  Previous exposure to Foxy-5

               -  History of severe allergic or hypersensitive reactions to excipients

               -  Pregnant or breastfeeding women

               -  Active and/or within the last 5 years histologically confirmed diagnosis of
                  malignant melanoma, gastric cancer, pancreatic cancer, lung cancer or
                  nasopharyngeal cancer

               -  Severe or uncontrolled chronic or uncontrolled systemic disease (e. g. severe
                  respiratory or cardiovascular disease)

               -  Other medications or conditions that in the Investigator's opinion would
                  contraindicate study participation of safety reasons or interfere with the
                  interpretation of study results