Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
WntResearch AB
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Dose Escalating Study of Foxy-5 in Breast-, Colon- or Prostate Cancer Patients
