Overview

Phase I Study to Evaluate Safety, Tolerability, Anti-Tumour Activity and PK Profiles of Foxy-5 in Metastatic Breast, Colon or Prostate Cancer

Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
WntResearch AB
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

- 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:

- 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

- 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

- History of severe allergic or hypersensitive reactions to excipients

- Pregnant or breastfeeding women

- Chronic immunosuppressant use (e.g. systemic steroids for treatment of autoimmune
disease)

- History of second malignancy, including histologically confirmed diagnosis of
malignant melanoma except for carcinoma in situ or basal cell carcinoma

- 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