Metastatic Breast CancerPhase 1NCT02020291
Phase I Study to Evaluate Safety, Tolerability, Anti-Tumour Activity and PK Profiles of Foxy-5 in Metastatic Breast, Colon or Prostate Cancer
A Phase 1 study testing Foxy-5 in people with Metastatic Breast Cancer and Colorectal Cancer, run by WntResearch AB at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Colorectal Cancer, Prostate Cancer
- What is being tested?
- Foxy-5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2013to Nov 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- >= 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Dose Escalating Study to Evaluate the Safety, Tolerability, Anti-Tumour Activity and Pharmacokinetic and Pharmacodynamic Profiles of Foxy-5 in Patients With Metastatic Breast, Colon or Prostate Cancer
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.
- Conditions
- Metastatic Breast Cancer, Colorectal Cancer, Prostate Cancer
- Being tested
- Foxy-5
- Keywords
- Foxy-5, Wnt-5A
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foxy-5Drug
| Study group | Role | What they receive |
|---|---|---|
| Foxy-5 | Experimental | Slow infusion of lyophilised and reconstituted Foxy-5 three times weekly on Monday, Wednesday and Friday for three weeks. Receives: Drug: Foxy-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of Foxy-5
Assessment of adverse events and laboratory abnormalities
Measured: 1 year
Secondary outcomes (13)
Profile for the biomarker NGAL and the amount of circulating tumour cells before and after treatment with Foxy-5
Measured: samples at pre-dose at day 1, pre-dose at day 12 and pre-dose at day 26
Profile for the biomarker 15-PGHD and the amount of circulating tumour cells before and after treatment with Foxy-5
Measured: samples at pre-dose at day 1, pre-dose at day 12 and pre-dose at day 26
Maximum tolerated dose (MTD)
To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of Foxy-5.
Assessment of adverse events and laboratory abnormalities
Measured: 1 year
Area under the plasma concentration curve (AUC) of Foxy-5
The concentration of Foxy-5 in human biological samples will be measured with liquid chromatography with tandem mass spectrometry detection (LC-MS/MS).
Measured: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion. In the Multiple dosing cycles on days 1+3+5 and 15+29
Maximum observed plasma drug concentration (Cmax) of Foxy-5
The concentration of Foxy-5 in human biological samples will be measured with liquid chromatography with tandem mass spectrometry detection (LC-MS/MS).
Measured: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion. In the Multiple dosing cycles on days 1+3+5 and 15+29
Time to maximum observed plasma drug concentration (tmax) of Foxy-5
The concentration of Foxy-5 in human biological samples will be measured with liquid chromatography with tandem mass spectrometry detection (LC-MS/MS).
Measured: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion. In the Multiple dosing cycles on days 1+3+5 and 15+29
Terminal elimination half-life (t½) of Foxy-5
The concentration of Foxy-5 in human biological samples will be measured with liquid chromatography with tandem mass spectrometry detection (LC-MS/MS).
Measured: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion. In the Multiple dosing cycles on days 1+3+5 and 15+29
Total plasma clearance (CL) of Foxy-5
The concentration of Foxy-5 in human biological samples will be measured with liquid chromatography with tandem mass spectrometry detection (LC-MS/MS).
Measured: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion. In the Multiple dosing cycles on days 1+3+5 and 15+29
Volume of distribution (V) of Foxy-5
The concentration of Foxy-5 in human biological samples will be measured with liquid chromatography with tandem mass spectrometry detection (LC-MS/MS).
Measured: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion
Plasma concentration at steady state (Css) of Foxy-5
The concentration of Foxy-5 in human biological samples will be measured with liquid chromatography with tandem mass spectrometry detection (LC-MS/MS).
Measured: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion. In the Multiple dosing cycles on days 1+3+5 and 15+29
Drug accumulation ratio of Foxy-5
The concentration of Foxy-5 in human biological samples will be measured with liquid chromatography with tandem mass spectrometry detection (LC-MS/MS).
Measured: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion
mRNA expression and protein expression of Wnt-5a
Measured: Tumour biopsies obtained prior to day 1 and on day 12
Anti-tumour activity of Foxy-5
Voluntary tumour biopsies
Measured: Prior to Day 1 (-14 days is allowed) and at Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- WntResearch AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020291
- Sponsor's protocol ID
- SMR-2562
- Status last verified
- Feb 2016
- First submitted
- 11 Dec 2013
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalating Study to Evaluate the Safety, Tolerability, Anti-Tumour Activity and Pharmacokinetic and Pharmacodynamic Profiles of Foxy-5 in Patients With Metastatic Breast, Colon or Prostate Cancer
- ClinicalTrials.gov ID
- NCT02020291
- Acronym / sponsor ID
- SMR-2562
- Conditions
- Metastatic Breast Cancer, Colorectal Cancer, Prostate Cancer
- Keywords
- Foxy-5, Wnt-5A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- WntResearch ABIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foxy-5 | Experimental | Drug: Foxy-5Slow infusion of lyophilised and reconstituted Foxy-5 three times weekly on Monday, Wednesday and Friday for three weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foxy-5 | Drug | Foxy-5 |
Primary outcome
Safety and tolerability of Foxy-5
Time frame: 1 year
Assessment of adverse events and laboratory abnormalities
13 secondary outcomes
Profile for the biomarker NGAL and the amount of circulating tumour cells before and after treatment with Foxy-5
Time frame: samples at pre-dose at day 1, pre-dose at day 12 and pre-dose at day 26
Profile for the biomarker 15-PGHD and the amount of circulating tumour cells before and after treatment with Foxy-5
Time frame: samples at pre-dose at day 1, pre-dose at day 12 and pre-dose at day 26
Maximum tolerated dose (MTD)
Time frame: 1 year
Area under the plasma concentration curve (AUC) of Foxy-5
Time frame: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion. In the Multiple dosing cycles on days 1+3+5 and 15+29
Maximum observed plasma drug concentration (Cmax) of Foxy-5
Time frame: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion. In the Multiple dosing cycles on days 1+3+5 and 15+29
Time to maximum observed plasma drug concentration (tmax) of Foxy-5
Time frame: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion. In the Multiple dosing cycles on days 1+3+5 and 15+29
Terminal elimination half-life (t½) of Foxy-5
Time frame: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion. In the Multiple dosing cycles on days 1+3+5 and 15+29
Total plasma clearance (CL) of Foxy-5
Time frame: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion. In the Multiple dosing cycles on days 1+3+5 and 15+29
Volume of distribution (V) of Foxy-5
Time frame: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion
Plasma concentration at steady state (Css) of Foxy-5
Time frame: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion. In the Multiple dosing cycles on days 1+3+5 and 15+29
Drug accumulation ratio of Foxy-5
Time frame: Plasma immediately prior to treatment, instantly after infusion, at 5, 15, 30, minutes 1, 3, 6, 8, 24, 48, 72 and 96 hours after infusion
mRNA expression and protein expression of Wnt-5a
Time frame: Tumour biopsies obtained prior to day 1 and on day 12
Anti-tumour activity of Foxy-5
Time frame: Prior to Day 1 (-14 days is allowed) and at Day 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Foxy-5 in people with Metastatic Breast Cancer and Colorectal Cancer, run by WntResearch AB at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of Foxy-5 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.