Colon CancerPhase 2NeoFoxNCT03883802
Foxy-5 as Neo-Adjuvant Therapy in Subjects With Wnt-5a Low Colon Cancer
A Phase 2 study testing Foxy-5, FOLFOX regimen and Tumour resection (colon cancer surgery) in people with Colon Cancer, run by WntResearch AB at 1 site in Spain.
Trial summary
Phase II study investigating the safety, tolerability and effect on disease reccurence of Foxy-5 as neo-adjuvant therapy in resected colon cancer patients treated with FOLFOX chemotherapy regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Foxy-5, FOLFOX regimen and Tumour resection (colon cancer surgery)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 12 Apr 2019to 14 Dec 2024
- Phase
- Phase 2
- 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
- Ability to understand and willingness to provide written informed consent before any trial-related activities.
- 18 years of age or older.
- Male or female subjects with adenocarcinoma of the colon, judged by CT or MRI as either one of the following stages per TNM classification of colon cancer (8th edition, 2017):
- T1-4, N1-2, M0 or T4, N0, M0 and who are considered to fulfil the local criteria for adjuvant post- operative chemotherapy after scheduled surgery.
- Scheduling of surgery according to local practice allows at least 9 pre- surgery administrations of Foxy-5 for the subject. (Please note: surgery should not be postponed for trial purposes.)
- Sexually active women of childbearing potential (WOCBP) and males with WOCBP partners who are randomized to the Foxy-5 Arm must use a highly effective method of contraception for the treatment duration and for 28 days after last Foxy-5.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Clinical laboratory values at screening:
- Absolute neutrophil count ≥1.5 x 109/L
- Haemoglobin ≥ 9 g/dL
- Platelets ≥ 100 x 109/L
- Aspartate Transaminase (AST) and Alanine Transaminase (ALT)
- ≤1.5x Upper Limit of Normal (ULN)
- Serum bilirubin ≤1.5 x the ULN
- Creatinine clearance >60 mL/min (determined by Cockcroft-Gault Equation).
Who cannot join
- Assessed as not suitable or unable to tolerate adjuvant chemotherapy.
- Evidence of distant metastatic (M1) disease at Screening (N1-2 is allowed).
- Any surgery (except tumour biopsy) or therapy with immune suppressive agents or bone marrow stimulating factors within the last two weeks prior to randomization.
- Any active infection requiring IV antibiotic treatment at the time of screening.
- History of hematologic or primary solid tumour malignancy.
- Pregnant or breastfeeding women.
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- Currently participating in another trial and receiving trial therapy or received investigational therapy within 4 weeks of the first dose of Foxy-5.
- Any other condition or treatment that, in the opinion of the Investigator, might interfere with the trial or current drug or substance abuse.
- Inability to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial.
- Unlikely to comply with the protocol requirements, instructions and trial-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial.
- Legal incapacity or limited legal capacity.
- Any condition, which results in an undue risk for the subject during the trial participation according to the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicentre, Open-Label Controlled Phase II Trial of Foxy-5 as Neo-Adjuvant Therapy in Subjects With Wnt-5a Low Colon Cancer
Phase II study investigating the safety, tolerability and effect on disease reccurence of Foxy-5 as neo-adjuvant therapy in resected colon cancer patients treated with FOLFOX chemotherapy regimen. It is a two-arm study and patients will be randomised to receive either standard therapy (surgery + FOLFOX 6 months regimen) or standard therapy + neo-adjuvant administration of Foxy-5 prior to- and following surgery (maximum of 39 administrations) until initiation of FOLFOX therapy.
Read the detailed description
Foxy-5 is a synthetic hexapeptide with a formylated N-terminus, derived from the protein sequence of the Wnt-5a protein. Low/no expression levels of Wnt-5 protein in primary tumour cells have been correlated to high risk of recurrent metastatic disease and shortened survival in several different types of cancer patients, including colon cancer.
Current standard therapy involves surgical removal of the tumour followed by 6 months treatment with chemotherapy (FOLFOX). Foxy-5 is expected to decrease migration of cancer cells, in subjects with low/absent levels of Wnt-5a protein in their primary tumour and hence result in lower recurrence and a better overall survival. The trial intends to establish the safety and tolerability of Foxy-5 and to evaluate early signs of anti-metastatic activity in subjects with resectable colon cancer.
- Conditions
- Colon Cancer
- Being tested
- Foxy-5, FOLFOX regimen, Tumour resection (colon cancer surgery)
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foxy-5Drug
Lyophilized powder for solution for intravenous infusion
FOLFOX regimenDrug
6 months treatment regimen
Tumour resection (colon cancer surgery)Procedure or surgery
Surgical removal of patients colon cancer
| Study group | Role | What they receive |
|---|---|---|
| Foxy-5 | Experimental | Arm will receive Foxy-5 as neo-adjuvant therapy prior to surgical removal of tumour and afterwards until initiation of FOLFOX 6 months regimen Receives: Drug: Foxy-5; Drug: FOLFOX regimen; Procedure: Tumour resection (colon cancer surgery) |
| Standard therapy | Active comparator | Surgical removal of tumour followed by 6 months FOLFOX regimen Receives: Drug: FOLFOX regimen; Procedure: Tumour resection (colon cancer surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The incidence of adverse events (AEs) related to Foxy-5 administration of Grade 3 and higher according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) and the Clavien-Dindo classification of surgical complications. cancer.
Measured: From date of randomization until 28 days after the last dose of Foxy-5, assessed up to 120 days
ctDNA as surrogate marker for disease free period
The level of ctDNA in plasma of subjects with Wnt-5a low colon cancer as a surrogate parameter for disease recurrence in subjects with Wnt-5a low colon cancer treated with Foxy-5 compared to subjects with Wnt-5a low colon cancer who are in the Control Arm.
Measured: 2 years after resection of colon cancer
Secondary outcomes (4)
Overall survival
OS at 2 years after resection of the colon cancer
Measured: 2 years after resection of tumour
Disease-Free Survival
DFS at 2 years after resection of the colon cancer
Measured: 2 years after resection of tumour
Recurrence-Free Interval
Recurrence-free interval (RFI) defined as the time from randomization to tumour recurrence.
Measured: study start to 2 years after resection of tumour
ctDNA in Wnt-5a high patients
The level of ctDNA in plasma of subjects with Wnt-5a high colon cancer.
Measured: 2 years after resection of tumour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start12 Apr 2019
- Primary completion14 Dec 2024 (estimated)
- Study completion14 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-arm study, 1 to 1 randomization: treatment group and standard therapy
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WntResearch AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SMS-Oncology BV, SAGA diagnostics AB, Unilabs A/S, BioVica AB, Institut Català d'Oncologia
- Responsible party
- Sponsor
- Investigators
- Ramon Salazar, MD, Principal investigator, Institut Català d'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883802
- Sponsor's protocol ID
- SMS-0472B
- Other IDs
- 2018-003074-27, 2018
- Acronym
- NeoFox
- Status last verified
- Dec 2022
- First submitted
- 26 Dec 2018
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicentre, Open-Label Controlled Phase II Trial of Foxy-5 as Neo-Adjuvant Therapy in Subjects With Wnt-5a Low Colon Cancer
- ClinicalTrials.gov ID
- NCT03883802
- Acronym / sponsor ID
- NeoFox / SMS-0472B
- Conditions
- Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- WntResearch ABIndustry (pharma, biotech, devices)
- Collaborators
- SMS-Oncology BV, SAGA diagnostics AB, Unilabs A/S, BioVica AB, Institut Català d'Oncologia
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 14 Dec 2024 (estimated)
- Study completion
- 14 Dec 2024 (estimated)
- First posted
- 21 Mar 2019 (actual)
- 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.
Phase II study investigating the safety, tolerability and effect on disease reccurence of Foxy-5 as neo-adjuvant therapy in resected colon cancer patients treated with FOLFOX chemotherapy regimen. It is a two-arm study and patients will be randomised to receive either standard therapy (surgery + FOLFOX 6 months regimen) or standard therapy + neo-adjuvant administration of Foxy-5 prior to- and following surgery (maximum of 39 administrations) until initiation of FOLFOX therapy.
Detailed description
Foxy-5 is a synthetic hexapeptide with a formylated N-terminus, derived from the protein sequence of the Wnt-5a protein. Low/no expression levels of Wnt-5 protein in primary tumour cells have been correlated to high risk of recurrent metastatic disease and shortened survival in several different types of cancer patients, including colon cancer.
Current standard therapy involves surgical removal of the tumour followed by 6 months treatment with chemotherapy (FOLFOX). Foxy-5 is expected to decrease migration of cancer cells, in subjects with low/absent levels of Wnt-5a protein in their primary tumour and hence result in lower recurrence and a better overall survival. The trial intends to establish the safety and tolerability of Foxy-5 and to evaluate early signs of anti-metastatic activity in subjects with resectable colon cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two-arm study, 1 to 1 randomization: treatment group and standard therapy
| Arm | Type | Receives |
|---|---|---|
| Foxy-5 | Experimental | Drug: Foxy-5, Drug: FOLFOX regimen, Procedure: Tumour resection (colon cancer surgery)Arm will receive Foxy-5 as neo-adjuvant therapy prior to surgical removal of tumour and afterwards until initiation of FOLFOX 6 months regimen |
| Standard therapy | Active comparator | Drug: FOLFOX regimen, Procedure: Tumour resection (colon cancer surgery)Surgical removal of tumour followed by 6 months FOLFOX regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Ability to understand and willingness to provide written informed consent before any trial-related activities.
- 18 years of age or older.
- Male or female subjects with adenocarcinoma of the colon, judged by CT or MRI as either one of the following stages per TNM classification of colon cancer (8th edition, 2017):
- T1-4, N1-2, M0 or T4, N0, M0 and who are considered to fulfil the local criteria for adjuvant post- operative chemotherapy after scheduled surgery.
- Scheduling of surgery according to local practice allows at least 9 pre- surgery administrations of Foxy-5 for the subject. (Please note: surgery should not be postponed for trial purposes.)
Key exclusion criteria (12 listed)
- Assessed as not suitable or unable to tolerate adjuvant chemotherapy.
- Evidence of distant metastatic (M1) disease at Screening (N1-2 is allowed).
- Any surgery (except tumour biopsy) or therapy with immune suppressive agents or bone marrow stimulating factors within the last two weeks prior to randomization.
- Any active infection requiring IV antibiotic treatment at the time of screening.
- History of hematologic or primary solid tumour malignancy.
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-5Lyophilized powder for solution for intravenous infusion | Drug | Foxy-5 |
| FOLFOX regimen6 months treatment regimen | Drug | Foxy-5, Standard therapy |
| Tumour resection (colon cancer surgery)Surgical removal of patients colon cancer | Procedure or surgery | Foxy-5, Standard therapy |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From date of randomization until 28 days after the last dose of Foxy-5, assessed up to 120 days
The incidence of adverse events (AEs) related to Foxy-5 administration of Grade 3 and higher according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) and the Clavien-Dindo classification of surgical complications. cancer.
ctDNA as surrogate marker for disease free period
Time frame: 2 years after resection of colon cancer
The level of ctDNA in plasma of subjects with Wnt-5a low colon cancer as a surrogate parameter for disease recurrence in subjects with Wnt-5a low colon cancer treated with Foxy-5 compared to subjects with Wnt-5a low colon cancer who are in the Control Arm.
4 secondary outcomes
Overall survival
Time frame: 2 years after resection of tumour
Disease-Free Survival
Time frame: 2 years after resection of tumour
Recurrence-Free Interval
Time frame: study start to 2 years after resection of tumour
ctDNA in Wnt-5a high patients
Time frame: 2 years after resection of tumour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
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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.
Ramon Salazar, MD principal investigator
Institut Català d'Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Foxy-5, FOLFOX regimen and Tumour resection (colon cancer surgery) in people with Colon Cancer, run by WntResearch AB at 1 site in Spain.
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 15 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 9 Dec 2022. 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 Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: From date of randomization until 28 days after the last dose of Foxy-5, assessed up to 120 days). The study lists 2 primary outcomes in all. 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 9 Dec 2022.