Foxy-5 as Neo-Adjuvant Therapy in Subjects With Wnt-5a Low Colon Cancer
NCT ID: NCT03883802
Last Updated: 2022-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2019-04-12
2024-12-14
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Foxy-5
Arm will receive Foxy-5 as neo-adjuvant therapy prior to surgical removal of tumour and afterwards until initiation of FOLFOX 6 months regimen
Foxy-5
Lyophilized powder for solution for intravenous infusion
FOLFOX regimen
6 months treatment regimen
Tumour resection (colon cancer surgery)
Surgical removal of patients colon cancer
Standard therapy
Surgical removal of tumour followed by 6 months FOLFOX regimen
FOLFOX regimen
6 months treatment regimen
Tumour resection (colon cancer surgery)
Surgical removal of patients colon cancer
Interventions
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Foxy-5
Lyophilized powder for solution for intravenous infusion
FOLFOX regimen
6 months treatment regimen
Tumour resection (colon cancer surgery)
Surgical removal of patients colon cancer
Eligibility Criteria
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Inclusion Criteria
2. 18 years of age or older.
3. 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.
4. 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.)
5. 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.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
7. Clinical laboratory values at screening:
1. Absolute neutrophil count ≥1.5 x 109/L
2. Haemoglobin ≥ 9 g/dL
3. Platelets ≥ 100 x 109/L
4. Aspartate Transaminase (AST) and Alanine Transaminase (ALT)
≤1.5x Upper Limit of Normal (ULN)
5. Serum bilirubin ≤1.5 x the ULN
6. Creatinine clearance \>60 mL/min (determined by Cockcroft-Gault Equation).
Exclusion Criteria
2. Evidence of distant metastatic (M1) disease at Screening (N1-2 is allowed).
3. Any surgery (except tumour biopsy) or therapy with immune suppressive agents or bone marrow stimulating factors within the last two weeks prior to randomization.
4. Any active infection requiring IV antibiotic treatment at the time of screening.
5. History of hematologic or primary solid tumour malignancy.
6. Pregnant or breastfeeding women.
7. Currently participating in another trial and receiving trial therapy or received investigational therapy within 4 weeks of the first dose of Foxy-5.
8. Any other condition or treatment that, in the opinion of the Investigator, might interfere with the trial or current drug or substance abuse.
9. Inability to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial.
10. 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.
11. Legal incapacity or limited legal capacity.
12. Any condition, which results in an undue risk for the subject during the trial participation according to the Investigator.
18 Years
ALL
No
Sponsors
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SMS-Oncology BV
UNKNOWN
SAGA diagnostics AB
UNKNOWN
Unilabs A/S
UNKNOWN
BioVica AB
UNKNOWN
Institut Català d'Oncologia
OTHER
WntResearch AB
INDUSTRY
Responsible Party
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Principal Investigators
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Ramon Salazar, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Català d'Oncologia
Locations
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Instituto de Investigación Sanitaria INCLIVA
Valencia, , Spain
Countries
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Other Identifiers
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2018-003074-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SMS-0472B
Identifier Type: -
Identifier Source: org_study_id