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Foxy-5 as Neo-Adjuvant Therapy in Subjects With Wnt-5a Low Colon Cancer (NeoFox)

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ClinicalTrials.gov Identifier: NCT03883802
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : April 25, 2019
Sponsor:
Collaborators:
SMS-Oncology BV
SAGA diagnostics AB
Unilabs A/S
BioVica AB
Catalan Institute of Oncology
Information provided by (Responsible Party):
WntResearch AB

Tracking Information
First Submitted Date  ICMJE December 26, 2018
First Posted Date  ICMJE March 21, 2019
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE April 12, 2019
Estimated Primary Completion Date March 14, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03883802 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • Overall survival [ Time Frame: 2 years after resection of tumour ]
    OS at 2 years after resection of the colon cancer
  • Disease-Free Survival [ Time Frame: 2 years after resection of tumour ]
    DFS at 2 years after resection of the colon cancer
  • Recurrence-Free Interval [ Time Frame: study start to 2 years after resection of tumour ]
    Recurrence-free interval (RFI) defined as the time from randomization to tumour recurrence.
  • ctDNA in Wnt-5a high patients [ Time Frame: 2 years after resection of tumour ]
    The level of ctDNA in plasma of subjects with Wnt-5a high colon cancer.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 20, 2019)
Thymidine Kinase activity [ Time Frame: 1 year after resection of tumour ]
The level of thymidine kinase activity in serum in relationship to Wnt- 5a expression in the tumour.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Foxy-5 as Neo-Adjuvant Therapy in Subjects With Wnt-5a Low Colon Cancer
Official Title  ICMJE A Randomized, Multicentre, Open-Label Controlled Phase II Trial of Foxy-5 as Neo-Adjuvant Therapy in Subjects With Wnt-5a Low Colon Cancer
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
two-arm study, 1 to 1 randomization: treatment group and standard therapy
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE
  • Drug: Foxy-5
    Lyophilized powder for solution for intravenous infusion
  • Drug: FOLFOX regimen
    6 months treatment regimen
  • Procedure: Tumour resection (colon cancer surgery)
    Surgical removal of patients colon cancer
Study Arms  ICMJE
  • Experimental: 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
    Interventions:
    • Drug: Foxy-5
    • Drug: FOLFOX regimen
    • Procedure: Tumour resection (colon cancer surgery)
  • Active Comparator: Standard therapy
    Surgical removal of tumour followed by 6 months FOLFOX regimen
    Interventions:
    • Drug: FOLFOX regimen
    • Procedure: Tumour resection (colon cancer surgery)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 14, 2022
Estimated Primary Completion Date March 14, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Ability to understand and willingness to provide written informed consent before any trial-related activities.
  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:

  1. Assessed as not suitable or unable to tolerate adjuvant chemotherapy.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Esther Met +31 20 4350580 E.Met@sms-oncology.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03883802
Other Study ID Numbers  ICMJE SMS-0472B
2018-003074-27 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party WntResearch AB
Study Sponsor  ICMJE WntResearch AB
Collaborators  ICMJE
  • SMS-Oncology BV
  • SAGA diagnostics AB
  • Unilabs A/S
  • BioVica AB
  • Catalan Institute of Oncology
Investigators  ICMJE
Principal Investigator: Ramon Salazar, MD Catalan Institute of Oncology
PRS Account WntResearch AB
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP