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

NCT03883802 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-12-09

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • SMS-Oncology BV

    collaborator UNKNOWN

  • SAGA diagnostics AB

    collaborator UNKNOWN

  • Unilabs A/S

    collaborator UNKNOWN

  • BioVica AB

    collaborator UNKNOWN

  • Institut Català d'Oncologia

    collaborator OTHER

  • WntResearch AB

    lead INDUSTRY

Principal Investigators

  • Ramon Salazar, MD · Institut Català d'Oncologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-12
Primary Completion
2024-12-14
Completion
2024-12-14

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03883802 on ClinicalTrials.gov