OMO-1 in Solid Malignancies

Stopped early · Phase 1/Phase 2

Conditions studied: Neoplasms

In brief

This is a modular, first time in patient, open-label, multicentre study of OMO-1, administered orally, alone and in combination with anti-cancer treatments, in patients with locally advanced, unresectable or metastatic solid malignancies.

Key facts

Study ID

NCT03138083

Run by

Octimet Oncology N.V.

People needed

40

Starts

2017-08-08

Expected to finish

2020-05-25

Last updated by the study team

2020-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged at least 18 years
• Provision of signed and dated, written informed consent.
• Histological or cytological confirmation of locally advanced, unresectable or metastatic solid malignancy.
• Performance status: Eastern Co-operative Oncology Group (ECOG) ≤1 and life expectancy ≥3 months.
• Ability to swallow and retain oral medication.
• Adequate organ functions.
• Females of child-bearing potential:
• Must use a highly effective method contraceptive measures during the study and for 1 month after the last dose of OMO 1.
• Must not be breast feeding.
• Must have a negative pregnancy test prior to start of dosing.
• Sexually active male patients must be willing to use barrier contraception

You may not qualify if…

• Patients receiving other cancer therapy, or other investigational product apart from the combination agent(s) described in the relevant combination modules.
• Patients who have received radiotherapy for the primary tumour within 1 week from the screening visit.
• Patients receiving medications predominantly metabolized by CYP2B6.
• Patients receiving cannabinoid substances.
• Patients receiving St John's Wort.
• Patients receiving medications that are known to have potent aldehyde oxidase (AO) inhibitory activity.
• Patients with prior splenectomy.
• Patients testing positive for human immunodeficiency virus (HIV) infection, hepatitis B based on findings of persistent hepatitis B virus surface antigen (HBsAg) or other serology test, hepatitis C virus (HCV) or Epstein-Barr Virus (EBV) infection.
• Patients with current, or a history of uveitis.
• Patients with any known uncontrolled inter-current illness including ongoing or active infections, symptomatic congestive heart failure, conditions that could adversely be affected by hypertension or tachycardia, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with a history or clinical evidence of neoplastic central nervous system (CNS) involvement if not stable for 9 weeks prior to the first dose of study treatment.
• Patients with major and/or planned surgery within 12 weeks of the first dose of study treatment.
• Patients with any known severe allergies (e.g., anaphylaxis) to any active or inactive ingredients in OMO-1.
• Patients with nephrolithiasis.
• Patients with current, or a history of any seizure or seizure disorder. This includes receiving, or having received, seizure threshold-raising medication for the treatment of epilepsy.
• In addition to the main core eligibility criteria, Module specific eligibility criteria include:
• Module 1:
• Patient recruited into the paired biopsy cohorts of Part A must have:
• at least 1 lesion suitable for biopsy.
• tumours that are MET gene amplified and/or mutated.
• had no prior therapy with a selective MET inhibitor.
• Patients recruited into Part B cohorts must have:
• tumours that are MET gene amplified and/or mutated.
• at least one lesion, not previously irradiated, that can be accurately measured at baseline.
• had no prior therapy with a selective MET inhibitor.

Where it is running

• Mary Crowley Cancer Research — Dallas, Texas, United States
• University Hospital Antwerp — Edegem, Belgium
• Institut Bergonie — Bordeaux, France
• Hôpital La Timone — Marseille, France
• lnstitut Gustave Roussy — Villejuif, France
• Erasmus MC — Rotterdam, Netherlands
• UMCU Universitair Medisch Centrum Utrecht — Utrecht, Netherlands
• University College London Hospitals NHS Foundation Trust — London, United Kingdom
• The Christie NHS Foundation Trust — Manchester, United Kingdom
• The Newcastle Upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, United Kingdom
• University of Oxford, Department of Oncology — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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