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Status:

TERMINATED

Pharmacokinetic Profile of T-ChOS™ in Subjects With Advanced Solid Tumors (CHITIN)

Lead Sponsor:

Herlev Hospital

Collaborating Sponsors:

GENIS

Conditions:

Advanced Solid Tumors

Eligibility:

All Genders

18-75 years

Phase:

PHASE1

Brief Summary

This is a single center phase 1 trial, which evaluates the pharmacokinetic profile of T-ChOS™ (food supplement Benecta™) in subjects with advanced solid tumors.

Detailed Description

YKL-40 (also named chitinase 3 like-1 protein, CHI3L1), is a member of the mammalian chitinase like proteins and is a highly conserved glycoprotein. YKL-40 is produced by cancer cells and macrophages ...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Signed written Informed Consent
  • Male or females aged 18 to 75 years at the time of signing the informed consent form (ICF)
  • Patients must have histological confirmed malignancy (solid tumor) that is metastatic or unresectable and for which standard curative or palliative therapies do not exist or are no longer effective
  • Understand and voluntarily sign an ICF prior to any study related assessments or procedures being conducted
  • Performance status 0-1 (ECOG)
  • Life expectancy ≥ 3 months
  • Elevated blood YKL-40 \> 40 μg/L, assessed within 28 days prior to the start of the study
  • Hematopoietic
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
  • Platelet count ≥ 100 x 10⁹/L
  • Haemoglobin ≥ 5.6 mmol/L
  • Hepatic
  • Serum bilirubin \< 1.5 x upper limit of normal (ULN)
  • AST/ALT \< 2.5 x ULN (\< 5 x ULN with known liver metastasis)
  • Renal
  • Acceptable renal function with a creatinine clearance ≥ 50 mL/min/ (e.g., using the Cockroft-Gault formula)
  • Cardiovascular
  • No severe or uncontrolled cardiac condition
  • Pulmonary
  • No severe or uncontrolled pulmonary condition
  • Immunologic
  • No known or suspected allergy to the investigational product
  • Gastrointestinal
  • No chronic enteropathy (e.g. active inflammatory bowel disease, extensive intestinal resection or chronic diarrhea)
  • No bowel obstruction or sub-obstruction
  • No prior history of intestinal malabsorption
  • Patients have to be able to swallow normally and have to be willing to comply with the intake of capsules
  • Others
  • No psychiatric condition that would preclude study participation
  • No co-existing active infection requiring antibiotics or any co-existing medical conditions likely to interfere with study procedures
  • No other condition that will preclude study participation
  • A negative pregnancy test for women of childbearing potential. For men and women of child-producing potential, the use of effective contraceptives methods during the study and at least 3 months after discontinuations of the investigational product is required. The following contraceptive methods are regarded as effective: intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release). Sterilised or infertile patients are exempt from the requirement to use contraception. In order to be considered sterilised or infertile, patients must generally have undergone surgical sterilisation (vasectomy/bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be postmenopausal defined as 12 months or more with no menses prior to enrolment
  • Not pregnant or nursing
  • Be able to adhere to the study visit schedule and other protocol requirements
  • EXCLUSION CRITERIA:
  • Simultaneous participation in any other study involving investigational drugs or having participated in a study within 2 weeks prior to start of study treatment
  • Current use of anticoagulation therapy such as heparins both unfractionated and low molecular weighted
  • Symptomatic brain metastases
  • Intake of any prohibited concomitant medication
  • Prior and Concurrent Therapy at least 2 weeks prior to 1st dosing:
  • Biologic/immunotherapy
  • Chemotherapy
  • Radiotherapy
  • Major or laparoscopic surgery
  • Other concurrent anticancer therapy
  • Corticosteroids or other immunosuppressive medications. Inhaled or topical steroids are permitted.

Exclusion

    Key Trial Info

    Start Date :

    November 29 2017

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 25 2018

    Estimated Enrollment :

    11 Patients enrolled

    Trial Details

    Trial ID

    NCT03320525

    Start Date

    November 29 2017

    End Date

    September 25 2018

    Last Update

    October 2 2018

    Active Locations (1)

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    Herlev & Gentofte University Hospital, Denmark

    Herlev, Denmark, 2730