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

NCT03320525 | Terminated Phase 1 DMC

• 1 other identifier: AA1602
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Keywords

YKL-40; Pharmacokinetic; Solid tumors; T-ChOS; Benecta; chitinase 3 like-1 protein (CHI3L1)

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetic parameters will be assessed for T-ChOS

  • time to reach maximum plasma concentration (tmax)

  Approximately up to 12 months

• Pharmacokinetic parameters will be assessed for T-ChOS

  • area under the plasma concentration-time curve from zero to the last measurable time point (AUC0-t)

  Approximately up to 12 months

• Pharmacokinetic parameters will be assessed for T-ChOS

  • area under the plasma concentration-time curve from zero to infinity (AUC)

  Approximately up to 12 months

• Pharmacokinetic parameters will be assessed for T-ChOS

  • apparent plasma clearance following oral administration (CL/F)

  Approximately up to 12 months

• Pharmacokinetic parameters will be assessed for T-ChOS

  • terminal half-life (t½)

  Approximately up to 12 months

Secondary Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Approximately up to 18 months.

• Overall response rate (ORR)

  Approximately up to 18 months.

• Disease control rate (DCR)

  Approximately up to 18 months.

Other Outcomes (2)

• Serum YKL-40

  Approximately up to 18 months.

• Serum CRP

  Approximately up to 18 months.

Study Arms (1)

Experimental

EXPERIMENTAL

The active substance used in the T-ChOS capsule formulation is a chitooligosaccharide blend.

Dietary Supplement: T-ChOS

Interventions

T-ChOS DIETARY_SUPPLEMENT

T-ChOS 600 mg (two capsules, each 300 mg) daily in the morning 30 minutes before food.

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herlev Hospital: lead
• GENIS: collaborator

Study Sites (1)

Herlev & Gentofte University Hospital, Denmark

Herlev, 2730, Denmark

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open label

Study Record Dates

• First Submitted: October 14, 2017
• First Posted: October 25, 2017
• Study Start: November 29, 2017
• Primary Completion: September 25, 2018
• Study Completion: September 25, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-09

Locations

DK (1)