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NCT Number: NCT06498037

Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.

The primary objective is to evaluate the effect of loading boluses when dose incresaing treatment with SC fentanyl in patients with cancer. The primary endpoint of this study is to prove the non-inferiority of fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient.

Patients will be treated with additional loading boluses and plasma-PK samples will be obtained.

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Key information

Conditions

Cancer Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location status: Recruiting

Location contact

Bram C Agema

CONTACT

[email protected]

+31107040704

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years;
  • Able to understand the written information and able to give informed consent.
  • Current or planned treatment with SC fentanyl for cancer-related pain

Exclusion criteria

  • Pregnancy or/ and breastfeeding
  • Other ways of using fentanyl (sublingual, nasal spray and oromucosal)
  • Liver function CPS B or C
  • The use of strong CYP3A4 inhibitors of inducers [9]
  • Presence of somnolence, respiratory depression or CTCAE grade 2 adverse events.

Treatment and study plan

Fentanyl

Drug

Administration of subcutaneously administered fentanyl loading boluses

Primary outcomes

  1. Primary endpoint of this study is to prove the non-inferiority in fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient using a bioequivalence approach

    Time frame: 48 hours after dose increase

    Using a paired t-test the geometric mean of the ratio of the two fentanyl plasma concentrations will be compared. The 90% confidence interval of the geomteric mean should fall within the range of 80 - 125%.

Secondary outcomes

  1. Investigate the safety of the loading bolus strategy by assessing whether CTCAE grade III or higher occur as a consequence of the fentanyl loading boluses.

    Time frame: up to 48 hours after dose increase

    This will be performed as a descriptive analysis

  2. Describe the course of patient reported pain intensity in the 48 hours following the loading boluses.

    Time frame: up to 48 hours after dose increase

    This will be performed as a descriptive analysis

  3. Accurately assess the rate of fentanyl absorption after SC fentanyl administered as a bolus.

    Time frame: up to 48 hours after dose increase

    The pharmacokinetic data will be imputed into a population pharmacokinetic model that allows to simulate other situations and dosing regimens which will be used to further optimize dosing of subcutaneously administered fentanyl

Study contacts

Contact information is provided by the study sponsor or research team.

Bram C Agema

CONTACT

[email protected]

+31107040704

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Acronym: FERRARI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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