Study on the effects of an OCT2/MATE1 substrate (metformin) and inhibitor (cimetidine) on the exposure of trifluridine/tipiracil (Lonsurf®) in patients with metastatic cancer.

Study on the effects of an OCT2/MATE1 substrate (metformin) and inhibitor (cimetidine) on the exposure of trifluridine/tipiracil (Lonsurf®) in patients with metastatic cancer. - Sumo-study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54985

Enrollment

Registered

2019-08-05

Start date

2019-10-09

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastro-instestinal cancer metastatic gastro-intestinal cancer

Interventions

Lonsurf will be used as standard care of treatment. Lonsurf is given in a dosage of 20-35 mg/m2 b.i.d. Lonsurf will be administered daily at approximately 10.00AM and 10.00PM during day 1-5, day 8-1

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years 2. Patients with a confirmed diagnosis of metastatic cancer with an registered indication for Lonsurf treatment. 3. WHO performance

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating patients 2. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria) 3. Known serious illness or medical unstable conditions that could interfere with this study requiring treatment (e.g. HIV, hepatitis, Varicella zoster or herpes zoster, organ transplants, kidney failure (GFR

Design outcomes

Primary

Measure	Time frame
1. To determine the possible drug interaction between Lonsurf and metformin on Lonsurf plasma pharmacokinetics (AUC) in patients with metastatic cancer. 2. To determine the possible interaction between Lonsurf and cimetidine on Lonsurf plasma pharmacokinetics (AUC) in patients with metastatic cancer.	—

Secondary

Measure	Time frame
1. To determine the possible drug interaction between Lonsurf and metformine on metformin plasma trough concentration in patients with metastatic cancer. 2. Other pharmacokinetic outcomes of both Lonsurf and metformine (i.e. clearance, maximum concentration (Cmax) and time until maximum concentration (tmax)). 3. To evaluate the incidence and severity of side-effects of treatment with Lonsurf in absence and presence of metformin and cimetidine.	—

Measure

Time frame

1. To determine the possible drug interaction between Lonsurf and metformine on metformin plasma trough concentration in patients with metastatic cancer. 2. Other pharmacokinetic outcomes of both Lonsurf and metformine (i.e. clearance, maximum concentration (Cmax) and time until maximum concentration (tmax)). 3. To evaluate the incidence and severity of side-effects of treatment with Lonsurf in absence and presence of metformin and cimetidine.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)