OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study hypothesis is that a lower starting dose of anticancer tablet treatments can lead to better treatment tolerability in older patients, while the benefits of treatment can be the same. The trial population consists of 30 patients aged 65 years or older, who are starting treatment with one of these anti cancer tablet treatments: pazopanib, olaparib, lenvatinib, sunitinib or palbociclib. The control group (half of the participants) will be treated with the standard-of-care, the interventional group will start with the lowest dose of the anti cancer tablets as described in the drug label. The dose will be increased every two weeks in case of good tolerability. Results of this pilot study will be used to inform the design of the larger randomised phase 2 trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: Lenvatinib; Olaparib; Palbociclib; Sunitinib

Criteria

Inclusion Criteria:

• Adult patients ≥ 65 years of age.

• Indication for starting treatment with pazopanib (for renal cell carcinoma), olaparib (for ovarian carcinoma), lenvatinib (as monotherapy for thyroid carcinoma, or in combination with pembrolizumab for renal cell carcinoma or endometrium carcinoma), sunitinib (for renal cell carcinoma) or palbociclib (for breast carcinoma).

• No contra-indications for starting treatment at the recommended starting dose as per SmPC.

• All patients must provide written informed consent prior to enrolment.

Exclusion Criteria:

• Planned starting dose lower than the recommended starting dose as per SmPC

For Pazopanib:

• Use of a strong CYP3A4-inhibitor or PgP-inhibitor

• Creatinine clearance <30ml/min

• Moderate or severe hepatic impairment (bilirubin >1.5x ULN)

For Olaparib:

• Use of a moderate or strong CYP3A4-inhibitor

• Creatinine clearance <50 ml/min

• Severe hepatic impairment (Child-Pugh 10-15)

For Lenvatinib:

• Creatinine clearance <30ml/min

• Severe hepatic impairment (Child-Pugh score 10-15)

For Sunitinib:

• Use of a strong CYP3A4-inhibitor

• Use of a strong CYP3A4-inducer

For Palbociclib:

• Use of a strong CYP3A4-inhibitor

• Severe hepatic impairment (Child-Pugh score 10-15)

• Other findings at interview or physical examination that hamper compliance to the study protocol