NCT05949424

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

Optimal Dosing of Oral Anticancer Drugs in Older Adults With Cancer: a Randomized Pilot Study.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Information about the benefits and side effects of treatments for cancer is mainly derived from studies with younger patients. It is known that elderly patients experience more side effects from treatments, which can lead to a worse quality of life. 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. This is a randomized study with 1:1 randomisation, stratified by type of anti-cancer treatment. The control group (half of the participants) will be treated with the standard-of-care, that means with the recommended starting dose of the anti cancer tablets as described in the drug label. The dose can be adjusted (lowered) if this is necessary, for example because of side effects, based on the judgment of the treating physician. The interventional group (half of the participants) 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, for example the primary endpoint, the amount of investigations and the size of the study population. Study visits are planned every 2 weeks for a total study duration of 12 weeks, the time point for analysis of the primary endpoint. Blood samples for PK analysis are collected every 2 weeks. A baseline blood sample will be collected for pharmacogenomic analysis.

Conditions

• Renal Cell Carcinoma
• Ovarian Carcinoma
• Thyroid Carcinoma
• Breast Carcinoma
• Endometrium Carcinoma

Interventions

Type	Name	Description
DRUG	Olaparib	Starting dose of 200mg 2dd.
DRUG	Lenvatinib	Starting dose of 10mg 1dd.
DRUG	Sunitinib	Starting dose of 25mg 1dd 28/42 days.
DRUG	Palbociclib	Starting dose of 75mg 1dd 21/28 days.
DRUG	Pazopanib	Starting dose of 200mg 1dd.
DRUG	Olaparib	Starting dose of 300mg 2dd.
DRUG	Lenvatinib	Starting dose of 20mg 1dd for RCC or endometrial carcinoma, starting dose of 24mg 1dd for thyroid carcinoma.
DRUG	Sunitinib	Starting dose of 50mg 1dd 28/42 days.
DRUG	Palbociclib	Starting dose of 125mg 1dd 21/28 days.
DRUG	Pazopanib	Starting dose of 800mg 1dd.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2023-07-18
• Last updated: 2023-11-29

Locations

1 site across 1 country: Netherlands