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

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Esther Broekman, MD · University Medical Center Groningen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-31

Primary Completion

2025-03-31

Completion

2025-03-31

Countries

• Netherlands

Study Locations