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

Sponsor
University Medical Center Groningen
Study ID
NCT05949424
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 31, 2024
Status verified
Nov 2023
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group
    Standard SmPC dosing with dose adjustments for toxicity as per SmPC
  • Experimental: Intervention group
    Lower starting dose with dose-escalation inversely following the dosing steps from the SmPC every 2 weeks in case of good tolerability

Primary Outcome Measure

Feasibility of investigating whether a lower starting dose with step-up approach leads to a better overall treatment utility compared to standard dosing [ Time Frame: 12 weeks ]

Central Contacts

Related Studies