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Renal Cell CarcinomaPhase 4OPTI-DOSENCT05949424

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

A Phase 4 study testing Olaparib, Lenvatinib and Sunitinib in people with Renal Cell Carcinoma and Ovarian Carcinoma, run by University Medical Center Groningen at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Olaparib, Lenvatinib and Sunitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteNetherlands
Study dates
May 2024to Mar 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Esther Broekman, MD contact

+31 50 361 0841

k.e.broekman@umcg.nl

Netherlands1 site

  • University Medical Center Groningen

    Groningen, 9713 GZ

    Esther Broekman, MD, +31 50 361 0841, k.e.broekman@umcg.nl

    Esther Broekman, MD

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
Olaparib, Lenvatinib, Sunitinib, Palbociclib, Pazopanib
Medical subject headings
Carcinoma, Renal Cell, Ovarian Neoplasms, Thyroid Neoplasms, Breast Neoplasms, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlaparibDrug

    Also called Lynparza

    Starting dose of 200mg 2dd.

  • LenvatinibDrug

    Also called Lenvima

    Starting dose of 10mg 1dd.

  • SunitinibDrug

    Also called Sutent

    Starting dose of 25mg 1dd 28/42 days.

  • PalbociclibDrug

    Also called Ibrance

    Starting dose of 75mg 1dd 21/28 days.

  • PazopanibDrug

    Also called Votrient

    Starting dose of 200mg 1dd.

  • OlaparibDrug

    Also called Lynparza

    Starting dose of 300mg 2dd.

  • LenvatinibDrug

    Also called Lenvima

    Starting dose of 20mg 1dd for RCC or endometrial carcinoma, starting dose of 24mg 1dd for thyroid carcinoma.

  • SunitinibDrug

    Also called Sutent

    Starting dose of 50mg 1dd 28/42 days.

  • PalbociclibDrug

    Also called Ibrance

    Starting dose of 125mg 1dd 21/28 days.

  • PazopanibDrug

    Also called Votrient

    Starting dose of 800mg 1dd.

Study groups in NCT05949424
Study groupRoleWhat they receive
Control groupActive comparatorStandard SmPC dosing with dose adjustments for toxicity as per SmPC
Receives: Drug: Olaparib; Drug: Lenvatinib; Drug: Sunitinib; Drug: Palbociclib; Drug: Pazopanib
Intervention groupExperimentalLower starting dose with dose-escalation inversely following the dosing steps from the SmPC every 2 weeks in case of good tolerability
Receives: Drug: Olaparib; Drug: Lenvatinib; Drug: Sunitinib; Drug: Palbociclib; Drug: Pazopanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of investigating whether a lower starting dose with step-up approach leads to a better overall treatment utility compared to standard dosing

    • The percentage of patients that are willing to participate, from all eligible patients
    • The percentage of patients that successfully complete the first 12 weeks of the trial
    • The percentage of data points that are successfully collected during the first 12 weeks of the trial

    Measured: 12 weeks

Secondary outcomes (9)

  1. Overall treatment utility

    measured by the investigator. See: https://blogs.ed.ac.uk/canceroutcomes/overall-treatment-utility/#:~:text=In%20Oncology%20clinical%20research%2C%20Overall%20Treatment%20Utility%20%28OTU%29,balance%20of%20benefits%20and%20harms%20from%20cancer%20treatments

    Measured: 12 weeks

  2. Progression free survival

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

    Measured: up to 60 months

  3. Overall survival

    From date of randomization until the date of death from any cause, assessed up to 60 months

    Measured: up to 60 months

  4. Quality of life

    measured by QLQ-C30 (general) and QLQ-ELD14 (elderly cancer patients)

    Measured: 12 weeks

  5. Safety

    Adverse events, measured by CTCAE v5.0

    Measured: 12 weeks

  6. Hospital care use

    number of outpatients visits, telephone contacts or hospital admission days

    Measured: 12 weeks

  7. Pharmacokinetic parameters: Cmax

    Peak Plasma Concentration (Cmax)

    Measured: 12 weeks

  8. Pharmacokinetic parameters: AUC

    Area under the plasma concentration versus time curve (AUC)

    Measured: 12 weeks

  9. Pharmacokinetic parameters: Ctrough

    Trough Plasma Concentration (Ctrough)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2023
  2. Study startMay 2024 (estimated)
  3. Primary completionMar 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Control group: standard SmPC dosing. Intervention group: lower starting dose with dose-escalation inversely following the dosing steps from the SmPC every 2 weeks in case of good tolerability.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05949424
Sponsor's protocol ID
16800
Acronym
OPTI-DOSE
Status last verified
Nov 2023
First submitted
19 Jun 2023
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Olaparib, Lenvatinib and Sunitinib in people with Renal Cell Carcinoma and Ovarian Carcinoma, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Esther Broekman, MD (+31 50 361 0841, k.e.broekman@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05949424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.

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