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

NCT ID: NCT05949424

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2025-03-31

Brief Summary

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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

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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

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Renal Cell Carcinoma Ovarian Carcinoma Thyroid Carcinoma Breast Carcinoma Endometrium Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Standard SmPC dosing with dose adjustments for toxicity as per SmPC

Group Type ACTIVE_COMPARATOR

Olaparib

Intervention Type DRUG

Starting dose of 300mg 2dd.

Lenvatinib

Intervention Type DRUG

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

Sunitinib

Intervention Type DRUG

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

Palbociclib

Intervention Type DRUG

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

Pazopanib

Intervention Type DRUG

Starting dose of 800mg 1dd.

Intervention group

Lower starting dose with dose-escalation inversely following the dosing steps from the SmPC every 2 weeks in case of good tolerability

Group Type EXPERIMENTAL

Olaparib

Intervention Type DRUG

Starting dose of 200mg 2dd.

Lenvatinib

Intervention Type DRUG

Starting dose of 10mg 1dd.

Sunitinib

Intervention Type DRUG

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

Palbociclib

Intervention Type DRUG

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

Pazopanib

Intervention Type DRUG

Starting dose of 200mg 1dd.

Interventions

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Olaparib

Starting dose of 200mg 2dd.

Intervention Type DRUG

Lenvatinib

Starting dose of 10mg 1dd.

Intervention Type DRUG

Sunitinib

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

Intervention Type DRUG

Palbociclib

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

Intervention Type DRUG

Pazopanib

Starting dose of 200mg 1dd.

Intervention Type DRUG

Olaparib

Starting dose of 300mg 2dd.

Intervention Type DRUG

Lenvatinib

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

Intervention Type DRUG

Sunitinib

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

Intervention Type DRUG

Palbociclib

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

Intervention Type DRUG

Pazopanib

Starting dose of 800mg 1dd.

Intervention Type DRUG

Other Intervention Names

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Lynparza Lenvima Sutent Ibrance Votrient Lynparza Lenvima Sutent Ibrance Votrient

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esther Broekman, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Esther Broekman, MD

Role: CONTACT

Phone: +31 50 361 0841

Email: [email protected]

Facility Contacts

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Esther Broekman, MD

Role: primary

Other Identifiers

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16800

Identifier Type: -

Identifier Source: org_study_id