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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05949424
Other study ID # 16800
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date May 2024
Est. completion date March 2025

Study information

Verified date November 2023
Source University Medical Center Groningen
Contact Esther Broekman, MD
Phone +31 50 361 0841
Email k.e.broekman@umcg.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
12 weeks
Secondary 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 12 weeks
Secondary 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 up to 60 months
Secondary Overall survival From date of randomization until the date of death from any cause, assessed up to 60 months up to 60 months
Secondary Quality of life measured by QLQ-C30 (general) and QLQ-ELD14 (elderly cancer patients) 12 weeks
Secondary Safety Adverse events, measured by CTCAE v5.0 12 weeks
Secondary Hospital care use number of outpatients visits, telephone contacts or hospital admission days 12 weeks
Secondary Pharmacokinetic parameters: Cmax Peak Plasma Concentration (Cmax) 12 weeks
Secondary Pharmacokinetic parameters: AUC Area under the plasma concentration versus time curve (AUC) 12 weeks
Secondary Pharmacokinetic parameters: Ctrough Trough Plasma Concentration (Ctrough) 12 weeks
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