Renal Cell Carcinoma Clinical Trial
— OPTI-DOSEOfficial title:
Optimal Dosing of Oral Anticancer Drugs in Older Adults With Cancer: a Randomized Pilot Study.
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Netherlands,
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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