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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04987203 -
Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
|
Phase 3 | |
Recruiting |
NCT06391879 -
Establishment of a Multidimensional Prediction Model for the Natural Course of VHL Disease-related Renal Cell Carcinoma
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Terminated |
NCT03655613 -
APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05418387 -
A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona
|
N/A | |
Recruiting |
NCT04623502 -
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
|
N/A | |
Completed |
NCT02853344 -
Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427)
|
Phase 2 | |
Terminated |
NCT04088500 -
A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma
|
Phase 2 | |
Completed |
NCT05070637 -
Circulating Tumor Cell Reducing No-touch Nephrectomy
|
N/A | |
Active, not recruiting |
NCT03634540 -
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)
|
Phase 2 | |
Not yet recruiting |
NCT06049030 -
A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma
|
Phase 1 | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Completed |
NCT01358721 -
Phase I Biomarker Study (BMS-936558)
|
Phase 1 | |
Active, not recruiting |
NCT04503148 -
Anesthesia and Cancer Study: Renal Cell Carcinoma
|
N/A | |
Completed |
NCT02386826 -
INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme
|
Phase 1 | |
Not yet recruiting |
NCT05808608 -
A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma
|
Phase 1/Phase 2 | |
Withdrawn |
NCT03323710 -
Study of Propranolol Plus Sunitinib in First-line Treatment of Metastatic Renal Cell Carcinoma
|
Phase 2 | |
Completed |
NCT03052504 -
Prospective Versus Retrospective Complications in Radical Cystectomy and Nephrectomy
|