OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults
Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Jul 13, 2023
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The OPTI-DOSE clinical trial is researching whether starting older adults on a lower dose of certain oral cancer medications can make treatment easier to tolerate, without losing effectiveness. The study focuses on patients aged 65 and older who are beginning treatment for various types of cancer, including kidney, ovarian, thyroid, breast, and endometrial cancers. Half of the participants will receive the standard starting dose of their medication, while the other half will begin with a lower dose, which may be gradually increased if they handle it well.
To participate in this trial, individuals must be at least 65 years old and be starting treatment with one of the specified medications. They must also have no serious health issues that would prevent them from taking the recommended starting dose of their medication. Before joining, all participants will need to provide written consent. This trial is not yet recruiting participants, but the results will help shape a larger study in the future. If you or a loved one is eligible and interested, this trial could offer a valuable opportunity to help improve cancer treatment for older adults.
Gender
ALL
Eligibility criteria
- 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
About University Medical Center Groningen
University Medical Center Groningen (UMCG) is a leading academic medical center in the Netherlands, renowned for its commitment to innovative research, high-quality patient care, and extensive education in the medical field. As a prominent sponsor of clinical trials, UMCG leverages its multidisciplinary expertise and state-of-the-art facilities to advance medical knowledge and improve therapeutic outcomes. The center fosters collaboration among researchers, healthcare professionals, and industry partners, aiming to translate scientific discoveries into effective treatments that enhance patient health and well-being. With a focus on ethical standards and regulatory compliance, UMCG is dedicated to conducting clinical trials that contribute to the advancement of medicine and the betterment of society.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Groningen, , Netherlands
Patients applied
Trial Officials
Esther Broekman, MD
Principal Investigator
University Medical Center Groningen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported