Clinical trial · Interventional
OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults
Optimal Dosing of Oral Anticancer Drugs in Older Adults With Cancer: a Randomized Pilot Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrium Carcinoma | — | UNRESOLVED | — |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Thyroid Carcinoma | Thyroid Gland Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Olaparib | Drug | Olaparib | ALIAS |
| Palbociclib | Drug | Palbociclib | ALIAS |
| Pazopanib | Drug | Pazopanib | ALIAS |
| Sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Standard SmPC dosing with dose adjustments for toxicity as per SmPC
- interventionNames
- Drug: Olaparib
- Drug: Lenvatinib
- Drug: Sunitinib
- Drug: Palbociclib
- Drug: Pazopanib
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Lower starting dose with dose-escalation inversely following the dosing steps from the SmPC every 2 weeks in case of good tolerability
- interventionNames
- Drug: Olaparib
- Drug: Lenvatinib
- Drug: Sunitinib
- Drug: Palbociclib
- Drug: Pazopanib
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available