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Trial Title:
OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults
NCT ID:
NCT05949424
Condition:
Renal Cell Carcinoma
Ovarian Carcinoma
Thyroid Carcinoma
Breast Carcinoma
Endometrium Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Breast Neoplasms
Thyroid Neoplasms
Endometrial Neoplasms
Sunitinib
Lenvatinib
Olaparib
Palbociclib
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Control group: standard SmPC dosing. Intervention group: lower starting dose with
dose-escalation inversely following the dosing steps from the SmPC every 2 weeks in case
of good tolerability.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Olaparib
Description:
Starting dose of 200mg 2dd.
Arm group label:
Intervention group
Other name:
Lynparza
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
Starting dose of 10mg 1dd.
Arm group label:
Intervention group
Other name:
Lenvima
Intervention type:
Drug
Intervention name:
Sunitinib
Description:
Starting dose of 25mg 1dd 28/42 days.
Arm group label:
Intervention group
Other name:
Sutent
Intervention type:
Drug
Intervention name:
Palbociclib
Description:
Starting dose of 75mg 1dd 21/28 days.
Arm group label:
Intervention group
Other name:
Ibrance
Intervention type:
Drug
Intervention name:
Pazopanib
Description:
Starting dose of 200mg 1dd.
Arm group label:
Intervention group
Other name:
Votrient
Intervention type:
Drug
Intervention name:
Olaparib
Description:
Starting dose of 300mg 2dd.
Arm group label:
Control group
Other name:
Lynparza
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
Starting dose of 20mg 1dd for RCC or endometrial carcinoma, starting dose of 24mg 1dd for
thyroid carcinoma.
Arm group label:
Control group
Other name:
Lenvima
Intervention type:
Drug
Intervention name:
Sunitinib
Description:
Starting dose of 50mg 1dd 28/42 days.
Arm group label:
Control group
Other name:
Sutent
Intervention type:
Drug
Intervention name:
Palbociclib
Description:
Starting dose of 125mg 1dd 21/28 days.
Arm group label:
Control group
Other name:
Ibrance
Intervention type:
Drug
Intervention name:
Pazopanib
Description:
Starting dose of 800mg 1dd.
Arm group label:
Control group
Other name:
Votrient
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.
Detailed 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.
Criteria for 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
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Contact:
Last name:
Esther Broekman, MD
Phone:
+31 50 361 0841
Email:
k.e.broekman@umcg.nl
Investigator:
Last name:
Esther Broekman, MD
Email:
Principal Investigator
Start date:
May 2024
Completion date:
March 2025
Lead sponsor:
Agency:
University Medical Center Groningen
Agency class:
Other
Source:
University Medical Center Groningen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05949424
