OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults

NCT05949424 | Unknown Phase 4

• 1 other identifier: 16800
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Carcinoma; Ovarian Carcinoma; Thyroid Carcinoma; Breast Carcinoma; Endometrium Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Overall treatment utility

  12 weeks

• Progression free survival

  up to 60 months

• Overall survival

  up to 60 months

• Quality of life

  12 weeks

• Safety

  12 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

Standard SmPC dosing with dose adjustments for toxicity as per SmPC

Drug: Olaparib; Drug: Lenvatinib; Drug: Sunitinib; Drug: Palbociclib; Drug: Pazopanib

Intervention group

EXPERIMENTAL

Lower starting dose with dose-escalation inversely following the dosing steps from the SmPC every 2 weeks in case of good tolerability

Drug: Olaparib; Drug: Lenvatinib; Drug: Sunitinib; Drug: Palbociclib; Drug: Pazopanib

Interventions

Olaparib DRUG

Starting dose of 200mg 2dd.

Also known as: Lynparza

Intervention group

Lenvatinib DRUG

Starting dose of 10mg 1dd.

Also known as: Lenvima

Intervention group

Sunitinib DRUG

Starting dose of 25mg 1dd 28/42 days.

Also known as: Sutent

Intervention group

Palbociclib DRUG

Starting dose of 75mg 1dd 21/28 days.

Also known as: Ibrance

Intervention group

Pazopanib DRUG

Starting dose of 200mg 1dd.

Also known as: Votrient

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Ovarian Neoplasms; Thyroid Neoplasms; Breast Neoplasms; Endometrial Neoplasms

Interventions

olaparib; lenvatinib; Sunitinib; palbociclib; pazopanib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Head and Neck Neoplasms; Thyroid Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Uterine Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Esther Broekman, MD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther Broekman, MD

CONTACT

+31 50 361 0841; k.e.broekman@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 18, 2023
• Study Start: May 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

NL (1)