Study to osimertinib treatment in patients with lung cancer.

Phase 1

• Conditions: on-small cell lung carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004290-28-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-26
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients with EGFR-mutated NSCLC receiving standard treatment with osimertinib for at least 2 months, without any signs of disease progression.
2. Stable disease, partial response or complete response on the most-recent tumour-response evaluation.
3. Age = 18 years
4.WHO performance status = 2.
5. Able and willing to give written informed consent.
6. Able and willing to undergo blood sampling for pharmacokinetic analysis.
7. Patients with osimertinib plasma trough concentration below 135 ng/mL. Plasma trough concentration of osimertinib will be determined in another study (METC MUMC: 2018-0800, nWMO).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

1. Any concurrent medication that is known to strongly inhibit or induce CYP3A4. Appendix A shows a list of drugs which are known to strongly inhibit or induce CYP3A4.
2. Any concurrent medication that is primarily metabolised by CYP3A4 with a narrow therapeutic window. Those drugs are also included in appendix A.
3. Impairment of gastrointestinal function that may alter the absorption of osimertiniborcobicistat (e.g. ulcerative disease, uncontrolled nausea or vomiting, malabsorption syndrome, small bowel resection).
4. Refusing to refrain from consuming CYP3A influencing products, e.g. grapefruit(juice), St. John's wort.
5. Pregnancy or breast feeding.
6. Child-Pugh score class C, chronic liver disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to study to what extent cobicistat is able to boost osimertinib exposure when given concurrently in patients who experience low exposure. ;Secondary Objective: The secondary objective is to evaluate the safety profile of cobicistat with osimertinib when given concurrently. ;Primary end point(s): Exposure (AUC) to osimertinib. ;Timepoint(s) of evaluation of this end point: Day 1 (only osimetinib treatment)<br>Day 22 (after three weeks of concurrent cobicistat treatment)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Maximum observed plasma concentration, safety and tolerability. ;Timepoint(s) of evaluation of this end point: Maximum observed plasma concentration: similar to AUC. <br>Safety and tolerability: full study (day 1 - day 22), with patient diary.