A multicenter phase II study of brigatinib for patients with metastatic solid tumor

JRCT ID: jRCT2041210148

Registered date:18/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ALK-fusion gene-positive advanced/recurrent solid tumors except for non-small cell lung cancer
• Date of first enrollment: 02/05/2022
• Target sample size: 28
• Study type: Interventional

Intervention(s)

Each cycle will consist of 28 days.
Brigatinib is administered orally at a dose of 90 mg once daily for 7 days. Thereafter, the dose is increased to 180 mg orally once daily.

Outcome(s)

• Primary Outcome: Confirmed objective response rate (ORR) by central assessment

Secondary Outcome

- Overall response by investigators; Confirmed objective response rate (ORR) by investigators' assessment
- Progression-free survival; PFS by central assessment and investigators' assessment
- Duration of response; DoR by central assessment and investigators' assessment
- Disease control rate; DCR by by central assessment and investigators' assessment
- Time to treatment failure; TTF
- Overall survival; OS
- Incidence of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Voluntary written consent to participate in the study has been obtained
2) Patients who are 20 years of age or older on the day informed consent is obtained
3) Patients with a histologically confirmed diagnosis of advanced or recurrent solid tumor
4) Patients with advanced or recurrent solid tumors that have become refractory or intolerant to standard therapies, or have no satisfactory standard therapy
5) Patients with solid tumors positive for ALK-fusion genes
6) Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1
7) Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
8) Patients expected to survive for at least 3 months
9) Patients who are able to receive oral administration
10) Patients with adequate organ function as measured by the laboratory tests within 7 days prior to enrollment
11) Patients of childbearing potential must have a negative urine pregnancy test within 14 days prior to enrollment
12) Patients who consented to the use of adequate contraception from the time of signing informed consent to 4 months after the last dose of the investigational product

Exclude criteria

1) Patients previously treated with ALK inhibitors
2) Patients diagnosed with non-small cell lung cancer (NSCLC)
3) Patients with symptomatic brain metastases or meningeal dissemination. However, asymptomatic brain metastases that do not require corticosteroid induction within 1 week of study enrollment or dose escalation can be considered eligible.
4) Patients with meningeal dissemination
5) Patients with clinically significant cardiac disease (requiring treatment)
6) Patients with uncontrolled hypertension
7) Patients with a history of interstitial lung disease or pulmonary fibrosis
8) Patients with malabsorption syndrome or other gastrointestinal diseases that may affect drug absorption
9) Patients who had undergone surgery with general anesthesia within 2 weeks prior to study enrollment
10) Patients who had undergone treatment with chemotherapy, hormone therapy or radiotherapy within 2 weeks prior to study enrollment and monoclonal antibody (molecular-targeted therapy, antibody therapy, immunotherapy) within 4 weeks prior to study enrollment
11) Synchronous or metachronous multiple cancers with a disease-free interval of <= 2 years at the time of enrollment
12) Patients with known human immunodeficiency virus (HIV) infection
13) Patients who are pregnant or breastfeeding
14) Patients taking CYP3A inhibitors or CYP3A inducers within 14 days prior to enrollment
15) Patients with other medically significant abnormalities

Related Information

• Primary Sponsor: Toshiki Masuishi
• Source(s) of Monetary Support: Takeda Pharmaceutical Company Limited