The prospective trial of patient-proposed healthcare services with multiple targeted agent based on gene profiling.

JRCT ID: jRCTs031190104

Registered date:01/10/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Solid Tumor
• Date of first enrollment: 03/10/2019
• Target sample size: 1000
• Study type: Interventional
• Intervention(s): molecular target therapy

Outcome(s)

• Primary Outcome: Response rates based on best overall response up to 16 weeks after treatment initiation in patients with measurable disease in each drug cohort
• Secondary Outcome: Overall survival, progression free survival, disease control rate, adverse event

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who are histologically diagnosed as having solid cancer (including cancer of unknown pri
mary site).
2) Patients with unresectable advanced (metastatic and/or locally advanced) cancer that satisfy one
of following two conditions (the number of prior regimens is not matter).
i) There is no standard systemic therapy.
ii) If the patients are candicate of any standard systemic therapy, the standard therapy was terminated due to ineffectiveness or toxicity
3) Patients of any age. The patients must be able to take medicines as described in package insert.
4) Patients have any lesion which can be detected by the contrasted computed tomography or magnetic resonance imaging within 28 days before registration (the patients without measurable lesion is permitted).
5) Patients have any actionable gene abnormalities detected by the multi-gene panel test. This test needs covered by national health insurance or approved by government as evaluation treatment.
6) Patients have any report to prove the result of discussion on expert panel.
7) Patients have medical record about treatment choice discussed with investigator.
8) The suggested drug is not approved for this patient's disease.
9) Patients are not candidate for clinical trial for drug approval or advanced medical care. However, if there is a justifiable reason, participation will bepermitted.
10) Patients agree with all of following two conditions,
-registration of clinical information to C-CAT and using the information for this study.
-provide patients' clinical information in this study to pharmaceutical companies which provide drugs.
11) Patients have no leptomeningeal metastasis or symptomatic brain metastasis
12) Patients have no pericardial effusion, pleural effusion or ascites which need drainage regularly
13) Patients with ECOG performance status (PS) of 0 or 1. (For the patients younger than 15 years
old who are difficult to be assessed by ECOG, the patients can be assessed using conversion form b
etween ECOG and Karnofsky/Lansky.
14) If patients have received anticancer therapy (chemotherapy, molecular target therapy, immunotherapy, endocrine therapy etc) or surgery as of the registration date (bone modifying agents such as bisphosphonateand denosumab for bone metastasis is permitted).
15) If patients have received radiation therapy or radioisotope therapy as of the registration date
16) Regarding organ function within 14 days before study registration, patients who satisfy following
criteria (the patient should not receive G-CSF treatment),
-Neutrophil count, 1,000/mm3 or more,
-Platelet count, 100,000/mm3 or more,
-AST (GOT) activity, 100 U/L or lower (in patientswith liver metastasis, 150 U/L or lower),
-ALT (GPT) activity, 100 U/L or lower (in patients with liver metastasis, 150 U/L or lower),
-Total bilirubin concentration, 2.0 mg/dL or lower,
-Serum creatinine concentration, 1.5 mg/dL or lower. However, even if the serum creatinine concentration, 1.5 mg/dL or higher, the patient with eGFR, 60ml/min/1.73m2 or higher is eligible.
For patients younger than 15 years old, see the criteria below.
a) AST <= 3 times the upper limit of clinical laboratory standards
b) ALT <= 3 times the upper limit of clinical laboratory standards
c) Total bilirubin <= 1.5 times the upper limit of clinical laboratory standards
d) Creatinine <= 1.5 times the upper limit of clinical laboratory standards
17) Patients who provide written informed consent and are covered by national health insurance.Informed consent must be provided by legal representative if patients are younger than 18 years old.

Exclude criteria

1) Patients who have a mental disorder that affects the informed consent process.
2) Patients who have an active infectious disease requiring systemic treatment.
3) Patients who have active gastrointestinal ulcer.
4) Patients who have the presence or past history of pulmonary fibrosis or radiographic findings with interstitial pneumonia.
5) Diagnostic images reveal any inflammation of lung.
6) Patients who have any of HIV antibody, HTLV-1 antibody, HBs antigen, HCV antibody positive.
7) Patients who are HBs antigen negative and HBs antibody positive, or HBc antibody positive, and HBV-DNA negative.HBV-DNA testing is not mandatory if the patients have hepatitis B vaccination records.
8) Women who are pregnant or the possibility, or breast feeding.
9) Patients who are judged to be inappropriate to participate in this study on the basis of physician's assessment.

Related Information

• Primary Sponsor: Yamamoto Noboru
• Source(s) of Monetary Support: ONO PHARMACEUTICAL CO., LTD.,Otsuka Pharmaceutical Co., Ltd.,Health and Labour Sciences Research Grants,Japan Agency for Medical Research and Development