A Phase 1 study of Fasudil with MAP targeting cancer stem cell.

JRCT ID: jRCTs041220024

Registered date:31/05/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: High grade osteosarcoma
• Date of first enrollment: 31/05/2022
• Target sample size: 18
• Study type: Interventional
• Intervention(s): fasudil hydrochloride hydrate as an IV infusion

Outcome(s)

Primary Outcome

Dose limiting toxicity
Maximum tolerated dose

Secondary Outcome

Adverse events
Objective Response Rate
Progression free survival
Pharmacokinetic parameters

Key inclusion & exclusion criteria

• Age minimum: >= 14age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

1.Stage2A, 2B, 3,4, or recurrent high grade osteosarcoma.
2.14 to 64 years of age.
3.Sex; male or female
4.Performance status(ECOG); 0-1
5.With or without measurable disease.
6.Latest adequate organ function as proved by the following laboratory studies within 14 days prior to registration.
Neutrophil count>=1,500 /mm3
Hemoglobin>=9.0 g/dL
Platelet count>=100,000 /mm3
Total bilirubin<=1.5 mg/dL
AST<=100 U/L
ALT<=100 U/L
SpO2 (room air) >=92%
7.Without symptomatic brain metastases and no spinal metastases requiring surgical treatment.
8.No grade 3 or more superior vena cava syndrome, pericardial effusion, pleural effusion, or ascitic fluid.
9.No surgical history within 28 days prior to registration.
10.Not received palliative palliative radiotherapy for metastasis (including gamma knife radiosurgery for brain metastases) within 14 days prior to registration.
11.For patients of child bearing potential: negative urine test within 14 days prior to registration.
12.Able to take oral medications.
13.Written informed consent obtained from the subject or the legally authorized representative.

Exclude criteria

1.Latest adequate organ function as proved by the following laboratory studies within 14 days prior to registration.
Hemoglobin < 8.0 g/dL
WBC count < 2000 /mm3
Platelet count < 50,000 /mm3
AST/ALT > 5 x ULN
Total bilirubin > 3 x ULN
2.Has received chemotherapy, radiation therapy, or other medical therapies within 2 weeks prior to the first dose of Investigational Product.
3.With active bleeding.
4.History of myocardial infarction, angina unstable, congestive heart failure, cerebrovascular disorder (including transient ischaemic attack), pulmonary embolism, or active thromboembolism
5.Patient with uncontrolled Bronchial asthma.
6.Patient with a personal or family history of intracranial bleeding, known intracerebral aneurysms, Moyamoya disease or intracranial lesion on examinations performed within 7 days before first dose of Investigational Product.
7.Patient with hypotension.
8.Patient with hepatic disorder.
9.Patient with renal disorder.
10.Patient with pleural effusion or ascites.
11.History of Cardiac dysfunction.
12.Patients with serious hypersensitivity to methotrexate, adriamycin and cisplatin.
13.Has undergone thoracotomy or laparotomy within 4 weeks prior to the first dose of Investigational Product.
14.Pregnant, lactating or planning pregnancy.
15.Deemed ineligible as determined by the principal investigator or sub-investigator.

Related Information

• Primary Sponsor: Fujita Nobuyuki