Amrubicin at a dose of 45mg/m2 with pegylated granulocyte-colony stimulating factor support in patients with previously treated small-cell lung cancer - A prospective observational study -

Amrubicin at a dose of 45mg/m2 with pegylated granulocyte-colony stimulating factor support in patients with previously treated small-cell lung cancer - A prospective observational study - - Amrubicin 45mg/m2 with pegylated granulocyte-colony stimulating factor support

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000034657

Enrollment

Registered

2018-11-01

Start date

2018-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

small-cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed diagnosis of primary small cell lung cancer (SCLC). 2. Provision of written informed consent prior to any study specific procedures. 3. Male or female, aged at least 20 years. 4. The Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 to 2. 5. It is judged that the patient is possible to survive for 3 months or more from the date of registration. 6. Measurable disease in accordance with RECIST Version 1.1. 7. Main organs function is maintained. 8. The patient has been treated with chemotherapy for SCLC. 9. There is no history of administration of Amrubicin.

Exclusion criteria

Exclusion criteria: 1.Transfusion and administration of hematopoietic factor preparations within 14 days before registration. 2.Serious renal dysfunction, or urine protein 2+ or higher in tests registered within 14 days. 3.Serious drug allergy. 4.Duplicate cancer of active. 5.Infections requiring systemic treatment. 6.Fever above 38 degrees Celsius. 7. Significant electrocardiogram abnormality or clinically problematic heart disease. 8. Severe lung disease. 9. Fresh bleeding from the gastrointestinal tract, intestinal palsy, intestinal obstruction or peptic ulcer. 10. Pleural effusion, ascites and pericardial effusion requiring removal of body cavity fluid by drain. 11. Defective thromboembolism. 12. Symptomatic brain metastasis. 13. Serious psychiatric disorders, central nervous disorders or cerebrovascular disorders. 14. Control poor hypertension or diabetes. 15. Severe bone marrow suppression. 16. Pregnant women, lactating women or women with a positive pregnancy test. A woman without intention to contraception. A woman wishing to become pregnant or breastfeeding. A man who is willing to conceive. 17. Cases the attending physician determines that inappropriate to participate in the test.

Design outcomes

Primary

Measure	Time frame
Overall Response Rate	—

Countries

Japan

Contacts

Public ContactTomohiro Sakamoto

Tottori University Hospital Division of Medical Ontology and Molecular Respirology Tottori University Faculty of Medicine

t-sakamoto@med.tottori-u.ac.jp0859-38-6537

Outcome results