Phase 2 study of amrubicin in previously treated patients with malignant pleural mesothelioma

Phase 2 study of amrubicin in previously treated patients with malignant pleural mesothelioma - Phase 2 study of amrubicin in previously treated patients with malignant pleural mesothelioma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006381

Enrollment

Registered

2011-09-21

Start date

2011-09-01

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

Malignant pleural mesothelioma

Interventions

Amrubicin 35mg/m2 on day1-3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically proven malignant pleural mesothelioma 2.Patients who were not candidates for curative surgery 3.Previously treated with chemotherapy 4.A life expectancy of 12 weeks or more 5.Measurable by RECST criteria 6.Age: >=20 years old 7.ECOG performance status of 0 or 1 8.Adequate bone marrow, liver and renal functions WBC >4000/mm3, Hb > 9.0g/dl, PLT >100,000/mm3, Total bilirubin < 1.5mg/dl, GOT,GPT < 2x upper normal limit, Serum creatinine &#8804; upper normal limit 9.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Symptomatic pericardial effusion 2.Symptomatic SVC syndrome required emergency radiation 3.Serious medical complications 4.Uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure 5.Uncontrolled diabetes mellitus, hypertension, infection 6.Pulmonary fibrosis detectable on chest X ray films 7.Concomitant malignancy 8.Pregnant or milk-feeding female 9.Symptomatic brain metastasis 10.Other clinical difficulties to this study

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression-free survival Overall survival safety	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026