CompletedPhase 2

ATREUS - Phase II Study on the Activity of Trabectedin in Patients With Malignant Pleural Mesothelioma (MPM)

Italy145 participantsStarted 2013-07

Plain-language summary

The purpose of this study is to determine whether trabectedin is effective in the treatment of malignant pleural mesothelioma (MPM).

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histologically proven unresectable MPM. In order to make a reproducible diagnosis, in particular regarding biphasic MPM, histology must derive from transthoracic biopsies (at least 3 representative samples) or from videothoracoscopy (at least 5 representative samples)
✓. Age \>18 years
✓. Performance status 0-1 (ECOG)
✓. Measurable disease (CT-PET) according to RECIST criteria modified for malignant pleural mesothelioma
✓. Not more than one previous chemotherapy course (consisting of pemetrexed plus platinum derivative), excluded adjuvant therapy if PFS \< 12 months
✓. A minimum of 3 weeks since previous tumour directed therapy
✓. Recovery from toxic effects of previous therapies to NCI CTC AE Grade 0-1
✓. Patients who have received palliative radiation are eligible if \<30% of bone marrow was irradiated and normal haematological function was completely regained

✕. \- Radiotherapy with curative intent to thoracic wall (concomitant with or prior to chemotherapy)
✕. \- Uncompensated diabetes mellitus or other condition absolutely contra-indicating dexamethasone (used as pre-medication)
✕. \- Patients enrolled in other study with experimental drugs
✕. \- Women of childbearing age/potential
✕. \- Prior exposure to trabectedin
✕. \- History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse
✕. \- Active viral hepatitis or chronic liver disease
✕. \- Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias

Progression Free Survival - PFS12w

Timeframe: 12 weeks

NCT IDNCT02194231

SponsorMario Negri Institute for Pharmacological Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-12

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histologically proven unresectable MPM. In order to make a reproducible diagnosis, in particular regarding biphasic MPM, histology must derive from transthoracic biopsies (at least 3 representative samples) or from videothoracoscopy (at least 5 representative samples)
✓. Age \>18 years
✓. Performance status 0-1 (ECOG)
✓. Measurable disease (CT-PET) according to RECIST criteria modified for malignant pleural mesothelioma
✓. Not more than one previous chemotherapy course (consisting of pemetrexed plus platinum derivative), excluded adjuvant therapy if PFS \< 12 months
✓. A minimum of 3 weeks since previous tumour directed therapy
✓. Recovery from toxic effects of previous therapies to NCI CTC AE Grade 0-1
✓. Patients who have received palliative radiation are eligible if \<30% of bone marrow was irradiated and normal haematological function was completely regained

✕. \- Radiotherapy with curative intent to thoracic wall (concomitant with or prior to chemotherapy)
✕. \- Uncompensated diabetes mellitus or other condition absolutely contra-indicating dexamethasone (used as pre-medication)
✕. \- Patients enrolled in other study with experimental drugs
✕. \- Women of childbearing age/potential
✕. \- Prior exposure to trabectedin
✕. \- History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse
✕. \- Active viral hepatitis or chronic liver disease
✕. \- Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias