Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma.
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|ClinicalTrials.gov Identifier: NCT03213301|
Recruitment Status : Active, not recruiting
First Posted : July 11, 2017
Last Update Posted : October 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma, Advanced||Drug: Lurbinectedin||Phase 2|
Malignant mesothelioma arises from the mesothelial cells of the pleural, peritoneal or pericardial lining and is often associated with asbestos exposition. There is no cure for most malignant mesotheliomas and the scope of all three major oncological therapeutic procedures (surgery, radiotherapy and chemotherapy) is to reduce/eliminate symptoms as well as to prolong progression free survival (PFS) and/or overall survival (OS). While progressive patients are still in good health able to undertake a second-line treatment, there is no standard treatment for progressive disease.
Lurbinectedin is a novel compound structurally related to trabectedin and with similar mode of action. Pre-clinical data showed a better safety profile than trabectedin. Lurbinectedin has been already tested in different Phase I-II trials showing promising activity in ovarian, pancreatic, breast, small and non-small cell lung cancer as well as in other tumor types, with objective responses averaging 30%, disease stabilization up to 75% and having manageable toxicity. Although lurbinectedin has not been widely tested in mesotheliomas, some mesothelioma patients have been already treated with lurbinectedin where again promising activity has been observed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective 2-stage single-arm open-label multicenter phase II trial.|
|Masking:||None (Open Label)|
|Official Title:||Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma. A Multicenter, Single-arm Phase II Trial|
|Actual Study Start Date :||September 28, 2017|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||March 1, 2022|
Lurbinectedin 3.2 mg/m2 i.v. every 3 weeks (one cycle) until progression, unacceptable toxicity or patient's withdrawal.
3.2 mg/m2 i.v. every 3 weeks
Other Name: PM01183
- Progression free survival (PFS) at 12 weeks [ Time Frame: at 12 weeks ]
PFS at 12 weeks is defined as absence of progression or death due to any cause during 12 weeks (±2 weeks) after registration.
Patients with no tumor assessment at 12 weeks (±2 weeks) will be considered:
- Progressed at 12 weeks, if they have no following tumor assessment within the trial (patient died, refused, started a new treatment or was lost to follow-up) or if they progress at the following tumor assessment after 12 weeks (±2 weeks).
- Progression-free at 12 weeks, if they do not progress at the following tumor assessment after 12 weeks (±2 weeks).
- Progression-free survival (PFS) [ Time Frame: From date of registration until the date of first documented relapse or progression according to the modified RECIST criteria for malignant pleural mesothelioma or date of death from any cause, whichever came first, assessed up to 30 months. ]
PFS is defined as time from registration to one of the following events, whichever occurs first:
- Relapse or progression according to the modified RECIST criteria for malignant pleural mesothelioma
- Death due to any cause Patients not experiencing an event will be censored at the date of last evaluable tumor assessment before starting a subsequent treatment, if any.
- Objective response (OR) [ Time Frame: From date of registration until the date of treatment discontinuation for any cause, assessed up to 30 months. ]
OR is defined as complete response (CR) or partial response (PR) achieved by the patient during trial treatment. Tumor response will be evaluated according to the modified RECIST criteria for malignant pleural mesothelioma.
Patients without any tumor assessment during trial treatment will be regarded as having a non-evaluable response (NE) and shall be considered as failures for this endpoint.
- Disease control (DC) at 12 weeks [ Time Frame: at 12 weeks: From date of registration until 14 weeks after. ]DC is defined as CR, PR or stable disease (SD) for at least 12 weeks achieved by the patient during trial treatment. Tumor response will be evaluated according to the modified RECIST criteria for malignant pleural mesothelioma.
- Overall survival (OS) [ Time Frame: From date of registration until the date of death from any cause, assessed up to 30 months. ]OS is defined as time from registration until death due to any cause. Patients alive or lost to follow-up will be censored at the last date they were known to be alive.
- Time to treatment failure (TTF) [ Time Frame: From date of registration until the date of treatment discontinuation for any cause, assessed up to 30 months. ]
TTF is defined as time from registration until treatment discontinuation due to any reason (unacceptable toxicity, patient refusal, progression, death or any other event that determines the termination of the trial treatment).
Patients not experiencing an event will be censored at the date of their last available assessment or visit.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213301
|A.O. SS. Antonio e Biagio e Cesare Arrigo|
|Alessandria, Italy, 15121|
|Istituto Clinico Humanitas|
|Rozzano, Italy, 20089|
|Baden, Switzerland, 5404|
|IOSI Ospedale Regionale di Bellinzona e Valli|
|Bellinzona, Switzerland, 6500|
|Chur, Switzerland, CH-7000|
|St. Gallen, Switzerland, 8401|
|Thun, Switzerland, 3600|
|Winterthur, Switzerland, CH-8401|
|Study Director:||Yannis Metaxas, MD||Kantonsspital Graubünden, Chur|
|Study Chair:||Roger von Moos, Prof||Kantonsspital Graubünden, Chur|
|Study Chair:||Miklos Pless, MD||Kantonsspital Winterthur KSW|
|Study Chair:||Federica Grosso, MD||SS. Antonio e C. Arrigo Hospital Alessandria (Italy)|