EUCTR2013-000548-25-IT
Active, not recruiting
Phase 1
A Randomized-Controlled Three-arm Phase II Study of Lurbinectedin (PM01183) Alone or In Combination with Gemcitabine and a control arm with Docetaxel as Second-Line Treatment in Unresectable Non-Small Cell Lung Cancer (NSCLC) Patients. - Not applicable
Pharma Mar S.A. Sociedad Unipersonal0 sites120 target enrollmentJuly 1, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- nresectable Non-Small Cell Lung Cancer (NSCLC).
- Sponsor
- Pharma Mar S.A. Sociedad Unipersonal
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Voluntary written IC of the patient obtained before any study\-specific procedure.
- •2\) Histologically or cytologically confirmed unresectable NSCLC.
- •3\) Patients must have failed one prior line of CT\-based therapy for unresectable disease.
- •4\) Age between 18 and 75 years, both inclusive.
- •5\) Measurable disease as defined by RECIST v1\.1\.
- •6\) Eastern Cooperative Oncology Group (ECOG) performance status (PS) \= 1\.
- •7\) Adequate hematological, renal, metabolic and hepatic function:
- •a) Hemoglobin \= 9 g/dl (patients may have received prior red blood cell \[RBC] transfusion up to 48 hours before
- •treatment start, if clinically indicated), absolute neutrophil count (ANC) \= 2\.0 x 109/l, and platelet count \= 100 x 109/l.
- •b) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \= 3\.0 x upper limit of normal (ULN) (\= 5\.0 x ULN if liver metastases are present).
Exclusion Criteria
- •1\) Concomitant diseases/conditions:
- •a) History (within the last year) or presence of unstable angina, myocardial infarction, symptomatic congestive heart failure or asymptomatic with left ventricular ejection fraction (LVEF) \= 50% (assessed by multiple\-gated acquisition scan \[MUGA] or equivalent by ultrasound \[US]) or clinically significant valvular heart disease.
- •b) Patients with dyspnea at rest or requiring any oxygen support within the last four weeks.
- •c) Known infection by human immunodeficiency virus (HIV), including seropositive patients without AIDs.
- •d) Chronically active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •e) Active uncontrolled infection; patients undergoing active antibiotherapy for an ongoing infection must have finished treatment at least one week before treatment start.
- •f) Pleural or pericardial effusions requiring invasive management procedures.
- •g) Known myopathy of any cause.
- •h) Limitation of the patient’s ability to comply with the treatment or to follow\-up the protocol.
- •I) Any other major illness that, in the Investigator’s judgment, will substantially increase the risk associated with the patient’s participation in this study.
Outcomes
Primary Outcomes
Not specified
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