A5059250789- Lung Cancer Research Studies
- Lung Cancer Treatments and Mutations
- Cancer therapeutics and mechanisms
- Cancer Treatment and Pharmacology
- Peptidase Inhibition and Analysis
- Neuroendocrine Tumor Research Advances
- Sarcoma Diagnosis and Treatment
- HER2/EGFR in Cancer Research
- Toxin Mechanisms and Immunotoxins
- Glycosylation and Glycoproteins Research
- Cancer Genomics and Diagnostics
- Colorectal Cancer Treatments and Studies
- Synthesis and Biological Activity
- Prostate Cancer Treatment and Research
- Neutropenia and Cancer Infections
- PI3K/AKT/mTOR signaling in cancer
- Particle accelerators and beam dynamics
- Health Systems, Economic Evaluations, Quality of Life
- Immune cells in cancer
- Protein Degradation and Inhibitors
- Cancer Mechanisms and Therapy
- Colorectal and Anal Carcinomas
- Biomedical Ethics and Regulation
- PARP inhibition in cancer therapy
- Sphingolipid Metabolism and Signaling
PharmaMar (Spain)
2013-2024
Universitat Autònoma de Barcelona
2014
University of Chicago
2014
Universitat de Barcelona
1998-2001
Bellvitge University Hospital
1998
Lurbinectedin (PM01183) binds covalently to DNA and has broad activity against tumor cell lines. This first-in-human phase I study evaluated dose-limiting toxicities (DLT) defined a II recommended dose for PM01183 as 1-hour intravenous infusion every three weeks (q3wk).Thirty-one patients with advanced solid tumors received escalating doses of following an accelerated titration design.PM01183 was safely escalated over 200-fold, from 0.02 5.0 mg/m(2). Dose doubling utilized, requiring 15 nine...
Lurbinectedin (PM01183) has synergistic antitumor activity when combined with doxorubicin in mice xenografted tumors. This phase I trial determined the recommended dose (RD) of (bolus) and PM01183 (1-h intravenous infusion) on day 1 every 3 weeks (q3wk), obtained preliminary evidence for this combination small-cell lung cancer (SCLC).
This phase II clinical trial evaluated the efficacy, safety and pharmacokinetics of plitidepsin 3.2 mg/m2 administered as a 1-hour intravenous infusion weekly on days 1, 8 15 every 4 weeks in 67 adult patients with relapsed/refractory aggressive non-Hodgkin’s lymphoma. Patients were divided into two cohorts: those non-cutaneous peripheral T-cell lymphoma (n=34) other lymphomas (n=33). Efficacy was using International Working Group criteria (1999). Of 29 evaluable lymphoma, six had response...
Abstract Purpose: Lurbinectedin suppresses the oncogenic transcription factor EWS-FLI1 through relocalization to nucleolus, and delays tumor growth in mice bearing Ewing sarcoma xenografts. On basis of this rationale, lurbinectedin was evaluated patients with relapsed sarcoma. Patients Methods: This open-label, single-arm, Basket phase II trial included a cohort 28 treated adult confirmed sarcoma, measurable disease as per Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1, Eastern...
This phase I–II trial compared plitidepsin 1-h infusion alone or combined with dacarbazine (DTIC) as front-line therapy for advanced melanoma. The recommended dose (RD) plitidepsin/DTIC was defined in the first stage. In second stage, patients were randomised to receive single-agent 3.2 mg m−2 (n=20) on days 1, 8 and 15 every 4 weeks (q4wk) 2.4 q4wk DTIC 800 (n=38). overall response rate 21.4%; all responders had normal serum lactate dehydrogenase (LDH) levels performance status ⩽1 at...
Objectives: To evaluate the antitumor response, time-to-event efficacy endpoints and toxicity of plitidepsin (Aplidin) 5 mg/m2 as a 3-hour intravenous (i.v.) infusion every 2 weeks in patients with unresectable advanced medullary thyroid carcinoma (MTC). Methods: Sixteen MTC disease progression or large tumor burden received plitidepsin. Tumor response time-related parameters were evaluated according to Response Evaluation Criteria Solid Tumors. Secondary marker (calcitonin carcinoembryonic...
Lurbinectedin was approved by FDA and other health regulatory agencies for treating adults with metastatic small cell lung cancer (SCLC) disease progression on or after platinum-based chemotherapy. Safety profile at dose (3.2 mg/m2 every 3 weeks) acceptable manageable in 105 adult SCLC patients from a phase II basket trial. This study analyses safety data several solid tumours treated the lurbinectedin-approved dose.Data were pooled 554 patients: 335 all nine tumour-specific cohorts of trial...
Summary Background A phase I study found remarkable activity and manageable toxicity for doxorubicin (bolus) plus lurbinectedin (1-h intravenous [i.v.] infusion) on Day 1 every three weeks (q3wk) as second-line therapy in relapsed small cell lung cancer (SCLC). An expansion cohort further evaluated this combination. Patients methods Twenty-eight patients with SCLC after no more than one line of cytotoxic-containing chemotherapy were treated: 18 (64%) sensitive disease (chemotherapy-free...
3514 Background: LUR is a novel agent that exerts antitumor activity through inhibition of trans-activated transcription and modulation tumor microenvironment. Preclinical synergism/additivity in combination with IRI has been reported, thus prompting the conduct this clinical trial. Methods: Phase Ib-II trial to evaluate escalating doses on Day (D) 1 plus fixed dose 75 mg/m 2 D1 D8 every 3 weeks (q3w) pts advanced solid tumors (+/- G-CSF, if dose-limiting toxicities [DLTs] were neutropenia)....
Summary Lurbinectedin and paclitaxel showed synergism in preclinical studies have non-completely overlapping toxicity profiles. This phase I trial evaluated a combination of lurbinectedin with/without bevacizumab advanced tumors. was divided into Group A, which weekly (60 or 80 mg) plus (3.0–5.0 mg flat dose [FD] 2.2 mg/m 2 ) every 3 weeks solid tumors; B, (BEV, 15 mg/kg) added to the recommended (RD) defined A epithelial ovarian non-small cell lung cancer (NSCLC). 67 patients (A, n = 55;...
Extensive and complete documentation must be submitted for obtaining a marketing authorization of an investigational medicinal product in the European Union, Japan, or United States.One most critical documents as part Common Technical Document, masterpiece application, is Clinical Study Report, which represents integrated full report efficacy safety data individual study therapeutic diagnostic agent.The content format Report recommended by International Conference on Harmonization...