We are analyzing https://link.springer.com/article/10.1007/s00280-010-1410-1.

Title:
A Phase 1 study of UCN-01 in combination with irinotecan in patients with resistant solid tumor malignancies | Cancer Chemotherapy and Pharmacology
Description:
UCN-01 (7-hydroxystaurosporine) is a multi-targeted protein kinase inhibitor that exhibits synergistic activity with DNA-damaging agents in preclinical studies. We conducted a Phase I study to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), pharmacokinetic, and pharmacodynamic effects of UCN-01 and irinotecan in patients with resistant solid tumors. Patients received irinotecan (75–125 mg/m2 IV on days 1, 8, 15, 22) and UCN-01 (50–90 mg/m2 IV on day 2 and 25–45 mg/m2 on day 23 and subsequent doses) every 42 days. Blood for pharmacokinetics of UCN-01 and irinotecan, and blood, normal rectal mucosa, and tumor biopsies for pharmacodynamic studies were obtained. Twenty-five patients enrolled to 5 dose levels. The MTD was irinotecan 125 mg/m2 on days 1, 8, 15, 22 and UCN-01 70 mg/m2 on day 2 and 35 mg/m2 on day 23. DLTs included grade 3 diarrhea/dehydration and dyspnea. UCN-01 had a prolonged half-life and a low clearance rate. There was a significant reduction in SN-38 Cmax and aminopentanocarboxylic acid (APC) and SN-38 glucuronide half-lives. Phosphorylated ribosomal protein S6 was reduced in blood, normal rectal mucosa, and tumor biopsies at 24 h post-UCN-01. Two partial responses were observed in women with ER, PgR, and HER2-negative breast cancers (TBNC). Both tumors were defective for p53. Twelve patients had stable disease (mean duration 18 weeks, range 7–30 weeks). UCN-01 and irinotecan demonstrated acceptable toxicity and target inhibition. Anti-tumor activity was observed and a study of this combination in women with TNBC is underway.
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Keywords {🔍}

ucn, cancer, patients, google, scholar, cas, pubmed, irinotecan, article, dose, tumor, grade, study, day, breast, patient, treatment, protein, cycle, level, kinase, phase, toxicity, mgm, cell, res, days, combination, solid, therapy, tumors, cells, inhibitor, human, table, samples, pharmacokinetic, levels, dna, dlt, observed, tnbc, due, clinical, mtd, chk, prior, hydroxystaurosporine, studies, postucn,

Topics {✒️}

piwnica-worms contributed equally shi-rong cai high-performance liquid chromatography dna double-strand breaks article download pdf double-strand break leading insulin-dependant diabetes mellitus p53-independent clonogenic suppression cyclin-dependent kinase modulators cyclin-dependent kinase inhibitor drug-stabilized cleavable complex absolute neutrophil count triple-negative breast cancer cdc2/cyclin b1 regulation human alpha1-acid glycoprotein p53-dependent mitotic catastrophe dna damage-induced arrest long plasma half-life plasma concentration–time curve preventing ucn-01-mediated abrogation sn-38 glucuronide half-lives ps6/s6 ratio variance piwnica-worms treatment-related toxicity requiring dose escalation schema open access privacy choices/manage cookies p53-based cancer therapies her2-negative breast cancers solid tumor malignancies barnes-jewish hospital full access er+ breast cancer progressed response evaluation criteria resistant solid tumors national cancer institute bauer ks jr s6 ribosomal protein tumor specimens post-treatment single strand break cell signaling technology polymerase chain products high-affinity binding human breast carcinoma cyclin-dependent kinases human glioma cells siteman cancer center undergo mitotic catastrophe drug–drug interactions human epidermoid carcinoma

Questions {❓}

Levesque AA, Eastman A (2007) p53-based cancer therapies: Is defective p53 the Achilles heel of the tumor?

Schema {🗺️}

WebPage:
      mainEntity:
         headline:A Phase 1 study of UCN-01 in combination with irinotecan in patients with resistant solid tumor malignancies
         description:UCN-01 (7-hydroxystaurosporine) is a multi-targeted protein kinase inhibitor that exhibits synergistic activity with DNA-damaging agents in preclinical studies. We conducted a Phase I study to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), pharmacokinetic, and pharmacodynamic effects of UCN-01 and irinotecan in patients with resistant solid tumors. Patients received irinotecan (75–125 mg/m2 IV on days 1, 8, 15, 22) and UCN-01 (50–90 mg/m2 IV on day 2 and 25–45 mg/m2 on day 23 and subsequent doses) every 42 days. Blood for pharmacokinetics of UCN-01 and irinotecan, and blood, normal rectal mucosa, and tumor biopsies for pharmacodynamic studies were obtained. Twenty-five patients enrolled to 5 dose levels. The MTD was irinotecan 125 mg/m2 on days 1, 8, 15, 22 and UCN-01 70 mg/m2 on day 2 and 35 mg/m2 on day 23. DLTs included grade 3 diarrhea/dehydration and dyspnea. UCN-01 had a prolonged half-life and a low clearance rate. There was a significant reduction in SN-38 Cmax and aminopentanocarboxylic acid (APC) and SN-38 glucuronide half-lives. Phosphorylated ribosomal protein S6 was reduced in blood, normal rectal mucosa, and tumor biopsies at 24 h post-UCN-01. Two partial responses were observed in women with ER, PgR, and HER2-negative breast cancers (TBNC). Both tumors were defective for p53. Twelve patients had stable disease (mean duration 18 weeks, range 7–30 weeks). UCN-01 and irinotecan demonstrated acceptable toxicity and target inhibition. Anti-tumor activity was observed and a study of this combination in women with TNBC is underway.
         datePublished:2010-08-08T00:00:00Z
         dateModified:2010-08-08T00:00:00Z
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         pageEnd:1237
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         keywords:
            Phase 1
            Irinotecan
            UCN-01
            Chk1
            Ribosomal protein S6
            Oncology
            Pharmacology/Toxicology
            Cancer Research
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ScholarlyArticle:
      headline:A Phase 1 study of UCN-01 in combination with irinotecan in patients with resistant solid tumor malignancies
      description:UCN-01 (7-hydroxystaurosporine) is a multi-targeted protein kinase inhibitor that exhibits synergistic activity with DNA-damaging agents in preclinical studies. We conducted a Phase I study to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), pharmacokinetic, and pharmacodynamic effects of UCN-01 and irinotecan in patients with resistant solid tumors. Patients received irinotecan (75–125 mg/m2 IV on days 1, 8, 15, 22) and UCN-01 (50–90 mg/m2 IV on day 2 and 25–45 mg/m2 on day 23 and subsequent doses) every 42 days. Blood for pharmacokinetics of UCN-01 and irinotecan, and blood, normal rectal mucosa, and tumor biopsies for pharmacodynamic studies were obtained. Twenty-five patients enrolled to 5 dose levels. The MTD was irinotecan 125 mg/m2 on days 1, 8, 15, 22 and UCN-01 70 mg/m2 on day 2 and 35 mg/m2 on day 23. DLTs included grade 3 diarrhea/dehydration and dyspnea. UCN-01 had a prolonged half-life and a low clearance rate. There was a significant reduction in SN-38 Cmax and aminopentanocarboxylic acid (APC) and SN-38 glucuronide half-lives. Phosphorylated ribosomal protein S6 was reduced in blood, normal rectal mucosa, and tumor biopsies at 24 h post-UCN-01. Two partial responses were observed in women with ER, PgR, and HER2-negative breast cancers (TBNC). Both tumors were defective for p53. Twelve patients had stable disease (mean duration 18 weeks, range 7–30 weeks). UCN-01 and irinotecan demonstrated acceptable toxicity and target inhibition. Anti-tumor activity was observed and a study of this combination in women with TNBC is underway.
      datePublished:2010-08-08T00:00:00Z
      dateModified:2010-08-08T00:00:00Z
      pageStart:1225
      pageEnd:1237
      license:https://creativecommons.org/licenses/by-nc/2.0
      sameAs:https://doi.org/10.1007/s00280-010-1410-1
      keywords:
         Phase 1
         Irinotecan
         UCN-01
         Chk1
         Ribosomal protein S6
         Oncology
         Pharmacology/Toxicology
         Cancer Research
      image:
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         name:Springer-Verlag
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            type:ImageObject
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      author:
            name:Paula M. Fracasso
            affiliation:
                  name:Alvin J. Siteman Cancer Center and Washington University School of Medicine
                  address:
                     name:Department of Internal Medicine, Alvin J. Siteman Cancer Center and Washington University School of Medicine, St. Louis, USA
                     type:PostalAddress
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                  name:University of Virginia
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                     name:Department of Internal Medicine, Alvin J. Siteman Cancer Center and Washington University School of Medicine, St. Louis, USA
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                  name:Alvin J. Siteman Cancer Center and Washington University School of Medicine
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                     name:Department of Internal Medicine, Alvin J. Siteman Cancer Center and Washington University School of Medicine, St. Louis, USA
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