Phase I, dose-escalating study of elisidepsin (Irvalec(®)), a plasma membrane-disrupting marine antitumor agent, in combination with erlotinib in patients with advanced malignant solid tumors.

abstract：:The neurotransmitter serotonin is involved in numerous bodily functions via seven different serotonin receptor subfamilies. Serotonin plays a role in gastrointestinal functions like intestinal secretion or peristalsis and neuropsychiatric events like depression or migraine. One of these subtypes has been found on glio...

journal_title：Investigational new drugs

authors： Sturzu A,Sheikh S,Klose U,Echner H,Kalbacher H,Deeg M,Nägele T,Horger M,Ernemann U,Heckl S

更新日期：2012-12-01 00:00:00

abstract：:Background PF-06840003 is a highly selective indoleamine 2, 3-dioxygenase (IDO1) inhibitor with antitumor effects in preclinical models. This first-in-human phase 1 study evaluated safety, pharmacokinetics/pharmacodynamics, and preliminary efficacy in recurrent malignant glioma to determine the maximum tolerated dose ...

journal_title：Investigational new drugs

authors： Reardon DA,Desjardins A,Rixe O,Cloughesy T,Alekar S,Williams JH,Li R,Taylor CT,Lassman AB

更新日期：2020-12-01 00:00:00

abstract：:Indibulin is a synthetic small molecule which antitumor activity is based upon destabilization of microtubules. The primary study objectives were to determine the impact of fasted and fed condition on pharmacokinetic parameters, as well as the maximum tolerated dose of the oral drinking solution of indibulin administe...

journal_title：Investigational new drugs

authors： Kuppens IE,Witteveen PO,Schot M,Schuessler VM,Daehling A,Beijnen JH,Voest EE,Schellens JH

更新日期：2007-06-01 00:00:00

abstract：:An in vitro assay, which evaluates drug effect on 3H-thymidine incorporation, was used to investigate the absolute and relative activities of cisplatin (DDP), carboplatin (CBDCA) and iproplatin (CHIP) on 317 specimens from untreated tumors, including breast and ovarian cancers and malignant melanomas. Similar activiti...

journal_title：Investigational new drugs

authors： Daidone MG,Silvestrini R,Zaffaroni N,Grignolio E,Landoni F

更新日期：1987-01-01 00:00:00

abstract：:Six patients with incurable malignancies were originally treated with vitamin E, 3200 IU/day for fourteen days, followed by the same dose of vitamin E daily plus LCV (20 mg/m2 i.v. bolus daily x 5) with 5FU (425 mg/m2 i.v. bolus immediately following LCV). The same schedule of LCV and 5FU was repeated 4 weeks later, t...

journal_title：Investigational new drugs

authors： Blanke CD,Stipanov M,Morrow J,Rothenberg M,Chinery R,Shyr Y,Coffey R,Johnson DH,Leach SD,Beauchamp RD

更新日期：2001-01-01 00:00:00

abstract：:Osimertinib is a molecularly targeted agent used to treat non-small cell lung cancer (NSCLC) patients with an epidermal growth factor receptor (EGFR) T790M mutation. However, its efficacy and safety profile when patients have poor performance status (PS) is unknown. Therefore, we conducted an open-label, multi-center,...

journal_title：Investigational new drugs

authors： Nakashima K,Ozawa Y,Daga H,Imai H,Tamiya M,Tokito T,Kawamura T,Akamatsu H,Tsuboguchi Y,Takahashi T,Yamamoto N,Mori K,Murakami H

更新日期：2020-12-01 00:00:00

abstract：:B cell prolymphocytic leukemia (B-PLL) is a rare and aggressive disease that is associated with poor survival. Although initially asymptomatic patients do not require therapy, most patients will progress and inevitably require treatment. More than 50% of patients with B-PLL carry abnormalities in the TP53 tumor suppre...

journal_title：Investigational new drugs

authors： Oka S,Ono K,Nohgawa M

更新日期：2020-10-01 00:00:00

abstract：:Background Overcoming resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs) in patients with KRAS wildtype (WT) metastatic colorectal cancer (mCRC) could help meet the needs of patients with limited treatment options. Methods In this phase 1b study, patients with N/KRAS WT, MET-positi...

journal_title：Investigational new drugs

authors： Delord JP,Argilés G,Fayette J,Wirth L,Kasper S,Siena S,Mesia R,Berardi R,Cervantes A,Dekervel J,Zhao S,Sun Y,Hao HX,Tiedt R,Vicente S,Myers A,Siu LL

更新日期：2020-12-01 00:00:00

abstract：:Herein we describe a series of multifunctional 5-aminolevulinic-acid (ALA) prodrugs for photodynamic dependent and independent cancer therapy (PDT). We studied the cell-death mechanisms in glioblastoma U251 cells treated with four ALA-prodrugs: (1) AlaAcBu, that releases ALA, acetaldehyde, and butyric acid; (2) AlaFaB...

journal_title：Investigational new drugs

authors： Berkovitch-Luria G,Weitman M,Nudelman A,Rephaeli A,Malik Z

更新日期：2012-06-01 00:00:00

abstract：:Echinomycin is a quinoxaline antibiotic that was originally isolated from Streptomyces echinatus. Based on its antitumor activity against two i.p. implanted murine tumors, the B16 melanoma, and the P388 leukemia, it was brought into clinical trials by the National Cancer Institute. Recent studies on its cytotoxic acti...

journal_title：Investigational new drugs

authors： Foster BJ,Clagett-Carr K,Shoemaker DD,Suffness M,Plowman J,Trissel LA,Grieshaber CK,Leyland-Jones B

更新日期：1985-01-01 00:00:00

abstract：:A novel schedule of 5-fluorouracil administration has been developed for biochemical modulation studies. In combination with the pyrimidine synthesis inhibitor PALA, 5-fluorouracil has been given as a 24-hour infusion, repeated weekly: a dose of 2600 mg/m2 is well tolerated. To identify a suitable dose of 5-fluorourac...

journal_title：Investigational new drugs

authors： Haas NB,Hines JB,Hudes GR,Johnston N,Ozols RF,O'Dwyer PJ

更新日期：1993-05-01 00:00:00

abstract：:Mitoxantrone (Novantrone) and prednimustine (Sterecyt) are both active as single agents in the treatment of unfavorable non-Hodgkin lymphoma (UNHL). The efficacy and toxicity of the combination of these agents (NOSTE) was evaluated in 28 patients with advanced histopathologically proven UNHL who were not eligible for ...

journal_title：Investigational new drugs

authors： Landys KE

更新日期：1988-06-01 00:00:00

abstract：:Background Metformin use is associated with reduced cancer risk in epidemiological studies and has preclinical anti-cancer activity in ovarian cancer models. The primary objective of this phase I study was to determine the recommended phase II dose (RP2D) of metformin in combination with carboplatin/paclitaxel in pati...

journal_title：Investigational new drugs

authors： Broekman KE,Hof MAJ,Touw DJ,Gietema JA,Nijman HW,Lefrandt JD,Reyners AKL,Jalving M

更新日期：2020-10-01 00:00:00

abstract：:The population approach has been implemented prospectively in the clinical development of docetaxel (Taxotere). Overall 640 patients were evaluable for the population PK/PD analysis. The PK analysis evidenced significant covariates explaining the inter-patient variability of docetaxel clearance and the PK/PD analysis ...

journal_title：Investigational new drugs

authors： Bruno R,Vivier N,Veyrat-Follet C,Montay G,Rhodes GR

更新日期：2001-05-01 00:00:00

abstract：:Fourteen patients with active chronic lymphocytic leukemia who had failed prior therapy were treated with progressive doses of weekly intravenous colchicine beginning at 2 mg and escalating as high as 7 mg in a single injection. Responses were seen in two of 14, with a lessening of adenopathy and splenomegaly. Toxicit...

journal_title：Investigational new drugs

authors： Weick JK,Livingston RB,Van Slyck EJ

更新日期：1983-01-01 00:00:00

abstract：:The matrix metalloproteinases (MMPs) are a family of at least fifteen secreted and membrane-bound zinc-endopeptidases. Collectively, these enzymes can degrade all of the components of the extracellular matrix, including fibrallar and non-fibrallar collagens, fibronectin, laminin and basement membrane glycoproteins. MM...

journal_title：Investigational new drugs

authors： Wojtowicz-Praga SM,Dickson RB,Hawkins MJ

更新日期：1997-01-01 00:00:00

abstract：:Introduction In preclinical data, the combination therapy with S-1 and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) had a synergistic antitumor effect on non-small cell lung cancer (NSCLC), regardless of the EGFR mutation status. Patients and Methods Patients with previously treated NSCLC an...

journal_title：Investigational new drugs

authors： Nakahara Y,Shimokawa T,Misumi Y,Nogami N,Shinkai T,Seki N,Hosomi Y,Hida N,Okamoto H

更新日期：2020-08-15 00:00:00

abstract：BACKGROUND:Based on reports of the efficacy of docetaxel (T) in STS, we undertook a phase I/II trial to determine the response rate (RR), dose-limiting toxicity (DLT), and maximum tolerated dose (MTD) of addition of T to doxorubicin (A) and ifosfamide (I) in advanced STS. METHODS:Patients with advanced, recurrent, or ...

journal_title：Investigational new drugs

authors： Suppiah R,Wood L,Elson P,Budd GT

更新日期：2006-11-01 00:00:00

abstract：:alpha-Difluoromethylornithine (DFMO) is a known irreversible inhibitor of ornithine decarboxylase (ODC), the rate-limiting enzyme in polyamine biosynthesis. Cyclosporine (CsA) has been reported to inhibit ODC activity in vitro. In the present study, we compared the effects of DFMO and CsA on growth, survival, and poly...

journal_title：Investigational new drugs

authors： Saydjari R,Townsend CM Jr,Barranco SC,Thompson JC

更新日期：1987-01-01 00:00:00

abstract：:As HER2 is a client protein of the molecular chaperone Hsp90, targeting Hsp90 may be beneficial in HER2-positive breast cancer. In this study, the activity of the Hsp90 inhibitor NVP-AUY922 was assessed in HER2 overexpressing breast cancer cell lines, including two cell line models of acquired trastuzumab-resistance. ...

journal_title：Investigational new drugs

authors： Canonici A,Qadir Z,Conlon NT,Collins DM,O'Brien NA,Walsh N,Eustace AJ,O'Donovan N,Crown J

更新日期：2018-08-01 00:00:00

abstract：:4-demethoxydaunorubicin (4-dm DNR), a new analog of daunorubicin, was tested at an every 3-week dose schedule in 63 evaluable patients with various forms of disseminated malignancy. Utilizing the intravenous (i.v.) route of administration, the maximum tolerated dose (MTD) was 15-18 mg/m2; with the oral route the MTD w...

journal_title：Investigational new drugs

authors： Bonfante V,Ferrari L,Villani F,Bonadonna G

更新日期：1983-01-01 00:00:00

abstract：:A phase II trial of 4' Deoxydoxorubicin (DXDX) was conducted in unresectable previously untreated non-small cell lung cancer patients. DXDX was administered every 3 weeks by short intravenous infusion at a starting dose of 30 mg/m2, with dose escalation to 40 mg/m2 toxicity permitting. Four responses, all partial, wer...

journal_title：Investigational new drugs

authors： Rose C,Lad TE,Kilton LJ,Schor J,Rosen ST,Rossof AH,Blough RR,Johnson CM

更新日期：1990-02-01 00:00:00

abstract：:Taxol was administered as a 24-hour continuous infusion at 250 mg/m2 in this Phase II trial in patients with adenocarcinomas of the upper gastrointestinal tract (UGIT). Twenty-five patients were entered between July 1991 and June 1992, twenty-three were eligible and were evaluated for toxicity and twenty-two were asse...

journal_title：Investigational new drugs

authors： Einzig AI,Lipsitz S,Wiernik PH,Benson AB 3rd

更新日期：1995-01-01 00:00:00

abstract：:Major discrepancies concerning risk-benefit assessments and regulatory actions are frequent among regulatory agencies. We explored the differences by scrutinizing a case of gemtuzumab ozogamicin (GO) in patients with acute myeloid leukaemia (AML). Assessment reports of GO were retrieved form the websites of the US Foo...

journal_title：Investigational new drugs

authors： Tanimoto T,Tsubokura M,Mori J,Pietrek M,Ono S,Kami M

更新日期：2013-04-01 00:00:00

abstract：:Colon cancer is the third most malignant neoplasm in the world and it remains today an important cause of death, especially in western countries. In this study, we have evaluated the chemopreventive efficacy of morin on tissue lipid peroxidation and antioxidant status, which are used as biomarkers in 1,2-dimethylhydra...

journal_title：Investigational new drugs

authors： Sreedharan V,Venkatachalam KK,Namasivayam N

更新日期：2009-02-01 00:00:00

abstract：:Standard therapy for advanced or metastatic non-small cell lung cancer (NSCLC) has primarily consisted of traditional cytotoxic chemotherapy, although use of targeted therapies has been approved in specific settings. Antiangiogenic agents represent a promising therapeutic strategy for treatment of advanced NSCLC. Beva...

journal_title：Investigational new drugs

authors： Blumenschein GR Jr

更新日期：2012-08-01 00:00:00

abstract：:We have recently developed a liposomal nanoparticle (LNP) formulation of irinotecan based on loading method that involves formation of a complex between copper and the water soluble camptothecin. The loading methodology developed for irinotecan was evaluated to develop a LNP topotecan formulation (referred to herein a...

journal_title：Investigational new drugs

authors： Patankar NA,Waterhouse D,Strutt D,Anantha M,Bally MB

更新日期：2013-02-01 00:00:00

abstract：:Artemisinin and its derivatives are well known antimalarial drugs, particularly useful after resistance to traditional antimalarial pharmaceuticals has started to occur in Plasmodium falciparum. In recent years, anticancer activity of artemisinin has been reported both in vitro and in vivo. Artemisinin has inhibitory ...

journal_title：Investigational new drugs

authors： Buommino E,Baroni A,Canozo N,Petrazzuolo M,Nicoletti R,Vozza A,Tufano MA

更新日期：2009-10-01 00:00:00

abstract：:Monoclonal antibodies directed against the immune checkpoint protein cytotoxic T-lymphocyte antigen-4 (CTLA-4; CD152) have been investigated in metastatic melanoma and other cancers and have shown promising results. Inhibition of CTLA-4 characteristically induces well-known side effects called "immune-related adverse ...

journal_title：Investigational new drugs

authors： Izzedine H,Gueutin V,Gharbi C,Mateus C,Robert C,Routier E,Thomas M,Baumelou A,Rouvier P

更新日期：2014-08-01 00:00:00

abstract：INTRODUCTION:For decades, determination of the recommended Phase 2 dose (RP2D) was based on the toxicity (especially the maximum tolerated dose or MTD) experienced by patients enrolled in dose-escalating Phase 1 trials investigating anti-cancer agents. Recent studies suggest that this toxicity-based strategy is not sui...

journal_title：Investigational new drugs

authors： Penel N,Duhamel A,Adenis A,Devos P,Isambert N,Clisant S,Bonneterre J

更新日期：2012-04-01 00:00:00