Two-stage model-based clinical trial design to optimize phase I development of novel anticancer agents.

abstract：INTRODUCTION:The analysis of predictive factors of response may aid in predicting which patients with advanced renal cell carcinoma (RCC) would be good candidates for systemic treatments. MATERIALS AND METHODS:The expression of several biomarkers was retrospectively analyzed using immunohistochemistry (IHC), as well a...

journal_title：Investigational new drugs

authors： Muriel López C,Esteban E,Astudillo A,Pardo P,Berros JP,Izquierdo M,Crespo G,Fonseca PJ,Sanmamed M,Martínez-Camblor P

更新日期：2012-12-01 00:00:00

abstract：:Chemotherapy has always been the first therapeutic option for patients with advanced non-small cell lung cancer (NSCLC) with untreatable oncogenic mutations. However, chemotherapy has demonstrated limited success and is associated with severe side effects. This research aimed to investigate the antitumor efficacy and ...

journal_title：Investigational new drugs

authors： Han J,Zhao Y,Zhao X,Ma T,Hao T,Liu J,Zhang Z,Zhang J,Wang J

更新日期：2020-08-01 00:00:00

abstract：BACKGROUND:Although its efficacy is unproven, 5-fluorouracil plus cisplatin (FP) is used to prevent postoperative relapse in gastric cancer. We investigated the safety and feasibility of S-1 plus cisplatin (SP) vs. FP for stage IIIB-IV (M0) gastric cancer. METHODS:Following curative resection, 41 stage IIIB-IV (M0) ga...

journal_title：Investigational new drugs

authors： Lee SS,Jeung HC,Chung HC,Noh SH,Hyung WJ,Ahn JY,Rha SY

更新日期：2012-02-01 00:00:00

abstract：:Adrenocortical carcinoma (ACC) is an aggressive endocrine cancer with few molecular predictors of malignancy and survival, especially in paediatric patients. Stathmin 1 (STMN1) regulates microtubule dynamics and has been involved in the malignant phenotype of cancer cells. Recently, it was reported that STMN1 is highl...

journal_title：Investigational new drugs

authors： Dos Santos Passaia B,Lima K,Kremer JL,da Conceição BB,de Paula Mariani BM,da Silva JCL,Zerbini MCN,Fragoso MCBV,Machado-Neto JA,Lotfi CFP

更新日期：2020-06-01 00:00:00

abstract：:To explore the clinical significance of the level of HER2/neu gene amplification in a homogenous cohort of 33 patients with HER2-positive metastatic breast cancer (MBC) and available tumor samples treated with a trastuzumab-based regimen, we retrospectively performed dual-color fluorescence in-situ hybridization test ...

journal_title：Investigational new drugs

authors： Gullo G,Bettio D,Torri V,Masci G,Salvini P,Santoro A

更新日期：2009-04-01 00:00:00

abstract：:Fifteen patients with advanced, cisplatin-refractory germ cell tumors (GCT) were treated with iproplatin (CHIP). No objective responses were noted in any of the patients treated. By restricting the entry criteria to heavily pre-treated patients, the identification of new active agents in phase II trials may be hindere...

journal_title：Investigational new drugs

authors： Murphy BA,Motzer RJ,Bosl GJ

更新日期：1992-11-01 00:00:00

abstract：INTRODUCTION:Continuous efforts from scientists of diverse fields are necessary not only to better understand the mechanism by which multidrug resistant (MDR) cancer cells occur, but also to boost the discovery of new cytotoxic compounds. This work was designed to assess the cytotoxicity and the mechanism of action of ...

journal_title：Investigational new drugs

authors： Kuete V,Sandjo LP,Djeussi DE,Zeino M,Kwamou GM,Ngadjui B,Efferth T

更新日期：2014-12-01 00:00:00

abstract：:Advances in the understanding of the molecular basis for acute myeloid leukemia (AML) have generated new potential targets for treatment. Fms-like tyrosine kinase 3 (FLT3) is one of the most frequently mutated genes in AML and mutations in this gene are associated with poor overall survival. AXL plays a role in the ac...

journal_title：Investigational new drugs

authors： Mori M,Kaneko N,Ueno Y,Yamada M,Tanaka R,Saito R,Shimada I,Mori K,Kuromitsu S

更新日期：2017-10-01 00:00:00

abstract：:Tea (Camellia sinensis) is one of the most widely used beverages worldwide and tea consumption has been shown to have an inverse correlation to the incidence of human cancers in epidemiological and experimental studies. In the present study, the protective effects of green tea polyphenols (GTP) and black tea polypheno...

journal_title：Investigational new drugs

authors： Srivastava S,Singh M,Roy P,Prasad S,George J,Shukla Y

更新日期：2009-12-01 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：:An automated in vitro technique for drug toxicity testing is described. Human tumor cells were cultured for 2 days in 96-well microtiter plates before the addition of serial dilutions of drugs. At day 5 the cultures were terminated by the addition of a solution containing propidium iodide, ink and triton X-100 (PIT). ...

journal_title：Investigational new drugs

authors： van Lambalgen R,Lelieveld P

更新日期：1987-01-01 00:00:00

abstract：:Breast cancer is commonly treated with anti-estrogens or aromatase inhibitors, but resistant disease eventually develops and new therapies for such resistance are of great interest. We have previously isolated several tamoxifen-resistant variant sub-lines of the MCF-7 breast cancer cell line and provided evidence that...

journal_title：Investigational new drugs

authors： Leung E,Rewcastle GW,Joseph WR,Rosengren RJ,Larsen L,Baguley BC

更新日期：2012-12-01 00:00:00

abstract：:Background Treatment of recurrent, unresectable granulosa cell tumor (GCT) of the ovary can be challenging. Given the rarity of the tumor, alternative therapies have been difficult to evaluate in large prospective clinical trials. Currently, to our knowledge, there are no reports of the use of immune checkpoint inhibi...

journal_title：Investigational new drugs

authors： How JA,Jazaeri A,Westin SN,Sood AK,Ramondetta LM,Xu M,Abonofal A,Karp DD,Subbiah V,Stephen B,Rodon JA,Yang F,Naing A

更新日期：2021-01-07 00:00:00

abstract：:BMS-754807 is an inhibitor of insulin-like growth factor-1 receptor (IGF-1R) and insulin receptor that also represses aurora kinase. Cancers that express high levels of IGF-1/IGF-1R are sensitive to BMS-754807; however, it shows limited efficacy in non-small cell lung cancer (NSCLC) in which IGF-1R-driven signals may ...

journal_title：Investigational new drugs

authors： Lee SJ,Kim EJ,Lee HJ,Kim SY,Oh SJ,Ryu JS,Moon DH,Ahn JH,Kim SW

更新日期：2013-06-01 00:00:00

abstract：:Topotecan (NSC 609099) is a camptothecin analogue that demonstrated activity against a variety of human tumors in preclinical studies. A phase II trial was performed with topotecan given to patients with locally advanced or metastatic adenocarcinoma of the stomach. Topotecan was administered IV Bolus over 30 minutes o...

journal_title：Investigational new drugs

authors： Benedetti JK,Burris HA 3rd,Balcerzak SP,Macdonald JS

更新日期：1997-01-01 00:00:00

abstract：:9-Aminocamptothecin (9-AC) is a water-insoluble camptothecin derivative that demonstrated broad activity in pre-clinical studies. In vitro, greater anti-tumor efficacy can be achieved with prolonged administration. A minor response was observed in gastric cancer in a phase I study. We conducted a phase II study of 9-A...

journal_title：Investigational new drugs

authors： Kindler HL,Avadhani A,Wade-Oliver K,Karrison T,Mani S,Vokes EE

更新日期：2004-08-01 00:00:00

abstract：:Background AR-67 is a novel camptothecin analogue at early stages of drug development. The phase 1 clinical trial in cancer patients with solid tumors was completed and a population pharmacokinetic model (POP PK) was developed to facilitate further development of this investigational agent. Methods Pharmacokinetic dat...

journal_title：Investigational new drugs

authors： Tang F,Tsakalozou E,Arnold SM,Ng CM,Leggas M

更新日期：2019-12-01 00:00:00

abstract：:Background The hexapeptide 4A6 (Ac-Thr(tBu)-His(Bzl)-Thr(Bzl)-Nle-Glu(OtBu)-Gly-Bza) was isolated from a peptide library constructed to identify peptide-based transport inhibitors of multidrug resistance (MDR) efflux pumps including P-glycoprotein and Multidrug Resistance-associated Protein 1. 4A6 proved to be a subst...

journal_title：Investigational new drugs

authors： Oerlemans R,Berkers CR,Assaraf YG,Scheffer GL,Peters GJ,Verbrugge SE,Cloos J,Slootstra J,Meloen RH,Shoemaker RH,Dijkmans BAC,Scheper RJ,Ovaa H,Jansen G

更新日期：2018-10-01 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：:Thirty-two patients with advanced epidermoid carcinoma of the esophagus were treated with ifosfamide (1.50 gm/m2 daily x 5 days) with uroprotective mesna in a phase II study. Eighteen patients were previously untreated. Of 28 evaluable patients, two (7%) had partial remissions lasting 2+ and 6+ months. Toxicity was pr...

journal_title：Investigational new drugs

authors： Nanus DM,Kelsen DP,Lipperman R,Eisenberger M

更新日期：1988-09-01 00:00:00

abstract：:Human topoisomerase II (hTopoII) inhibitors are important chemotherapeutic agents in many different settings including treatment of malignant mesothelioma. Topoisomerase poisons, such as etoposide and doxorubicin, function by trapping the DNA-enzyme covalent complex producing DNA strand breaks which can ultimately lea...

journal_title：Investigational new drugs

authors： Raza A,Jacobson BA,Benoit A,Patel MR,Jay-Dixon J,Hiasa H,Ferguson DM,Kratzke RA

更新日期：2012-08-01 00:00:00

abstract：:Twenty-four patients with advanced epidermoid carcinoma of the esophagus were treated with trimetrexate (TMTX), a lipid soluble non-classical antifol. Patients were given TMTX 8 mg/m2 intravenously day 1-5 every 28 days. In nine of these patients the dose was escalated to 12 mg/m2 day 1-5 every 28 days. Three patients...

journal_title：Investigational new drugs

authors： Alberts AS,Falkson G,Badata M,Terblanche AP,Schmid EU

更新日期：1988-12-01 00:00:00

abstract：:Nafazatrom was tested against a variety of human malignancies with the human tumor stem cell assay at one or more of the following concentrations: 1, 10, 25, and 100 micrograms/ml X 1 h or 0.05, 0.5, or 5 micrograms/ml by continuous exposure. Major (greater than or equal to 70%) inhibition was noted in 7/52 adenocarci...

journal_title：Investigational new drugs

authors： Haas CD,Kyle GW,Crissman JD,Schaldenbrand MF

更新日期：1984-01-01 00:00:00

abstract：:Imidazolium-trans-dimethylsulfoxideimidazoletetrachlororuthenate (NAMI-A) is a ruthenium compound effective on solid tumor metastases. In this study, we evaluated the effects of different routes of administration of NAMI-A on the distribution to primary tumor, lungs and kidneys in BD2F1 hybrids with Lewis lung carcino...

journal_title：Investigational new drugs

authors： Cocchietto M,Zorzet S,Sorc A,Sava G

更新日期：2003-02-01 00:00:00

abstract：:Polymeric cyclodextrin-based nanoparticles are currently undergoing clinical trials as nanotherapeutics. Using a non-covalent approach, we decorated two cross-linked cyclodextrin polymers of different molecular weights with an RGD peptide derivative to construct a novel carrier for the targeted delivery of doxorubicin...

journal_title：Investigational new drugs

authors： Viale M,Tosto R,Giglio V,Pappalardo G,Oliveri V,Maric I,Mariggiò MA,Vecchio G

更新日期：2019-08-01 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：:Menogaril, a semisynthetic anthracycline antibiotic, was administered to patients with metastatic adenocarcinoma of the prostate. Forty-five patients with measurable disease and 45 patients with evaluable disease received 150-200 mg/m2 over 1 hour every 28 days. There were three partial responses (PR) among 87 patient...

journal_title：Investigational new drugs

authors： Taylor SA,Blumenstein BA,Stephens RL,Crawford ED,Pistone B,Hill JB

更新日期：1994-01-01 00:00:00

abstract：:Mitoxantrone (Novantrone; 1, 4-dihydroxy-5, 8-bis [[2-[(2-hydroxyethyl) amino]ethyl]amino-] 9, 10 anthracenedione dihydrochloride (NSC 301739] is a synthetic anthracenedione with intercalating properties. Activity has been shown in preclinical studies in mice bearing intraperitoneal P388 and L1210 leukaemias, ADJ-Pc6 ...

journal_title：Investigational new drugs

authors： Prentice HG,Wimperis JZ,Robbins G

更新日期：1985-01-01 00:00:00

abstract：:Coptis chinensis Franch. has been extensively used in traditional Chinese medicine. The chemical structure of oxyepiberberine, as an alkaloid isolated from Coptis chinensis Franch., has been previously studied. However, anti-cancer effects and underlying mechanisms of oxyepiberberine need to be explored. This study ai...

journal_title：Investigational new drugs

authors： Ning H,Lu W,Jia Q,Wang J,Yao T,Lv S,Li Y,Wen H

更新日期：2020-09-30 00:00:00

abstract：:We investigated proliferation and apoptosis induction in Jurkat T-leukemia cells by the new isothiocyanate 4-(methylthio)butylisothiocyanate (MTBITC). To help elucidate whether the effects of MTBITC are specific for cancer cells, we tested MTBITC on freshly isolated, non-transformed human peripheral T lymphocytes. The...

journal_title：Investigational new drugs

authors： Fimognari C,Nüsse M,Iori R,Cantelli-Forti G,Hrelia P

更新日期：2004-04-01 00:00:00