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Investigational New Drugs

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https://www.readbyqxmd.com/read/28631098/urolithins-impair-cell-proliferation-arrest-the-cell-cycle-and-induce-apoptosis-in-umuc3-bladder-cancer-cells
#1
Joana Liberal, Anália Carmo, Célia Gomes, Maria Teresa Cruz, Maria Teresa Batista
Ellagitannins have been gaining attention as potential anticancer molecules. However, the low bioavailability of ellagitannins and their extensive metabolization in the gastrointestinal tract into ellagic acid and urolithins suggest that the health benefits of consuming ellagitannins rely on the direct effects of their metabolites. Recently, chemopreventive and chemotherapeutic activities were ascribed to urolithins. Nonetheless, there is still a need to screen and evaluate the selectivity of these molecules and to elucidate their cellular mechanisms of action...
June 20, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28631097/phase-ii-study-of-amrubicin-monotherapy-in-elderly-or-poor-risk-patients-with-extensive-disease-of-small-cell-lung-cancer
#2
Satoshi Igawa, Sakiko Otani, Shinichiro Ryuge, Tomoya Fukui, Yoshiro Nakahara, Yasuhiro Hiyoshi, Mikiko Ishihara, Seiichiro Kusuhara, Shinya Harada, Hisashi Mitsufuji, Masaru Kubota, Jiichiro Sasaki, Noriyuki Masuda
Background Previous study indicated that an optional anti-cancer drug for the treatment of small-cell lung cancer (SCLC) is amrubicin. However, no prospective studies have evaluated amrubicin in chemo-naive elderly or poor-risk patients with SCLC. Therefore, this study aimed to evaluate the efficacy of amrubicin as first-line chemotherapy for elderly or poor-risk patients with extensive-disease SCLC (ES-SCLC). Methods Patients with chemotherapy-naive ES-SCLC received multiple cycles of 40 mg/m(2) amrubicin for 3 consecutive days every 21 days...
June 20, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28631096/a-case-of-nivolumab-related-cholangitis-and-literature-review-how-to-look-for-the-right-tools-for-a-correct-diagnosis-of-this-rare-immune-related-adverse-event
#3
Francesco Gelsomino, Giovanni Vitale, Andrea Ardizzoni
Anti-programmed cell death-1 (PD-1) monoclonal antibodies, such as nivolumab, used for the treatment of several tumors, can trigger effector T-cells against tumor- and self-antigens, leading to the occurrence of different immune-related adverse events. Among them, liver injuries are rare and usually transient. To date, only four cases of immune-related cholangitis in non-small cell lung cancer (NSCLC) patients have been described during nivolumab treatment. Here, we describe laboratory tests, imaging and liver biopsy features that confirm this diagnosis as opposed to other forms of autoimmune liver disease; nevertheless, we also provide evidence of the presence of different clinical-pathological patterns of immune-related cholangitis...
June 20, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28631095/decorin-gene-upregulation-mediated-by-an-adeno-associated-virus-vector-increases-intratumoral-uptake-of-nab-paclitaxel-in-neuroblastoma-via-inhibition-of-stabilin-1
#4
Zijun Zhen, Kaibin Yang, Litong Ye, Zhiyao You, Rirong Chen, Ying Liu
The availability of effective medication for the treatment of refractory or recurrent neuroblastoma remains limited. This study sought to investigate the effects of increased decorin (DCN) expression on the intratumoral uptake of nab-paclitaxel as a potential novel approach to NB. Correlation between the clinical characteristics of neuroblastoma and the expression of DCN, secreted protein acidic and rich in cysteine (SPARC) and stabilin-1 was evaluated. The anticancer effect of recombinant adeno-associated virus-DCN (rAAV-DCN) was assessed in vivo and in vitro...
June 20, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28616837/a-phase-ib-study-of-everolimus-combined-with-metformin-for-patients-with-advanced-cancer
#5
Remco J Molenaar, Tim van de Venne, Mariëtte J Weterman, Ron A Mathot, Heinz-Josef Klümpen, Dick J Richel, Johanna W Wilmink
Background The efficacy to monotherapy with the mTOR inhibitor everolimus in advanced cancer is often limited due to therapy resistance. Combining everolimus with metformin may decrease the chance of therapy resistance. Methods Patients received everolimus and metformin in a 3 + 3 dose-escalation scheme. Objectives were to determine the dose-limiting toxicities (DLTs), maximum tolerated dose, toxic effects, pharmacokinetics and anti-tumour efficacy. Results 9 patients received study treatment for a median duration of 48 days (range: 4-78)...
June 15, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28601918/osimertinib-reactivated-immune-related-colitis-after-treatment-with-anti-pd1-antibody-for-non-small-cell-lung-cancer
#6
Tomoyoshi Takenaka, Koji Yamazaki, Naoko Miura, Naohiko Harada, Sadanori Takeo
We reported a case of relapsing immune-related colitis (initially caused by nivolumab) following osimertinib therapy for lung adenocarcinoma. A 45-year-old female who had never smoked was diagnosed with adenocarcinoma of the lung and underwent surgical resection. Four years after surgical resection, she was diagnosed with recurrent disease and was eventually treated with nivolumab as third-line therapy. One month after the completion of nivolumab therapy, the patient reported abdominal pain and frequent diarrhea...
June 10, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28597151/outcomes-and-prognostic-factors-for-relapsed-or-refractory-lymphoma-patients-in-phase-i-clinical-trials
#7
Jean-Marie Michot, Lina Benajiba, Laura Faivre, Capucine Baldini, Lelia Haddag, Clement Bonnet, Christophe Massard, Frederic Bigot, Camille Bigenwald, Benjamin Verret, Zoé A P Thomas, Andrea Varga, Anas Gazzah, Antoine Hollebecque, David Ghez, Julien Lazarovici, Rastilav Balheda, Aurore Jeanson, Sophie Postel-Vinay, Alina Danu, Jean-Charles Soria, Xavier Paoletti, Vincent Ribrag
Background Although safety and prognostic factors for overall survival (OS) have been extensively studied in Phase I clinical trials on patients with solid tumours, data on lymphoma trials are scarce. Here, we investigated safety, outcomes and prognostic factors in relapsed or refractory lymphoma patients included in a series of Phase I trials. Method and patients All consecutive adult patients with recurrent/refractory lymphoma enrolled in 26 Phase I trials at a single cancer centre in France between January 2008 and June 2016 were retrospectively assessed...
June 9, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28597150/erratum-to-sarcopenic-overweight-is-associated-with-early-acute-limiting-toxicity-of-anti-pd1-checkpoint-inhibitors-in-melanoma-patients
#8
Valentine Heidelberger, François Goldwasser, Nora Kramkimel, Anne Jouinot, Olivier Huillard, Pascaline Boudou-Rouquette, Johan Chanal, Jennifer Arrondeau, Nathalie Franck, Jérôme Alexandre, Benoît Blanchet, Karen Leroy, Marie-Françoise Avril, Nicolas Dupin, Sélim Aractingi
No abstract text is available yet for this article.
June 9, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28569347/clinical-parameters-associated-with-anti-programmed-death-1-pd-1-inhibitors-induced-tumor-response-in-melanoma-patients
#9
Valentine Heidelberger, François Goldwasser, Nora Kramkimel, Anne Jouinot, Nathalie Franck, Jennifer Arrondeau, Sarah Guégan, Audrey Mansuet-Lupo, Jérôme Alexandre, Diane Damotte, Marie-Françoise Avril, Nicolas Dupin, Sélim Aractingi
Background The identification of the melanoma patients sensitive to anti-PD-1 inhibitors, nivolumab or pembrolizumab, is a major therapeutic challenge and an urgent need. We hypothesized that the natural history of the disease might partly reflect the immune state of the patients. Methods We analyzed our cohort of melanoma patients treated with anti-PD-1 from August 2014 to January 2016 in our institution. Objective response was defined as a complete or partial response according to v1.1 RECIST criteria. Results Among 63 metastatic melanoma patients, the overall response rate was 43%...
May 31, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28527133/a-phase-ii-study-of-antibody-drug-conjugate-tak-264-mln0264-in-previously-treated-patients-with-advanced-or-metastatic-pancreatic-adenocarcinoma-expressing-guanylyl-cyclase-c
#10
Khaldoun Almhanna, David Wright, Teresa Macarulla Mercade, Jean-Luc Van Laethem, Antonio Cubillo Gracian, Carmen Guillen-Ponce, Jason Faris, Carolina Muriel Lopez, Richard A Hubner, Johanna Bendell, Alain Bols, Jaime Feliu, Naureen Starling, Peter Enzinger, Devalingham Mahalingham, Wells Messersmith, Huyuan Yang, Adedigbo Fasanmade, Hadi Danaee, Thea Kalebic
Background This phase II open-label, multicenter study evaluated the efficacy, safety, and tolerability of TAK-264 in previously treated patients with advanced or metastatic pancreatic adenocarcinoma expressing guanylyl cyclase C (GCC). Methods Patients with advanced or metastatic pancreatic adenocarcinoma expressing GCC (H-score ≥ 10) received TAK-264 1.8 mg/kg on day 1 of a 21-day cycle as a 30-min intravenous infusion for up to 1 year or until disease progression or unacceptable toxicity. The primary objective was overall response rate (ORR [complete response + partial response (PR)])...
May 19, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28527132/gankyrin-as-a-potential-therapeutic-target-for-cancer
#11
REVIEW
Chongchong Wang, Li Cheng
Gankyrin is an oncoprotein that plays a central role in the development of cancer. Although researchers have increasingly focused on the relationships of gankyrin with carcinogenesis, metastasis and prognosis of different cancers, the molecular mechanisms are still unclear. In recent years, several interacting partners of gankyrin and cell signaling pathways regulated by gankyrin have been elucidated. In addition, accumulating evidence has indicated the contribution of microRNAs to regulating gankyrin expression in tumor cells...
May 19, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28516360/gilteritinib-a-flt3-axl-inhibitor-shows-antileukemic-activity-in-mouse-models-of-flt3-mutated-acute-myeloid-leukemia
#12
Masamichi Mori, Naoki Kaneko, Yoko Ueno, Masaki Yamada, Ruriko Tanaka, Rika Saito, Itsuro Shimada, Kenichi Mori, Sadao Kuromitsu
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 activation of FLT3 and has been implicated in the pathogenesis of AML. The studies reported here evaluated the ability of a novel FLT3/AXL inhibitor, gilteritinib, to block mutated FLT3 in cellular and animal models of AML...
May 17, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28470558/phase-ii-study-of-lanreotide-autogel-in-japanese-patients-with-unresectable-or-metastatic-well-differentiated-neuroendocrine-tumors
#13
Tetsuhide Ito, Yoshitaka Honma, Susumu Hijioka, Atsushi Kudo, Akira Fukutomi, Akira Nozaki, Yasutoshi Kimura, Fuyuhiko Motoi, Hiroyuki Isayama, Izumi Komoto, Seiichi Hisamatsu, Akihiro Nakajima, Akira Shimatsu
Background Lanreotide is a long-acting somatostatin analog with demonstrated efficacy against enteropancreatic neuroendocrine tumor (NET) in the phase III (CLARINET) study. Materials and Methods In this single-arm study, Japanese patients with grade (G) 1/G2 NET received lanreotide (120 mg/4 weeks) for 48 weeks. Those who completed the study were enrolled in a long-term extension study. The primary endpoint was the clinical benefit rate (CBR) defined as a complete response, partial response (PR), or stable disease (SD) over 24-weeks...
May 3, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28466377/successful-osimertinib-rechallenge-in-a-patient-with-advanced-non-small-cell-lung-cancer-following-osimertinib-induced-interstitial-lung-disease-after-treatment-with-nivolumab
#14
Nobuaki Mamesaya, Hirotsugu Kenmotsu, Toshiaki Takahashi
No abstract text is available yet for this article.
May 2, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28466376/phase-i-study-of-nedaplatin-a-platinum-based-antineoplastic-drug-combined-with-nab-paclitaxel-in-patients-with-advanced-squamous-non-small-cell-lung-cancer
#15
Satoshi Igawa, Sakiko Otani, Yoshiro Nakahara, Shinichiro Ryuge, Yasuhiro Hiyoshi, Tomoya Fukui, Hisashi Mitsufuji, Masaru Kubota, Masato Katagiri, Yuichi Sato, Jiichiro Sasaki, Noriyuki Masuda
Background This study was designed to determine the recommended dose of a combination of nedaplatin (NED) and nab-paclitaxel (nab-PTX) in chemotherapy-naive patients with advanced squamous non-small-cell lung cancer (NSCLC). Methods Patients received escalating doses of NED on day 1 and nab-PTX on days 1, 8, and 15 every 4 weeks by an intravenous infusion for up to six cycles. Results A dose of 100 mg/m(2) NED and 100 mg/m(2) nab-PTX was determined to be the recommended dose for patients with advanced squamous NSCLC...
May 2, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28466375/impressive-and-durable-response-to-nivolumab-in-a-patient-with-metastatic-type-2-papillary-renal-cell-carcinoma-on-label-but-without-evidence
#16
Diego A Adrianzen Herrera, Sarah B Fleisig, Benjamin A Gartrell
Nivolumab is a treatment option for patients with metastatic renal cell carcinoma (RCC) previously treated with targeted antiangiogenic therapy. Papillary renal cell carcinoma (PRCC) comprises 10-15% of RCC cases but non-clear cell subtypes were excluded from the immunotherapy trials. We report the case of a woman with recurrent metastatic PRCC who had an impressive therapeutic response to nivolumab with no significant adverse events. She had previously been treated with sunitinib and pazopanib with no response...
May 2, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28466374/the-outcome-of-sorafenib-monotherapy-on-hepatocellular-carcinoma-with-portal-vein-tumor-thrombosis
#17
Yuan-Hung Kuo, I-Pei Wu, Jing-Houng Wang, Chao-Hung Hung, Kun-Ming Rau, Chien-Hung Chen, Kwong-Ming Kee, Tsung-Hui Hu, Sheng-Nan Lu
Sorafenib is not recommended for advanced hepatocellular carcinoma (HCC) patients with Vp4 (portal invasion at the main trunk) by the Japan Society of Hepatology (JSH) due to a risk of hepatic failure. This study aimed to elucidate the safety and efficacy of sorafenib monotherapy on HCC with macro-vascular invasion (MVI). A total of 415 consecutive advanced HCC patients received sorafenib in our hospital. Patients with only MVI and sorafenib monotherapy were retrospectively enrolled. We enrolled 113 (27.2%) patients, including 56 (49...
May 2, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28424891/a-phase-i-dose-escalation-study-of-selumetinib-in-combination-with-erlotinib-or-temsirolimus-in-patients-with-advanced-solid-tumors
#18
Jeffrey R Infante, Roger B Cohen, Kevin B Kim, Howard A Burris, Gregory Curt, Ugochi Emeribe, Delyth Clemett, Helen K Tomkinson, Patricia M LoRusso
Background Combinations of molecularly targeted agents may provide optimal anti-tumor activity and improve clinical outcomes for patients with advanced cancers. Selumetinib (AZD6244, ARRY-142886) is an oral, potent and highly selective, allosteric inhibitor of MEK1/2, a component of the RAS/RAF/MEK/ERK pathway which is constitutively activated in many cancers. We investigated the safety, tolerability, and pharmacokinetics (PK) of selumetinib in combination with molecularly targeted drugs erlotinib or temsirolimus in patients with advanced solid tumors...
April 19, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28417284/a-phase-i-dose-escalation-study-of-the-safety-and-pharmacokinetics-of-a-tablet-formulation-of-voxtalisib-a-phosphoinositide-3-kinase-inhibitor-in-patients-with-solid-tumors
#19
Janice M Mehnert, Gerald Edelman, Mark Stein, Heather Camisa, Joanne Lager, Jean-François Dedieu, Anne-Frédérique Ghuysen, Jyoti Sharma, Li Liu, Patricia M LoRusso
Background Voxtalisib, a PI3K/mTOR inhibitor, has shown antitumor activity in capsule formulation in patients with solid tumors. This Phase I study assessed safety and pharmacokinetics of voxtalisib administered as immediate-release tablets in patients with solid tumors (NCT01596270). Methods A "3 + 3" dose escalation design was used. Adverse events (AEs), pharmacokinetics (PK), food effect and tumor response were evaluated. Results Thirty-two patients received voxtalisib doses ranging from 50 mg to 70 mg once daily (QD) and 17 patients received voxtalisib doses ranging from 30 mg to 50 mg twice daily (BID), for two 28-day cycles...
April 17, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28417283/bis-anthracycline-wp760-abrogates-melanoma-cell-growth-by-transcription-inhibition-p53-activation-and-igf1r-downregulation
#20
Magdalena Olbryt, Aleksandra Rusin, Izabela Fokt, Anna Habryka, Patrycja Tudrej, Sebastian Student, Aleksander Sochanik, Rafał Zieliński, Waldemar Priebe
Anthracycline chemotherapeutics, e.g. doxorubicin and daunorubicin, are active against a broad spectrum of cancers. Their cytotoxicity is mainly attributed to DNA intercalation, interference with topoisomerase activity, and induction of double-stranded DNA breaks. Since modification of anthracyclines can profoundly affect their pharmacological properties we attempted to elucidate the mechanism of action, and identify possible molecular targets, of bis-anthracycline WP760 which previously demonstrated anti-melanoma activity at low nanomolar concentrations...
April 17, 2017: Investigational New Drugs
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