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MeSH Review:

Clinical Trials, Phase II

Giugliano, R.P. et al., Seidman, A.D. et al., Gabrielson, E.W. et al., Hesketh, P.J. et al., Finney, R.E. et al., et al.

Somech, Izraeli, J Simon, Zhang, Richon, Ni, Talpur, Duvic, Huckle, LaVallee, Zhan, Johnson, Herbstritt, Swartz, Williams, Hembrough, Green, Pribluda, Hayden, Coats, Kim, Hassman, Blatter, Zhang, Liu, de Jonge, van der Poll, Kesecioglu, Levi, Finney, Nudelman, White, Bursten, Klein, Leer, Wang, Waggoner, Singer, Lewis, Gish, Piper, Panaretou, Millson, Trumana, Mollapour, Pearl, Prodromou, Kufe, Weichselbaum,

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Disease relevance of Clinical Trials, Phase II

PURPOSE: Two phase II clinical trials were performed to determine efficacy and tolerability of paclitaxel (Taxol; Bristol-Myers Squibb Co, Wallingford, CT) and granulocyte colony-stimulating factor ([G-CSF] Neupogen; Amgen, Inc, Thousand Oaks, CA) as second or subsequent therapy for metastatic breast cancer [1].
Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group [2].
One such agent, hydroxyurea, has been shown to be potentially efficacious in phase II clinical trials in patients with sickle cell anemia and awaits testing in a placebo-controlled phase III study [3].
In addition, several novel anti-HBV agents recently evaluated in phase II clinical trials, such as tenofovir, clevudine, telbivudine, pradefovir, and valtorcitabine, appear to be promising agents for the treatment of chronic hepatitis B [4].
Using immunohistochemistry, we found a majority (64%) of human primary lung cancer explants to exhibit high expression of SSAT after treatment with 10 microM N1,N11-bis(ethyl)norspermine, an agent currently undergoing Phase II clinical trials against several important human solid tumors [5].

Psychiatry related information on Clinical Trials, Phase II

Propentofylline in the treatment of vascular dementia and Alzheimer-type dementia: overview of phase I and phase II clinical trials [6].
Xanomeline is a muscarinic receptor agonist currently in phase II clinical trials for the treatment of Alzheimer's disease [7].

High impact information on Clinical Trials, Phase II

Ecteinascidin-743 (ET-743) is a tetrahydroisoquinoline alkaloid isolated from the tunicate Ecteinascidia turbinata currently under phase II clinical trials for its potent anticancer activity [8].
Oral pleconaril treatment of picornavirus-associated viral respiratory illness in adults: efficacy and tolerability in phase II clinical trials [9].
STI571(formerly CGP 57148B), an Abl tyrosine kinase inhibitor, has specific in vitro antileukemic activity against Bcr-Abl-positive cells and is currently in Phase II clinical trials [10].
2ME2 is currently in several Phase I and Phase II clinical trials under the name Panzem [11].
Adriamycin is a widely used anticancer drug, whereas AN-9 is an anticancer agent presently undergoing Phase II clinical trials [12].

Chemical compound and disease context of Clinical Trials, Phase II

Suberoylanilide hydroxamic acid (SAHA), an orally administered inhibitor of histone deacetylases, is currently in phase II clinical trials for cutaneous T cell lymphomas (CTCL), but the mechanism of SAHA action is unknown [13].
Data were obtained from three phase II clinical trials of garenoxacin administered orally as 400 mg once daily for 5 to 10 days for the treatment of community-acquired pneumonia, acute exacerbation of chronic bronchitis, and sinusitis [14].
Lobucavir [1R(1alpha,2beta,3alpha)]-9-[2,3-bis(hydroxymethyl)cyc lobutyl]guanine (LBV) is a novel antiviral agent with activity against ganciclovir-resistant cytomegalovirus (CMV) strains, that is in phase II clinical trials for the treatment of CMV infections [15].
Atevirdine is a nonnucleoside reverse transcriptase inhibitor with in vitro activity against human immunodeficiency virus type 1 and is currently in phase II clinical trials [16].
TBC-1269 (Bimosiamose), a structural mimetic of natural selectin ligands, inhibits P-, E-, and L-selectin in vitro, has anti-inflammatory effects in vivo, and recently underwent phase II clinical trials for childhood asthma and psoriasis [17].

Biological context of Clinical Trials, Phase II

Here, we will describe the structure of the nucleosome, review regulation of gene expression by acetylation of histones and give an update on the current phase I and phase II clinical trials with histone deacetylase inhibitors [18].
Carboxyamido-triazole (CAI) is a cytostatic signal transduction inhibitor currently being tested in phase II clinical trials [19].
OBJECTIVE: Acetyl starch (ACS) is a new synthetic colloid solution for plasma volume expansion and is now undergoing phase II clinical trials [20].
In addition, two phase-II clinical trials assessed the pharmacokinetics and the safety of telmisartan in mild-to-moderate hypertensive patients [21].
PBT-1 (clioquinol), is undergoing phase II clinical trials by Prana Biotechnology Ltd for the potential treatment of Alzheimer's disease [22].

Anatomical context of Clinical Trials, Phase II

This fact, coupled with in vitro investigations showing growth inhibitory or cytotoxic effects of interferon (IFN) on renal cell carcinoma and melanoma cell lines, led to phase II clinical trials with recombinant (r) IFN-alpha 2C and rIFN-gamma [23].

Associations of Clinical Trials, Phase II with chemical compounds

These data indicate that Phase II clinical trials combining radiolabeled antibody therapy with 5-FU-based treatments are warranted [24].
The antitumor acridine derivative 4'-(9-acridinylamino)methanesulfon-m-anisidide (m-AMSA) is at present being evaluated in Phase 2 clinical trials [25].
N-[4-[2-(2-amino-3,4-dihydro-4-oxo-7H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl ]-benzoyl]-L-glutamic acid (LY231514) is a novel pyrrolo[2,3-d]pyrimidine-based antifolate currently undergoing extensive Phase II clinical trials [26].
Acivicin is an investigational amino acid antitumor antibiotic currently being evaluated in Phase II clinical trials [27].
In this report, it has been demonstrated that enhanced phospholipid metabolism through PA in tumor cells can be exploited pharmacologically for development of anticancer agents, such as CT-2584, a cancer chemotherapeutic drug candidate currently in Phase II clinical trials [28].

Gene context of Clinical Trials, Phase II

Recombinant TFPI is currently in phase II clinical trials for severe sepsis [29].
Purine inhibitors of cyclin-dependent kinases (CDK) seem to be a potential anticancer drug candidate as one of the first representatives, roscovitine, is passing Phase II clinical trials for cancer and glomerulonephritis [30].
Though one of these drugs (17-allylaminogeldanamycin, 17-AAG) is now progressing to Phase 2 clinical trials, there is a pressing need to identify selective Hsp90 inhibitors that are more soluble than 17-AAG [31].
The latter observations and other clinical studies suggest that a combination of IL-4 with IL-2 may be more effective in Phase II clinical trials [32].
Based on these findings, radiation in combination with intratumoral administration of a second generation Ad.EGR-TNF (TNFerade) has completed Phase I evaluation and has entered Phase II clinical trials [33].

Analytical, diagnostic and therapeutic context of Clinical Trials, Phase II

Using data obtained in 2 Phase II clinical trials of aprepitant in patients receiving chemotherapy based on the highly emetogenic chemotherapeutic agent cisplatin, we compared the time course of antiemetic effect of aprepitant, a 5-HT(3) antagonist, or a combination of both [34].
Thrombolysis In Myocardial Infarction flow grade (TFG), myocardial perfusion grade (MPG), and ST-segment resolution (STRes) were combined to formulate a new measure of successful reperfusion in 649 patients who received pharmacologic reperfusion therapy in 3 recent phase II clinical trials of ST-segment elevation myocardial infarction [35].
COX-2 inhibitors have been found to inhibit tumor growth in animal models and have demonstrated responses when combined with conventional therapy in phase II clinical trials [36].
The biochemical modulator 5-ethynyluracil may allow the oral administration of 5-FU; however, results of Phase II clinical trials are not yet available [37].
Adefovir dipivoxil, an orally bioavailable prodrug of adefovir is currently in phase III clinical trials for the treatment of HIV and phase II clinical trials for the treatment of HBV infections [38].

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