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PHASE-III TRIAL

A phase III trial of tirasemtiv as a potential treatment for amyotrophic lateral sclerosis

A phase III trial of tirasemtiv as a potential treatment for amyotrophic lateral sclerosis

... the phase III trial of dexpramipexole was ...the phase II trial of ...the phase 2 study (BENEFIT ALS), SVC was the measure that seemed to show the largest signal among all out- ...

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The Case for a Phase III Trial of Cerebral Intraarterial Fibrinolysis

The Case for a Phase III Trial of Cerebral Intraarterial Fibrinolysis

... Among a number of issues raised in their paper about the efficacy of directed intraarterial delivery of a fibrinolytic agent, several demand closer scrutiny: a Does cerebral arterial rec[r] ...

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Cerebral intraarterial fibrinolysis at the crossroads: is a phase III trial advisable at this time?

Cerebral intraarterial fibrinolysis at the crossroads: is a phase III trial advisable at this time?

... This compares with: i a rate of 17% 95% confidence interval, 2% to 48%, at 60 minutes, in the placebo group of a small randomized controlled trial of intravenous cerebral fibrinolysis 21[r] ...

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Review Article Efficacy and safety of nanoparticle albumin-bound paclitaxel for treating metastatic breast cancer: a meta-analysis

Review Article Efficacy and safety of nanoparticle albumin-bound paclitaxel for treating metastatic breast cancer: a meta-analysis

... randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevaci- zumab (B) as first-line therapy for ...

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Evaluating the Safety and Efficacy of Nivolumab in Patients with Advanced Hepatocellular Carcinoma: Evidence to Date

<p>Evaluating the Safety and Efficacy of Nivolumab in Patients with Advanced Hepatocellular Carcinoma: Evidence to Date</p>

... (SHARP trial), 8 there was a sad saga of almost a decade where no systemic therapeutic agent showed over- all survival bene fi ...a Phase III ...recent Phase I/II clinical trials involving ...

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A new trial design to accelerate tuberculosis drug development : the Phase IIC Selection Trial with Extended Post treatment follow up (STEP)

A new trial design to accelerate tuberculosis drug development : the Phase IIC Selection Trial with Extended Post treatment follow up (STEP)

... to phase III trials ...REMoxTB phase III trial [1], but these benefits did not translate into activity sufficient to cure patients in just 4 ...in phase II trials ...

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... a phase III trial (ARTIST trial) showed that postoperative chemoradiation with capecitabine and cisplatin did not significantly reduce recurrence after D2 lymph node dissection in patients ...

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Changing paradigms in management of metastatic Castration Resistant Prostate Cancer (mCRPC)

Changing paradigms in management of metastatic Castration Resistant Prostate Cancer (mCRPC)

... controlled phase III trial of 1195 patients (COU-AA-301) [33] comparing Abiraterone- prednisone ...this trial had received one prior chemotherapy regimen, and 30% had been treated with two ...

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Sorafenib in advanced hepatocellular carcinoma: current status and future perspectives

Sorafenib in advanced hepatocellular carcinoma: current status and future perspectives

... published Phase III trial, conducted in Japan and Korea, randomized 458 intermediate-stage HCC patients exhibiting $25% tumor necrosis or shrinkage after one or two sessions of TACE into the ...

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Profile of ramucirumab in the treatment of metastatic non-small-cell lung cancer

Profile of ramucirumab in the treatment of metastatic non-small-cell lung cancer

... one Phase II trial, single-nucleotide polymorphism rs2981582 on the FGFR-2 gene was statisti- cally significantly associated with improvements in OS, PFS, and best overall response ...the Phase ...

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Dalfampridine sustained-release for symptomatic improvement of walking speed in patients with multiple sclerosis

Dalfampridine sustained-release for symptomatic improvement of walking speed in patients with multiple sclerosis

... this Phase III trial was con- sistent with the results of the Phase II study showing good tolerability and an acceptable safety ...the Phase II trial, and included dizziness, ...

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Triple-negative breast cancer: treatment challenges and solutions

Triple-negative breast cancer: treatment challenges and solutions

... rates of pCR with carboplatin, but toxicities were also more frequent and more significant if carboplatin was added. More dose reductions and early study discontinuations occurred due to these toxicities. The incidence ...

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Decision theoretic designs for a series of trials with correlated treatment effects using the Sarmanov multivariate beta binomial distribution

Decision theoretic designs for a series of trials with correlated treatment effects using the Sarmanov multivariate beta binomial distribution

... in phase II clinical trials and where it may be infea- sible to try them concurrently because the intended population is ...of phase II trials. The program encompasses a series of sequential phase II ...

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Spotlight on crizotinib in the first-line treatment of ALK-positive advanced non-small-cell lung cancer: patients selection and perspectives

Spotlight on crizotinib in the first-line treatment of ALK-positive advanced non-small-cell lung cancer: patients selection and perspectives

... the Phase I clinical trial in 2011 in ALK-rearranged advanced NSCLC progressing after a first-line ...randomized Phase III trial PROFILE-1007 confirmed the efficacy of crizotinib in ...

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Mini-Review: Cabozantinib in the Treatment of Advanced Renal Cell Carcinoma and Hepatocellular Carcinoma

<p>Mini-Review: Cabozantinib in the Treatment of Advanced Renal Cell Carcinoma and Hepatocellular Carcinoma</p>

... (lead-in phase) and PFS (randomized ...lead-in phase, the ORR was only 5%, and there were no complete ...randomized phase, where patients were ran- domized to receive cabozantinib versus placebo ...

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Exploratory findings from a prematurely closed international, multicentre, academic trial: RAVELLO, a phase III study of regorafenib versus placebo as maintenance therapy after first-line treatment in RAS wild-type metastatic colorectal cancer

Exploratory findings from a prematurely closed international, multicentre, academic trial: RAVELLO, a phase III study of regorafenib versus placebo as maintenance therapy after first-line treatment in RAS wild-type metastatic colorectal cancer

... A 73-year-old Caucasian man, ECOG performance status 0, with no relevant comorbidities, was diagnosed in September 2014 with adenocarcinoma of the right colon and underwent right hemicolectomy, stage pT3 pN2 (7/18) cMx. ...

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B-cell-targeted therapies in systemic lupus erythematosus and ANCA-associated vasculitis: Current progress.

B-cell-targeted therapies in systemic lupus erythematosus and ANCA-associated vasculitis: Current progress.

... B cell depletion and inhibition can be achieved by targeting the CD22 molecule, another member of the BCR complex. CD22 inhibits BCR intracellular signalling. CD22 is a 140-kDa member of the sialo-glycoprotein expressed ...

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Chemovirotherapy: combining chemotherapeutic treatment with oncolytic virotherapy

Chemovirotherapy: combining chemotherapeutic treatment with oncolytic virotherapy

... planning phases (Tables 1–3). Some virotherapeutic agents used in these chemo viro therapeutic trials have therefore reached a more advanced stage, in both translational devel- opment and clinical testing, which can be ...

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Evaluating vandetanib in the treatment of medullary thyroid cancer: patient-reported outcomes

<p>Evaluating vandetanib in the treatment of medullary thyroid cancer: patient-reported outcomes</p>

... A recommended phase II dose (RP2D) for the combi- nation of vandetanib and bortezomib (for targeting RET in MTC) was performed. 99 Twenty-two patients with advanced MTC were enrolled and received escalating mg/m 2 ...

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