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PubMed Journals Articles About "Starts Phase Trial TTP399" RSS

13:35 EST 16th December 2018 | BioPortfolio

Starts Phase Trial TTP399 PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Starts Phase Trial TTP399 articles that have been published worldwide.

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Showing "starts Phase trial TTP399" PubMed Articles 1–25 of 10,000+

A Hybrid Phase I-II/III Clinical Trial Design Allowing Dose Re-Optimization in Phase III.

Conventionally, evaluation of a new drug, A, is done in three phases. Phase I is based on toxicity to determine a \maximum tolerable dose" (MTD) of A, phase II is conducted to decide whether A at the MTD is promising in terms of response probability, and if so a large randomized phase III trial is conducted to compare A to a control treatment, C; usually based on survival time or progression free survival time. It is widely recognized that this paradigm has many flaws. A recent approach combines the first t...


Effect of Anlotinib as a Third-Line or Further Treatment on Overall Survival of Patients With Advanced Non-Small Cell Lung Cancer: The ALTER 0303 Phase 3 Randomized Clinical Trial.

Anlotinib is a novel multitarget tyrosine kinase inhibitor for tumor angiogenesis and proliferative signaling. A phase 2 trial showed anlotinib to improve progression-free survival with a potential benefit of overall survival, leading to the phase 3 trial to confirm the drug's efficacy in advanced non-small cell lung cancer (NSCLC).

Quantitative decision-making in randomized Phase II studies with a time-to-event endpoint.

One of the most critical decision points in clinical development is Go/No-Go decision-making after a proof-of-concept study. Traditional decision-making relies on a formal hypothesis testing with control of type I and type II error rates, which is limited by assessing the strength of efficacy evidence in a small isolated trial. In this article, we propose a quantitative Bayesian/frequentist decision framework for Go/No-Go criteria and sample size evaluation in Phase II randomized studies with a time-to-even...


The HEURECA Method: Tracking Multiple Phase Coupling Dynamics on a Single Trial Basis.

Although acquisition techniques have improved tremendously, the neuroscientific understanding of complex cognitive phenomena is still incomplete. One of the reasons for this shortcoming may be the lack of sophisticated signal processing methods. Complex cognitive phenomena usually involve various mental subprocesses whose temporal occurrence varies from trial to trial. Mostly, these mental subprocesses require large-scale integration processes between multiple brain areas that are most likely mediated by co...

A Bayesian design for phase I cancer therapeutic vaccine trials.

Phase I clinical trials are the first step in drug development to test a new drug or drug combination on humans. Typical designs of Phase I trials use toxicity as the primary endpoint and aim to find the maximum tolerable dosage. However, these designs are poorly applicable for the development of cancer therapeutic vaccines because the expected safety concerns for these vaccines are not as much as cytotoxic agents. The primary objectives of a cancer therapeutic vaccine phase I trial thus often include deter...

A randomised phase II trial of capecitabine plus cisplatin versus S-1 plus cisplatin as a first-line treatment for advanced gastric cancer: Capecitabine plus cisplatin ascertainment versus S-1 plus cisplatin randomised PII trial (XParTS II).

Capecitabine plus cisplatin (XP) is a standard global regimen, while S-1 plus cisplatin (SP) is a Japanese standard for first-line treatment of advanced gastric cancer (AGC). We conducted a phase II trial comparing XP with SP for patients with AGC to confirm whether these regimens can be used as controls in a phase III study and to explore whether histological subtypes favour XP or SP.

Circulating biomarkers from the phase I trial of sirolimus and autophagy inhibition for patients with lymphangioleiomyomatosis (SAIL).

We have previously conducted the Sirolimus and Autophagy Inhibition in LAM (SAIL) trial, a phase I dose escalation study of the combination of sirolimus and hydroxychloroquine in patients with lymphangioeliomyomatosis (LAM). The goal of the present study was to analyze sera from the SAIL trial to identify novel biomarkers that could shed light into disease pathogenesis and response to therapy.

Healthy volunteers' perceptions of risk in US Phase I clinical trials: A mixed-methods study.

There is limited research on healthy volunteers' perceptions of the risks of Phase I clinical trials. In order to contribute empirically to long-standing ethical concerns about healthy volunteers' involvement in drug development, it is crucial to assess how these participants understand trial risks. The objectives of this study were to investigate (1) participants' views of the overall risks of Phase I trials, (2) their views of the risk of personally being harmed in a trial, and (3) how risk perceptions va...

Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial.

This phase III, double-blind, randomised, placebo-controlled trial (and extension phase) was designed to assess the efficacy and safety of velmanase alfa (VA) in alpha-mannosidosis (AM) patients.

Choroideremia Gene Therapy Phase 2 Clinical Trial: 24-Month Results.

To report the final results of a phase 2 high-dose gene therapy clinical trial in choroideremia.

Dose escalation in extracranial stereotactic ablative radiotherapy (DESTROY-1): a multi-arm phase I trial.

A multi arm phase I clinical trial was performed to define the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) delivered by non-coplanar conformal beams or Volumetric Modulated Arc Therapy technique in 7 predefined clinical settings.

Phase I/II Trial of Chemotherapy with Docetaxel, Cisplatin, and S-1 for Unresectable Advanced Squamous Cell Carcinoma of the Esophagus.

Our previous trial with a docetaxel, cisplatin, and 5-fluorouracil (DCF) regimen showed high response rates in metastatic squamous cell carcinoma of the esophagus (SCCE). The observed increased toxicity of the DCF regimen, however, was clinically harmful. S-1, an oral anticancer drug, has been approved as a combination therapy for SCCE, and alternate-day regimen with S-1 has shown lower levels of toxicity. This prospective single-center phase I/II trial examines the efficacy and toxicity of a combination of...

Moderate hypofractionation in intermediate and high risk, localized prostate cancer: Health-related quality of life from the randomized, phase 3 HYPRO trial.

The phase 3 HYPRO trial compared hypofractionated radiotherapy with conventionally fractionated radiotherapy in patients with localized prostate cancer. Similar 5-year relapse-free survival rates were achieved, whereas non-inferiority of hypofractionation was not confirmed for genitourinary and gastrointestinal toxicity. Here, we present the secondary trial endpoint on patient-reported quality of life.

Sensorimotor Oscillatory Phase-Power Interaction Gates Resting Human Corticospinal Output.

Oscillatory activity within sensorimotor networks is characterized by time-varying changes in phase and power. The influence of interactions between sensorimotor oscillatory phase and power on human motor function, like corticospinal output, is unknown. We addressed this gap in knowledge by delivering transcranial magnetic stimulation (TMS) to the human motor cortex during electroencephalography recordings in 20 healthy participants. Motor evoked potentials, a measure of corticospinal excitability, were cat...

Adsorption of molecular oxygen on the Ag(111) surface: A combined temperature-programmed desorption and scanning tunneling microscopy study.

The adsorption of O on Ag(111) between 300 and 500 K has been studied with temperature-programmed desorption (TPD) and scanning tunneling microscopy (STM). At the first stage of adsorption, the disordered local oxide phase (commonly looking in STM as an array of black spots) is formed on the surface irrespective of the substrate temperature. The maximum concentration of black spots was found to be ≈0.11 ML, which corresponds to an oxygen coverage of ≈0.66 ML. Taking into account that the nucleation of t...

Oral dydrogesterone for luteal phase support in fresh in vitro fertilization cycles: a new standard?

Oral dydrogesterone has been used for luteal phase support on an empirical basis since the early days of in vitro fertilization (IVF) treatment. Systematic comparisons of oral dydrogesterone with vaginal progesterone, so far considered to be the standard of care, started to appear in the middle 2000s. Recently, a large, randomized, double-blind, double-dummy phase III trial on the use of daily 30 mg oral dydrogesterone versus daily 600 mg micronized vaginal progesterone for LPS in IVF was published. This...

A Phase I Trial of Surgical Resection and Intraoperative Hyperthermic Cisplatin and Gemcitabine for Pleural Mesothelioma.

The primary objective of this single-institution Phase I clinical trial was to establish the maximum tolerated dose (MTD) of gemcitabine added to cisplatin delivered as heated intraoperative chemotherapy (HIOC) following resection of malignant pleural mesothelioma (MPM).

Low-Level Laser Treatment Is Ineffective for Capsular Contracture: Results of the LaTCon Randomized Controlled Trial.

Breast reconstruction with implants can be complicated by symptomatic capsular contracture, especially after radiotherapy. A phase I, nonrandomized clinical trial demonstrated improvement in capsular contracture and avoidance of revision surgery with low-level laser therapy. This phase II, double-blind, randomized controlled trial assessed the efficacy of low-level laser for treating capsular contracture in women with breast reconstruction following mastectomy for breast cancer.

Impact of age on the efficacy of oxaliplatin in the preoperative chemoradiotherapy and adjuvant chemotherapy of rectal cancer: A post hoc analysis of the CAO/ARO/AIO-04 phase 3 trial.

The German rectal cancer trial CAO/ARO/AIO-04 has shown a significant benefit in 3-year disease-free survival (DFS) of adding oxaliplatin to a standard preoperative 5-fluorouracil-based chemoradiotherapy (CRT) and adjuvant chemotherapy in patients with locally advanced rectal cancer. The use of oxaliplatin as adjuvant treatment in elderly patients with colon cancer is controversial . We therefore investigated the impact of age on clinical outcome in the CAO/ARO/AIO-04 phase 3 trial.

A phase I clinical trial of ruxolitinib in combination with nilotinib in chronic myeloid leukemia patients with molecular evidence of disease.

Preclinical evidence indicates that the bone marrow microenvironment provides a protective niche for leukemic stem cells, allowing them to evade the effects of BCR-ABL tyrosine kinase inhibitors (TKIs), but that targeting of the JAK-STAT pathway with the JAK2 inhibitor ruxolitinib increases TKI-induced apoptosis. A phase I clinical trial (NCT01702064) investigated the tolerability and safety of treating chronic-phase chronic myeloid leukemia patients with ruxolitinib in combination with the BCR-ABL TKI nilo...

Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial.

 Polyethylene glycol (PEG) bowel preparations are widely used for precolonoscopy bowel cleansing. This phase 3 trial assessed the efficacy, safety, and tolerability of the novel 1 L PEG-based NER1006 vs. sodium picosulfate plus magnesium citrate (SP + MC) in day-before dosing.

Epacadostat Plus Pembrolizumab in Patients With Advanced Solid Tumors: Phase I Results From a Multicenter, Open-Label Phase I/II Trial (ECHO-202/KEYNOTE-037).

Tumors may evade immunosurveillance through upregulation of the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme. Epacadostat is a potent and highly selective IDO1 enzyme inhibitor. The open-label phase I/II ECHO-202/KEYNOTE-037 trial evaluated epacadostat plus pembrolizumab, a programmed death protein 1 inhibitor, in patients with advanced solid tumors. Phase I results on maximum tolerated dose, safety, tolerability, preliminary antitumor activity, and pharmacokinetics are reported.

Short Course High-dose Liposomal Amphotericin B for HIV-associated Cryptococcal Meningitis: A phase-II Randomized Controlled Trial.

Cryptococcal meningitis (CM) causes 10-20% of HIV-related deaths in Africa. We performed a phase-II non-inferiority trial examining the Early Fungicidal Activity (EFA) of three short-course, high-dose liposomal amphotericin B (L-AmB) regimens for CM in Tanzania and Botswana.

Evaluation of factors contributing to the response to fosaprepitant in a heterogeneous, moderately emetogenic chemotherapy population: an exploratory analysis of a randomized phase III trial.

Fosaprepitant improved prevention of chemotherapy-induced nausea and vomiting (CINV) in a randomized, double-blind phase III trial (PN031). This post hoc analysis explored factors that may have influenced response.

Shortening intradermal rabies post-exposure prophylaxis regimens to 1 week: Results from a phase III clinical trial in children, adolescents and adults.

This phase III clinical trial compared the immunogenicity and safety of a purified chick-embryo cell rabies vaccine (PCECV) administered according to a shortened post-exposure prophylaxis (PEP) 4-site/1-week intradermal regimen, compared with the currently recommended 2-site/Thai Red Cross (TRC).


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