Ixabepilone-associated peripheral neuropathy: data from across the phase II and III clinical trials

Deregulation of the PI3K-Akt-mTOR pathway plays a critical role in the development and progression of many cancers. In prostate cancer, evidence suggests that it is mainly driven by PTEN loss of function. For many years, the development of selective Akt inhibitors has been challenging. In recent phase II and III clinical trials, Ipatasertib and Capivasertib associated with androgen deprivation therapies showed promising outcomes in patients with metastatic castration-resistant prostate cancer and PTEN-loss. Ongoing trials are currently assessing several Akt inhibitors in prostate cancer with different combinations, at different stages of the disease.

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Antibiotics in Phase II and III Clinical Trials

Handbook of Experimental Pharmacology - Antibiotic Resistance ◽

10.1007/978-3-642-28951-4_11 ◽

2012 ◽

pp. 167-183 ◽

Cited By ~ 17

Author(s):

Anthony R. M. Coates ◽

Gerry Halls

Keyword(s):

Clinical Trials ◽

Phase Ii ◽

Phase Ii And Iii

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PrabotulinumtoxinA-xvfs for the Treatment of Moderate-to-Severe Glabellar Lines

Annals of Pharmacotherapy ◽

10.1177/1060028020943527 ◽

2020 ◽

pp. 106002802094352

Author(s):

Mary B. Gadarowski ◽

Rima I. Ghamrawi ◽

Sarah L. Taylor ◽

Steven R. Feldman

Keyword(s):

Clinical Trials ◽

Phase Ii ◽

Data Extraction ◽

Botulinum Toxin Type A ◽

Botulinum Toxin Type ◽

Phase Iii ◽

Phase Iii Clinical Trials ◽

Study Selection ◽

Pubmed Database ◽

Phase Ii And Iii

Objective: PrabotulinumtoxinA-xvfs (Jeuveau), a botulinum toxin type A, was approved by the Food and Drug Administration for the temporary improvement in the appearance of moderate-to-severe glabellar lines in February 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this novel, aesthetic-only drug. Data sources: A systematic literature review was performed using the terms “glabellar lines AND prabotulinumtoxinA” in the PubMed database. ClinicalTrials.gov was searched to identify nonpublished studies. Study Selection and Data Extraction: Articles written in English between November 2019 and June 2020 discussing phase II and phase III clinical trials were evaluated. Data Synthesis: By the primary efficacy end point on day 30, more patients achieved a greater than 2-point improvement on the Glabellar Line Scale (GLS) at maximum frown compared with baseline on day 0. The proportions of participants who responded to treatment with prabotulinumtoxinA were 67.5% and 70.4% versus 1.2% and 1.3% in placebo groups across 2 identical clinical trials ( P < 0.001). Patients receiving prabotulinumtoxinA experienced greater improvement in GLS at maximum frown on day 30 (87.2%) compared with onabotulinumtoxinA (82.8%) and placebo (4.2%; P < 0.001). PrabotulinumtoxinA was well tolerated across all studies. Relevance to Patient Care and Clinical Practice: This review provides a detailed analysis of the safety and efficacy of prabotulinumtoxinA-xvfs and includes special considerations to help guide patients and clinicians. Conclusion: PrabotulinumtoxinA is a safe and effective new addition to the repository of available treatments for the appearance of glabellar lines.

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Treating Psoriasis With Halobetasol Propionate and Tazarotene Combination: A Review of Phase II and III Clinical Trials

Annals of Pharmacotherapy ◽

10.1177/1060028020910439 ◽

2020 ◽

Vol 54 (9) ◽

pp. 872-878

Author(s):

Vignesh Ramachandran ◽

Brooke Bertus ◽

Arjun M. Bashyam ◽

Steven R. Feldman

Keyword(s):

Clinical Trials ◽

Phase Ii ◽

Plaque Psoriasis ◽

Patient Adherence ◽

Treatment Success ◽

Phase Iii ◽

Global Assessment Scale ◽

Once Daily ◽

Psoriasis Treatment ◽

Phase Ii And Iii

Objective: To review phase II and III clinical trial data to evaluate the efficacy and safety of the halobetasol propionate/tazarotene (HP/TAZ) combination lotion (Duobrii), a medication approved by the Food and Drug Administration in April 2019 for adults with plaque psoriasis. Data Sources: A systematic search (January 2005 to July 2019) of MEDLINE (PubMed) and EMBASE databases was performed using the terms halobetasol, tazarotene, halobetasol/tazarotene, Duobrii, and IDP-118. Study Selection and Data Extraction: Relevant English-language articles reporting on phase II and phase III clinical trials were included. Data from the individual trials were extracted independently and then cross-checked to ensure accuracy. Data Synthesis: HP/TAZ was safe and efficacious compared with HP alone, TAZ alone, or vehicle. More patients achieved treatment success, described as a ≥2-grade improvement on Investigator Global Assessment Scale, over 8 weeks of treatment and at the 4-week follow-up after treatment cessation. The most common adverse events were dermatitis, pain, and pruritus, which occurred more often in the TAZ groups compared with the HP/TAZ cohorts. Relevance to Patient Care and Clinical Practice: The once-daily HP/TAZ combination lotion simplifies psoriasis treatment and may facilitate adherence, which may improve psoriasis outcomes. Conclusions: HP/TAZ combination lotion is efficacious and safe for plaque psoriasis treatment, with more patients achieving end points and fewer side effects than in HP, TAZ, or vehicle-treated controls. Drug synergy may play a role. Importantly, patient adherence to a once-daily combinational therapy is likely to contribute to efficacy.

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Quetiapine: results of four phase II and III clinical trials

European Psychiatry ◽

10.1016/s0924-9338(98)82004-x ◽

1998 ◽

Vol 13 ◽

pp. 15s-21s

Author(s):

DJ King

Keyword(s):

Clinical Trials ◽

Phase Ii ◽

Phase Ii And Iii

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Evolution of statistical methodology and design of phase II/III clinical trials in non-small cell lung cancer (NSCLC)

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.7108 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 7108-7108 ◽

Cited By ~ 1

Author(s):

R. K. Bagai ◽

A. Dowlati

Keyword(s):

Clinical Trials ◽

Survival Time ◽

Phase Ii ◽

Response Rate ◽

Phase Iii ◽

Type I ◽

Phase Ii Trials ◽

Improvement In Survival ◽

Phase Ii And Iii ◽

Phase Iii Studies

7108 Background: A significant heterogeneity exists in the design and reporting of phase II and III therapeutic clinical trials in NSCLC. This has led to difficulty in interpretation of these trials leading to over- or underestimation of therapeutic efficacy. We set out to investigate the statistical methodology and design reporting of chemotherapeutic trials in NSCLC published in the Journal of Clinical Oncology (JCO) over 20 years. Methods: We identified all phase II and III NSCLC chemotherapy trials published in the JCO from January 1983 to August 2005. All manuscripts were reviewed to evaluate components of statistical design that were reported, including: sample size calculation, power, type I error, single or multiple drug trials, relative response sought in phase II trials and improvement in survival time or response rate sought in phase III trials. Results: One hundred forty eight trials were identified. 52% of studies were phase III and 48% were phase II. The majority (78%) were conducted in advanced stage NSCLC. Sample size calculations were reported for only 58% of phase III studies and 31% of phase II studies. Power was reported in 66% of phase III studies and 13% of phase II trials. Type I error was reported in 47% of phase III studies and 17% in phase II studies. 60% of phase III trials defined endpoints (percentage improvement in survival time, improvement in survival time in months or increase in response rate). 41% of phase II trails defined the target response rate, ranging from response rates of 15% to 70%. The frequency of adequate reporting of statistical design was shown to increase from 31% in 1990–1995 to 64% in 2000–2005 ( table ). Conclusions: Significant heterogeneity exists in trial design and reporting of phase II and III trials in NSCLC. This impacts the ability to adequately interpret these studies. More widespread application of statistical methods in planning and reporting of lung cancer clinical trials are necessary to increase reliability of data. [Table: see text] No significant financial relationships to disclose.

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Network Pharmacology-Based Approach to Investigate the Analgesic Efficacy and Molecular Targets of Xuangui Dropping Pill for Treating Primary Dysmenorrhea

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2017/7525179 ◽

2017 ◽

Vol 2017 ◽

pp. 1-12 ◽

Cited By ~ 11

Author(s):

Jihan Huang ◽

Lei Li ◽

Fan Cheung ◽

Ning Wang ◽

Yunfei Li ◽

...

Keyword(s):

Clinical Trials ◽

Phase Ii ◽

Molecular Targets ◽

Target Prediction ◽

Analgesic Efficacy ◽

Network Pharmacology ◽

Therapeutic Effects ◽

Primary Dysmenorrhea ◽

Active Compounds ◽

Phase Ii And Iii

This study aimed to evaluate the clinical analgesic efficacy and identify the molecular targets of XGDP for treating primary dysmenorrhea (PD) by a network pharmacology approach. Analysis of pain disappearance rate of XGDP in PD treatment was conducted based on data from phase II and III randomized, double-blind, double-simulation, and positive parallel controlled clinical trials. The bioactive compounds were obtained by the absorption, distribution, metabolism, and excretion processes with oral bioavailability (OB) and drug-likeness (DL) evaluation. Subsequently, target prediction, pathway identification, and network construction were employed to clarify the mechanisms of the analgesic effect of XGDP on PD. The pain disappearance rates in phase II and III clinical trials of XGDP in PD treatment were 62.5% and 55.8%, respectively, yielding a significant difference (P<0.05) when compared with the control group using Tongjingbao granules (TJBG). Among 331 compounds, 53 compounds in XGDP were identified as the active compounds related to PD through OB, DL, and target prediction. The active compounds and molecular targets of XGDP were identified, and our study showed that XGDP may exert its therapeutic effects on PD through the regulation of the targets related to anti-inflammation analgesia and central analgesia and relieving smooth muscle contraction.

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Novel drugs against tuberculosis: a clinician's perspective

European Respiratory Journal ◽

10.1183/09031936.00162314 ◽

2014 ◽

Vol 45 (4) ◽

pp. 1119-1131 ◽

Cited By ~ 39

Author(s):

Ioana Diana Olaru ◽

Florian von Groote-Bidlingmaier ◽

Jan Heyckendorf ◽

Wing Wai Yew ◽

Christoph Lange ◽

...

Keyword(s):

Clinical Trials ◽

Phase Ii ◽

Multidrug Resistant ◽

Drug Resistant ◽

Drug Resistant Tuberculosis ◽

Resistant Tuberculosis ◽

Phase Ii Clinical Trials ◽

Multidrug Resistant Tuberculosis ◽

Novel Drugs ◽

Phase Ii And Iii

The United Nations Millennium Development Goal of reversing the global spread of tuberculosis by 2015 has been offset by the rampant re-emergence of drug-resistant tuberculosis, in particular fluoroquinolone-resistant multidrug-resistant and extensively drug-resistant tuberculosis. After decades of quiescence in the development of antituberculosis medications, bedaquiline and delamanid have been conditionally approved for the treatment of drug-resistant tuberculosis, while several other novel compounds (AZD5847, PA-824, SQ109 and sutezolid) have been evaluated in phase II clinical trials. Before novel drugs can find their place in the battle against drug-resistant tuberculosis, linezolid has been compassionately used with success in the treatment of fluoroquinolone-resistant multidrug-resistant tuberculosis. This review largely discusses six novel drugs that have been evaluated in phase II and III clinical trials, with focus on the clinical evidence for efficacy and safety, potential drug interactions, and prospect for using multiple novel drugs in new regimens.

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