Track topics on Twitter Track topics that are important to you
The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.
Currently, there are no regulatory-approved or widely accepted treatment options for patients failing a standard pemetrexed-based chemotherapy regimen.
For this reason, the best supportive care (BSC) alone might be considered as a standard reference for a randomized phase III trial in this setting.
However, single-agent chemotherapeutic agents (such as doxorubicin,gemcitabine, or vinorelbine) with a well-documented safety profile and antitumor activity are also used in clinical practice.
Therefore, the best investigator's choice (BIC) between either best supportive care alone or combined with a few selected single-agent chemotherapy (including doxorubicin, gemcitabine, or vinorelbine) might be considered as an acceptable reference arm as well in this setting.
The current phase III study aims to show a superior efficacy in terms of overall survival duration of NGR-hTNF 0.8 µg/mq weekly plus BIC versus placebo plus BIC in advanced MPM patients progressing after a standard pemetrexed-based chemotherapy.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Malignant Pleural Mesothelioma
NGR-hTNF plus Best Investigator Choice (BIC), Placebo plus Best Investigator Choice (BIC)
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Published on BioPortfolio: 2014-08-27T03:14:46-0400
The main objective of the trial is to explore the safety and biological activity of NGR-hTNF. The safety will be established by clinical and laboratory assessment. The biological activity ...
The main objective of the trial is to document the safety and antivascular effect of escalating doses of NGR-hTNF, from 60 mcg/sqm to 325 mcg/sqm, in patients affected by advanced or metas...
The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic hepatocellular carcinoma patients treated with NGR-hTNF as single agent. ...
The main objective of the trial is to document the response rate in patients affected by metastatic ovarian cancer, treated with NGR-hTNF plus doxorubicin. Safety will be established by cl...
The main objective of the trial is to document the response rate in patients affected by metastatic soft tissue sarcomas, treated with NGR-hTNF plus doxorubicin. Safety will be established...
Intertemporal choices - decisions involving trade-offs of outcomes at different points in time - are often made under stress. Stress activates the hypothalamic-pituitary-adrenal (HPA) axis, resulting ...
The placebo effect is usually studied in clinical settings for decreasing negative symptoms such as pain, depression and anxiety. There is interest in exploring the placebo effect also outside the cli...
To compare symptom trajectories between placebo and active drug responders and to examine whether early placebo improvement would be associated with subsequent placebo response in the treatment of pat...
Although placebo analgesia is a well-recognized phenomenon with important clinical implications, the possibility that placebo effects occur during sleep has received little attention. This experimenta...
Laws requiring patients under managed care programs to receive services from the physician or other provider of their choice. Any willing provider laws take many different forms, but they typically prohibit managed-care organizations from having a closed panel of physicians, hospitals, or other providers.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
The Balanced Budget Act (BBA) of 1997 establishes a Medicare+Choice program under part C of Title XVIII, Section 4001, of the Social Security Act. Under this program, an eligible individual may elect to receive Medicare benefits through enrollment in a Medicare+Choice plan. Beneficiaries may choose to use private pay options, establish medical savings accounts, use managed care plans, or join provider-sponsored plans.
Expectation of real uncertainty on the part of the investigator regarding the comparative therapeutic merits of each arm in a trial.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...