Phase II Clinical Trials
The number of participants in the Phase II clinical trials for Mesothelioma is far more than that in the Phase I trials and the number is usually 100 or a little less. The Phase II trials are carried out to measure the effectiveness of a drug while still focusing on the safety factors. There is no effective treatment till date on some cancers. These cancers are the focal point of study for the Phase II trials.
Same dosage of investigational drug is given to all the participants. Assessment is carried out on the effectiveness of the drug and additional notes are taken down on safety. If a drug appears to be beneficial then it is subjected to further tests before its use on a wide scale. The long term benefits of a drug can only be felt if trials are organized for a longer period. But the Phase II trials are not compared with the present standard of therapy and thereby the long term impact of the drug is not ascertained. In this case, the Phase III trials are more fruitful.
In some Phase II trials, the same drug under investigation is given to different groups of patients under different schedules. The patients are allocated to two groups- investigational, the control groups in a random manner, and it is even beyond the capacities of a doctor to allocate a particular patient in a particular group. After the closure of the trial, the most promising course of therapy is approved for the Phase III trials.
The current standard treatment of Mesothelioma consisting of Alimta/cisplatin has not proved to be effective enough for the Mesothelioma patients participating in the Phase II trials. The eligibility criteria for this phase include adequate organ function with a minimum life expectancy of three months. The participants must have experienced a limited therapy prior to this trial. Every drug has a separate eligibility criteria and a medical professional can provide guidance in this regard.