Clinical Trial Endpoints in Oncology
Clinical Trial Endpoints in Oncology
Clinical Trial Endpoints in Oncology
The primary endpoint for the approval of drugs in the oncology markets, which included colorectal, ovarian, head, neck and prostate cancer, was survival. The other endpoints in these markets were response rate (complete, partial, objective, overall response rate and so on). The major marketed drugs approved after 1990 in the colorectal cancer market were Camptosar (irinotecan), Xeloda (capecitabine), Avastin (Bevacizumab), Erbitux (cetuximab), Vectibix (panitumumab) and Eloxatin (oxaliplatin). The primary endpoint in all these drugs was survival, followed by median time to tumor progression, tumor response rate, progression-free survival, overall response rate and duration of response. In the prostate cancer market, the major marketed products were Taxotere (docetaxel), Casodex (Bicalutamide), Zoladex (Goserelin), Provenge (sipuleucel-T), Eligard (leuprolide acetate), Prostap (leuprolide acetate), Firmagon (degarelix), Vantas (Histrelin), Novantrone (Mitoxantrone hydrochloride), Trelstar (triptorelin). The primary and secondary endpoints in these included the median survival rate, prostate specific antigen (PSA) response, overall tumor response rate, disease-free survival, objective response, serum testosterone level and time to disease progression.
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The major marketed drugs after 1990 approved for head and neck cancer were Erbitux (cetuximab), Taxotere (docetaxel), Oncorine (H101, Modified Adenovirus) and Gendicine (Recombinant Human Ad-P53). The primary and secondary endpoints in these included median and overall survival rate, progression-free survival and complete response rate. Similarly, the major marketed drugs after 1990 approved for ovarian cancer were Altretamine (Hexalen), Gemcitabine (Gemzar), Hycamtin (Topotecan hydrochloride) and Yondelis (trabectedin). The primary and secondary endpoints of these drugs included overall and complete response rate, progression-free survival, time to response and overall survival.
GBI Research, the leading business intelligence provider, has released its latest research, "Clinical Trial Endpoints in Oncology Inclusion of Surrogate Endpoints and Shorter Endpoints will Ensure Faster Clinical Trials in Oncology". It provides in-depth analysis of the endpoints and application of endpoints in oncological clinical trials. The report analyzes the four major therapeutic area involved, which include colorectal cancer, prostate cancer, head and neck cancer and ovarian cancer. The report includes analysis of endpoints of major oncological market products and profiles. In addition to marketed products, the Phase III and Phase II clinical trials are also analyzed in terms of percentage cases. Analysis of terminated trials is also included in the report. Furthermore, the report provides competitive benchmarking for the leading companies and profiling of major companies in the oncology market.
It is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts.
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