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Some Phase II trials are designed as case series, demonstrating a drug's safety and activity in a selected group of participants. Other Phase II trials are designed as randomized controlled trials, where some patients receive the drug/device and others receive placebo/standard treatment. Randomized Phase II trials have far fewer patients than ...
[9] [10] [8] The Phase II portion of the trial sought to compare the efficacy of Abituzumab, cetuximab, and irinotecan compared to cetuximab and irinotecan in patients with KRAS (exon 2) wild-type metastatic colorectal cancer. Patients included in the study failed treatment with oxaliplatin, and initial safety studies included comparing ...
A phase 1 clinical trial in 2004 demonstrated the safety and tolerability of mapatumumab in cancer patients with advanced solid tumors or non-Hodgkin’s lymphoma, and supported further evaluation in phase 2 clinical trials, both as a single agent and in combination with chemotherapy. [4]
I-SPY 2 is an adaptive clinical trial of multiple Phase 2 treatment regimens combined with standard chemotherapy. I-SPY 2 linked 19 academic cancer centers, two community centers, the FDA, the NCI, pharmaceutical and biotech companies, patient advocates and philanthropic partners.
The Clinical Center provides an environment for both patient care and conducting clinical trials, most of which are in Phase I or Phase II. [1] In 2014, of the 773 active clinical trials protocols, 23% were Phase I trials (261 protocols), 60% were Phase II trials (462 protocols), 5% were Phase III (39 protocols) and 3% were Phase IV (11 ...
This clinical trial was the only trial not sponsored by Morphotek or Eisai but by the National Cancer Institute (NCI). [11] However, Morphotek had just completed a similar Phase I trial just prior in March 2013. The results of this study have not been posted. [12] Two of the Phase II trials are complete.
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