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Phase II clinical programs historically have experienced the lowest success rate of the four development phases. In 2010, the percentage of Phase II trials that proceeded to Phase III was 18%, [16] and only 31% of developmental candidates advanced from Phase II to Phase III in a study of trials over 2006–2015. [17]
Clinical trials evaluated rebimastat's efficacy and safety in various cancers, including prostate cancer, HIV-related Kaposi's sarcoma, non-small cell lung cancer (NSCLC), and breast cancer. These included multiple phase II trials and at least one phase III trial. [3] [4] [6]
It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors. In the completed Phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses with two complete and six partial responses.
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.
As of January 2017, there are 6 phase II clinical trials in progress: Second-line therapy for patients with glioblastoma [1] Treatment of HIV-positive patients with Kaposi's sarcoma [2] Combination therapy of ifosfamide and aldoxorubicin for treatment of metastatic or locally advanced sarcoma [3]
Phase II-a is specifically designed to assess dosing requirements (how much drug should be given), [13] [45] while a Phase II-b trial is designed to determine efficacy (100–300 people), [1] assessing how well the drug works at the prescribed dose(s) to establish a therapeutic dose range and monitor for possible side effects. [45] Phase III
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