Celgene Corp. (CELG) said its unit Celgene International Sàrl announced results of its phase III, randomized, international study (CA033) of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in chemotherapy-naïve patients with metastatic melanoma.
The CA033 study is a Celgene-sponsored, open-label, controlled, randomized study comparing ABRAXANE to standard chemotherapy, DTIC, in patients with metastatic melanoma.
In the study, the primary endpoint was met with patients receiving ABRAXANE demonstrating a statistically significant improvement in progression-free survival compared to patients receiving dacarbazine, or DTIC, chemotherapy. Secondary endpoints included overall survival, overall response rate and disease control, safety and tolerability.
Celgene noted that the safety profile of ABRAXANE observed in the CA033 study is consistent with other ABRAXANE pivotal clinical trials.
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