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The Phase II study has a two-stage design and is evaluating two dose regimens of single-agent NKTR-102 in women with platinum-resistant ovarian cancer.
In mid-September 2009, Nektar announced that enrollment in the first stage of the study was complete and that multiple responses had been observed early in the first stage, which allowed the second stage of the study to be opened for both regimens ahead of schedule.
The study enrolled a total of 70 women whose tumors do not respond well to platinum-based chemotherapy, with 40 patients enrolled in the first stage and 30 patients enrolled in the second stage. The majority of the patients enrolled in the trial continue to receive treatment with NKTR-102.
In addition to the fully enrolled Phase II study currently underway in platinum-resistant ovarian cancer, NKTR-102 is also currently being tested in two separate Phase II clinical trials in patients with metastatic breast cancer and second-line colorectal cancer.
Lorianne Masuoka, chief medical officer of Nektar, said: "The majority of women in the NKTR-102 trial continue on therapy and we are looking forward to announcing preliminary response data from the study in the coming months. We are extremely excited about the potential of NKTR-102 to offer a valuable and promising new treatment option for women with platinum-resistant ovarian cancer."
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