An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies
Description
Brief Summary
The study objective of this open label, multicenter study is to provide access to NKTR-102
treatment to subjects previously enrolled in a NKTR-102 study who are without signs of
disease progression since receiving NKTR-102.
In addition the study will evaluate the safety of continued exposure to NKTR-102, observe
disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy
of NKTR-102 in subjects with advanced or metastatic solid tumors.
Phase
Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.Inclusion and Exclusion Criteria
- Received prior treatment with NKTR-102
- Free of disease progression since receiving NKTR-102
- Adequate bone marrow and organ function
- Treatment with NKTR-102 in the extension study to begin within 8 weeks after receipt of their of last dose of NKTR-102
- Agree to use adequate contraception
- Treatment with other anti-cancer therapy between the last dose of NKTR-102 in the prior study and before first dose of NKTR-102 in the extension study
- A toxicity that requires a 3rd dose reduction after taking NKTR-102 or are scheduled to receive a dose < 70 mg/m2 upon entry into this study
- Pregnancy or lactation
Sites
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California
- USC Norris Comprehensive Cancer Center, Los Angeles, California, 90033
- UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, 94143
-
Minnesota
- University of Minnesota, Minneapolis, Minnesota, 55455
- Mayo Clinic, Rochester, Minnesota, 55905
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