An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies
Subjects must fulfill Inclusion Criteria to be eligible for study entry:
1. Previous treatment with NKTR-102 with demonstrated clinical benefit
2. ECOG performance score of 0 or 1
3. Adequate bone marrow and organ function at screening
4. Receive the first dose of NKTR-102 int he extension study within 12 weeks of
receiving their last dose of the NKTR-102 in the original protocol
Subjects meeting any of the Exclusion Criteria are ineligible for enrollment:
1. Received intervening anti-cancer therapy between last dose int he original protocol
and administration of the first dose in the extension study
2. Had major surgery within 4 weeks prior to Day 1 of Cycle 1 or minor surgery within 2
weeks prior to Day 1 Cycle 1.
3. Received cytochrome P450 #4A(CYP3A4)inducers or inhibitors
4. Receiving anti-cancer biologic agents with 28 days of Day 1 Cycle 1
5. Have unresolved or irreversible NKTR-102 related ongoing AE occurring during the
6. Have diarrhea.