An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies

Status:	Completed
Conditions:	Breast Cancer, Colorectal Cancer, Ovarian Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	5/3/2018
Start Date:	October 2011
End Date:	November 2017

An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies

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.

Inclusion:

1. Received prior treatment with NKTR-102

2. Free of disease progression since receiving NKTR-102

3. Adequate bone marrow and organ function

4. Treatment with NKTR-102 in the extension study to begin within 8 weeks after receipt
of their of last dose of NKTR-102

5. Agree to use adequate contraception

Exclusion:

1. 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

2. 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

3. Pregnancy or lactation

We found this trial at

sites

Univ of Minnesota

Minneapolis, Minnesota 55455

(612) 625-5000