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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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.

Official Title

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

Keywords

Malignant Solid Tumor Open Label multicenter extension study advanced solid tumors

Eligibility

For people ages 18 years and up

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

Locations

  • USC Norris Comprehensive Cancer Center accepting new patients
    Los Angeles, California, 90033, USA
  • Innovative Clinical Research Institute in progress, not accepting new patients
    Whittier, California, 90603, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Nektar Therapeutics
ID
NCT01457118
Phase
Phase 2
Lead Scientist
Pamela Munster
Study Type
Interventional
Last Updated
December 2016
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