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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

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

  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco, California, 94143, United States
  • USC Norris Comprehensive Cancer Center
    Los Angeles, California, 90033, United States
  • Innovative Clinical Research Institute
    Whittier, California, 90603, United States

Details

Status
in progress, not 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
October 5, 2017