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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Nektar Therapeutics
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT01457118
First received: October 19, 2011
Last updated: August 4, 2014
Last verified: August 2014

October 19, 2011
August 4, 2014
October 2011
February 2016   (final data collection date for primary outcome measure)
  • Safety [ Time Frame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up ] [ Designated as safety issue: Yes ]
    Incidence and duration of toxicities, with severity grading
  • Disease Progression [ Time Frame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up ] [ Designated as safety issue: No ]
    Disease progression and best response (per physician assessment)
Not Provided
Complete list of historical versions of study NCT01457118 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Solid Tumor
Drug: NKTR-102
A 90 minute IV infusion of 145 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle. Patients who previously received a dose of NKTR-102 < 145 mg/m2 will continue at the lower dose on this study.
Experimental: NKTR-102
Intervention: Drug: NKTR-102
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2018
February 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ivan Gergel, MD 415-482-5718 IGergel@nektar.com
Contact: Deirdre BeVard, BS 415-482-5694 DBeVard@nektar.com
United States,   Belgium
 
NCT01457118
11-PIR-09
No
Nektar Therapeutics
Nektar Therapeutics
Not Provided
Study Director: Ivan Gergel, MD Nektar Therapeutics
Nektar Therapeutics
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP