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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
  Purpose

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.


Condition Intervention Phase
Malignant Solid Tumor
Drug: NKTR-102
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies

Resource links provided by NLM:


Further study details as provided by Nektar Therapeutics:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 150
Study Start Date: October 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NKTR-102 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457118

Contacts
Contact: Ivan Gergel, MD 415-482-5718 IGergel@nektar.com
Contact: Deirdre BeVard, BS 415-482-5694 DBeVard@nektar.com

Locations
United States, California
USC Norris Comprehensive Cancer Center Active, not recruiting
Los Angeles, California, United States, 90033
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94143
Contact: Paula Fiermonte    415-885-7605    fiermontep@cc.ucsf.edu   
Principal Investigator: Pamela Munster, MD         
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Carrie McCann    612-626-2569    mcca0313@umn.edu   
Principal Investigator: Edward Greeno, MD         
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Mayo Clinic Recruiting, Clinical Trials Office    507-538-7623      
Principal Investigator: Paul Haluska, MD         
United States, Ohio
University Hospital of Cleveland, Case Medical Center, Seidman Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Smitha Krishnamurthi, MD    216-844-5467    smitha.krishnmurthi@uhhospitals.org   
Principal Investigator: Smitha Krishnamurthi, MD         
Belgium
Institut Jules Bordet Active, not recruiting
Bruxelles, Belgium
CHU de Liege Active, not recruiting
Liege, Belgium, 4000
Sponsors and Collaborators
Nektar Therapeutics
Investigators
Study Director: Ivan Gergel, MD Nektar Therapeutics
  More Information

No publications provided

Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT01457118     History of Changes
Other Study ID Numbers: 11-PIR-09
Study First Received: October 19, 2011
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Keywords provided by Nektar Therapeutics:
Open Label multicenter extension study advanced solid tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 23, 2014