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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01457118
Recruitment Status : Active, not recruiting
First Posted : October 21, 2011
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Malignant Solid Tumor Drug: NKTR-102 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies
Actual Study Start Date : October 2011
Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Safety [ Time Frame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up ]
    Incidence and duration of toxicities, with severity grading

  2. Disease Progression [ Time Frame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up ]
    Disease progression and best response (per physician assessment)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457118


Locations
United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
Innovative Clinical Research Institute
Whittier, California, United States, 90603
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Ohio
University Hospital of Cleveland, Case Medical Center, Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Belgium
Institut Jules Bordet
Bruxelles, Belgium
CHU de Liege
Liege, Belgium, 4000
Sponsors and Collaborators
Nektar Therapeutics
Investigators
Study Director: Ivan Gergel, MD Nektar Therapeutics
More Information

Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT01457118     History of Changes
Other Study ID Numbers: 11-PIR-09
First Posted: October 21, 2011    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

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