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

Expanded access is currently available for this treatment.
Verified April 2013 by Nektar Therapeutics
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT01457118
First received: October 19, 2011
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

The study objective of this open label, multicenter study is to provide access to NKTR-102 treatment to subjects previously enrolled in NKTR-102 studies and to evaluate the safety of long-term exposure to NKTR-102.

In additional the study will track disease progression and survival status in subjects who have ongoing clinical benefit from continued treatment with NKTR-102.


Condition Intervention
Malignant Solid Tumour
Breast Cancer
Ovarian Cancer
Colorectal Cancer
 Drug: NKTR-102

Study Type: Expanded Access     What is Expanded Access?
Official Title: An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nektar Therapeutics:

Study Start Date: October 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: NKTR-102
    Dose will carry forward from original NKTR-102, IV administration of NKTR-102 will occur on Day 1 of each cycle. Cycle length will be determined by schedule used in original NKTR-102 study.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion:

Subjects must fulfill Inclusion Criteria to be eligible for study entry:

  1. Previous treatment with NKTR-102 with demonstrated clinical benefit
  2. ECOG performance score of 0 or 1
  3. Adequate bone marrow and organ function at screening
  4. Receive the first dose of NKTR-102 int he extension study within 12 weeks of receiving their last dose of the NKTR-102 in the original protocol

Exclusion:

Subjects meeting any of the Exclusion Criteria are ineligible for enrollment:

  1. Received intervening anti-cancer therapy between last dose int he original protocol and administration of the first dose in the extension study
  2. Had major surgery within 4 weeks prior to Day 1 of Cycle 1 or minor surgery within 2 weeks prior to Day 1 Cycle 1.
  3. Received cytochrome P450 #4A(CYP3A4)inducers or inhibitors
  4. Receiving anti-cancer biologic agents with 28 days of Day 1 Cycle 1
  5. Have unresolved or irreversible NKTR-102 related ongoing AE occurring during the original protocol
  6. Have diarrhea.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457118

Contacts
Contact: Robert Medve, MD 415-482-5300 RMedve@nektar.com
Contact: Charleen Jue, BS 415-482-5300 cjue@nektar.com

Locations
United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Principal Investigator: Agustin A. Garcia, MD            
Belgium
Institut Jules Bordet
Bruxelles, Belgium, 2-2-541-72-26
Contact: Muriel Dulere     32-2-541-72-26        
Principal Investigator: Ahmad Awada, MD            
CHU de Liege
Liege, Belgium, 4000
Contact: Mathieu Leroy     32-4366.71.11 ext 105        
Principal Investigator: Guy Jerusalem, MD            
Sponsors and Collaborators
Nektar Therapeutics
Investigators
Study Director: Robert Medve, 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: April 30, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Ovarian Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 19, 2013