Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT00802945
First received: December 4, 2008
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based treatment in the metastatic setting.

Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will be administered at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. Approximately 70 patients may be evaluated in this study with approximately 35 patients enrolled in each treatment arm.


Condition Intervention Phase
Tumor
Breast Cancer
Drug: NKTR-102
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 When Given on a Q14 Day or a Q21 Day Schedule in Patients With Metastatic or Locally Advanced Breast Cancer Whose Disease Has Failed Prior Taxane-Based Treatment

Resource links provided by NLM:


Further study details as provided by Nektar Therapeutics:

Primary Outcome Measures:
  • Objective Response Rate (ORR) as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: October 2008
Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NKTR-102 14 day
NKTR-102
Drug: NKTR-102
NKTR-102 given on a q14 day schedule
Experimental: NKTR-102 21 days
NKTR-102
Drug: NKTR-102
NKTR-102 given on a q21 day schedule

  Eligibility

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

Inclusion Criteria:

  1. Inoperable metastatic or locally advanced breast cancer
  2. No more than 2 prior chemotherapy regimens given in a metastatic or locally advanced setting and prior treatment in the metastatic setting must have included a taxane

Exclusion Criteria:

  1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1
  2. Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle or minor surgery within 2 weeks prior to Day 1 of Cycle 1
  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: NCT00802945

Locations
United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089-9177
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States, 92270
Stockton Hematology/Oncology
Stockton, California, United States, 95204
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
United States, Kentucky
Louisville Oncology Clinical Research Program
Louisville, Kentucky, United States, 40207
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, Rhode Island
Pharma Resource
East Providence, Rhode Island, United States, 02915
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Belgium
Institut Jules Bordet
Bruxelles, Belgium, 2-2-541-72-26
UZ Antwerpen
Edgem, Belgium, 2650
De Pintelaan 1885
Gent, Belgium, 9000
CHU de Liege
Liege, Belgium, 4000
GasthuisZusters Antwerpen
Wilrijk, Belgium, 2610
United Kingdom
Clatterbridge Centre for Oncology
Bebington, United Kingdom, CH63 3J7
Velindre Hospital
Cardiff, United Kingdom, CH14 2TL
Beatson Oncology Center
Glasgow, United Kingdom, G12 ONY
St James University Hospital
Leed, United Kingdom, LS97TF
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
Sponsors and Collaborators
Nektar Therapeutics
Investigators
Study Director: Ivan Gergel, MD Nektar Therapeutics
  More Information

No publications provided by Nektar Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT00802945     History of Changes
Other Study ID Numbers: 08-PIR-05
Study First Received: December 4, 2008
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014