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

This study is currently recruiting participants.

Verified by Nektar Therapeutics, February 2009

First Received: December 4, 2008 Last Updated: February 20, 2009 History of Changes

Sponsored by:	Nektar Therapeutics
Information provided by:	Nektar Therapeutics
ClinicalTrials.gov Identifier:	NCT00802945

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 170 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 II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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

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 ]

Estimated Enrollment:	70
Study Start Date:	October 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental NKTR-102	Drug: NKTR-102 NKTR-102 given on a q14 day schedule
2: Experimental 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:

Inoperable metastatic or locally advanced breast cancer
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:

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802945

Locations

United States, Illinois
Southern Illinois Hematology/Oncology	Recruiting
Centralia, Illinois, United States, 62801
Contact: Lynn Ann Waggoner-Pigg, RN, MSN 618-533-5000
Principal Investigator: James Hays, MD
United States, Kentucky
Louisville Oncology Clinical Research Program	Recruiting
Louisville, Kentucky, United States, 40207
Contact: Julie Brown 502-629-2500
Principal Investigator: John T Hamm, MD

Sponsors and Collaborators

Nektar Therapeutics

Investigators

Study Director:

Lorianne Masuoka, MD

Nektar Therapeutics

More Information

No publications provided

Responsible Party:	Nektar Therapeutics ( Lorianne Masuoka, MD, Vice President, Clinical Development )
Study ID Numbers:	08-PIR-05
Study First Received:	December 4, 2008
Last Updated:	February 20, 2009
ClinicalTrials.gov Identifier:	NCT00802945 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Taxane
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009