Clinical trial NCT00802945: Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tumor
Breast Cancer
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 2 years.
Secondary outcomes:
measure: Kaplan Meier Estimate of Progression-Free Survival (PFS)
timeFrame: Up to 2 years.
measure: Kaplan Meier Estimate of Overall Survival (OS)
timeFrame: Up to 2 years.
measure: Kaplan Meier Estimate of 6-month Survival
timeFrame: From Cycle 1 Day 1 to the end of 6 months.
measure: Kaplan Meier Estimate of 1-year Survival
timeFrame: From Cycle 1 Day 1 to the end of 12 months.
measure: Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group
timeFrame: Up to 2 years.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group
state: California
city: Stockton
country: United States
facility: Stockton Hematology/Oncology
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Louisville
country: United States
facility: Louisville Oncology Clinical Research Program
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: East Providence
country: United States
facility: Pharma Resource
state: Rhode Island
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: De Pintelaan 1885
city: Liege
country: Belgium
facility: CHU de Liege
city: Wilrijk
country: Belgium
facility: GasthuisZusters Antwerpen
city: Bebington
country: United Kingdom
facility: Clatterbridge Centre for Oncology
city: Cardiff
country: United Kingdom
facility: Velindre Hospital
city: Glasgow
country: United Kingdom
facility: Beatson Oncology Center
city: Leed
country: United Kingdom
facility: St James University Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
Study officials:
affiliation: Nektar Therapeutics
name: Alison Hannah, MD
role: STUDY_DIRECTOR
References:
citation: Awada A, Garcia AA, Chan S, Jerusalem GH, Coleman RE, Huizing MT, Mehdi A, O'Reilly SM, Hamm JT, Barrett-Lee PJ, Cocquyt V, Sideras K, Young DE, Zhao C, Chia YL, Hoch U, Hannah AL, Perez EA; NKTR-102 Study Group. Two schedules of etirinotecan pegol (NKTR-102) in patients with previously treated metastatic breast cancer: a randomised phase 2 study. Lancet Oncol. 2013 Nov;14(12):1216-25. doi: 10.1016/S1470-2045(13)70429-7. Epub 2013 Oct 4.