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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802945
• Other study ID #: 08-PIR-05
• Status: Completed
• Phase: Phase 2
• Start date: October 2008
• Est. completion date: January 2012

Study information

• Verified date: June 2018
• Source: Nektar Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Tumor

Intervention

Drug:
• NKTR-102
NKTR-102 given on a q14 day schedule
• NKTR-102
NKTR-102 given on a q21 day schedule

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Bruxelles
Belgium	UZ Antwerpen	Edegem
Belgium	De Pintelaan 1885	Gent
Belgium	CHU de Liege	Liege
Belgium	GasthuisZusters Antwerpen	Wilrijk
United Kingdom	Clatterbridge Centre for Oncology	Bebington
United Kingdom	Velindre Hospital	Cardiff
United Kingdom	Beatson Oncology Center	Glasgow
United Kingdom	St James University Hospital	Leed
United Kingdom	Nottingham City Hospital	Nottingham
United Kingdom	Weston Park Hospital	Sheffield
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Pharma Resource	East Providence	Rhode Island
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California
United States	Louisville Oncology Clinical Research Program	Louisville	Kentucky
United States	Desert Hematology Oncology Medical Group	Rancho Mirage	California
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Stockton Hematology/Oncology	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
Nektar Therapeutics

Countries where clinical trial is conducted

United States,  Belgium,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	Up to 2 years.
Secondary	Kaplan Meier Estimate of Progression-Free Survival (PFS)	Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.	Up to 2 years.
Secondary	Kaplan Meier Estimate of Overall Survival (OS)	OS was calculated as the time from the date of first study drug administration until death from any cause. Subjects alive at the time of analysis were censored at the time they were last known alive. OS was analyzed for the ITT population.	Up to 2 years.
Secondary	Kaplan Meier Estimate of 6-month Survival	Six-month survival (i.e., overall survival proportion at 6 months) was estimated using Kaplan Meier method. The analyses were performed in the ITT population.	From Cycle 1 Day 1 to the end of 6 months.
Secondary	Kaplan Meier Estimate of 1-year Survival	One year survival (i.e., overall survival proportion at 12 months) was estimated using Kaplan Meier method. The analyses were performed in the ITT population.	From Cycle 1 Day 1 to the end of 12 months.
Secondary	Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate = 2% in Either Treatment Group	An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. TEAE was any event not present before exposure to the study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug. All AEs were assessed for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0. If a particular AE was not listed in the NCI CTCAE Version 3.0, the following criteria were used: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life threatening or disabling; Grade 5 = Death.	Up to 2 years.