Phase 2 N=70 Randomized Treatment

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

Tumor · Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00802945 ↗

Enrolled (actual)

Serious AEs

47.1%

Results posted

Jul 2018

Primary outcome: Primary: Objective Response Rate (ORR) — 28.6; 35 percentage of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: NKTR-102 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Nektar Therapeutics
Primary completion: Oct 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response Rate (ORR)	28.6; 35	—
SECONDARY Kaplan Meier Estimate of Progression-Free Survival (PFS)	3.3; 5.6	—
SECONDARY Kaplan Meier Estimate of Overall Survival (OS)	8.8; 13.1	—
SECONDARY Kaplan Meier Estimate of 6-month Survival	57.1; 82.9	—
SECONDARY Kaplan Meier Estimate of 1-year Survival	42.9; 51.4	—
SECONDARY Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group	68.6; 54.3; 20.0; 22.9; 5.7; 2.9	—

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00802945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.