A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Nektar Therapeutics
Study ID
NCT02915744
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NKTR-102 — DRUG
  • Eribulin — DRUG
  • Ixabepilone — DRUG
  • Vinorelbine — DRUG
  • Gemcitabine — DRUG
  • Paclitaxel — DRUG
  • Docetaxel — DRUG
  • Nab-paclitaxel — DRUG

Study Details

This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient).

Key Dates

Start date
Nov 30, 2016
Status verified
Apr 2023
Primary completion
Jul 31, 2020
Completion
Jul 31, 2020

Study Design

Enrollment
178 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NKTR-102
    In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.
  • Active Comparator: Treatment of Physician's Choice (TPC)
    In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.

Primary Outcome Measure

Overall Survival (OS) of Patients [ Time Frame: Within 3 years from study start ]

Locations (19)

FacilityCityStateZIPSite coordinators
Investigator Site - TucsonTucsonArizona85724-
Investigator Site - OrangeOrangeCalifornia92868-
Investigator Site - San FranciscoSan FranciscoCalifornia94115-
Investigator Site - MiamiMiamiFlorida33136-
Investigator Site - PlantationPlantationFlorida33324-
Investigator Site - West Palm BeachWest Palm BeachFlorida33401-
Investigator Site - AthensAthensGeorgia30607-
Investigator Site - BaltimoreBaltimoreMaryland21201-
Investigator Site - BostonBostonMassachusetts02115-
Investigator Site - MinneapolisMinneapolisMinnesota55455-
Investigator Site - Saint LouisSt LouisMissouri63110-
Investigator Site - New YorkNew YorkNew York10065-
Investigator Site - Chapel HillChapel HillNorth Carolina27599-
Investigator Site - ColumbusColumbusOhio43210-
Investigator Site - GermantownGermantownTennessee38138-
Investigator Site - Fort WorthFort WorthTexas76104-
Investigator Site - HoustonHoustonTexas77030-
Investigator Site - Salt Lake CitySalt Lake CityUtah84106-
Investigator Site - SeattleSeattleWashington98109-

Find similar trials in Tucson, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Investigator Site - Tucson· Tucson, AZInvestigator Site - Orange· Orange, CAInvestigator Site - San Francisco· San Francisco, CAInvestigator Site - Miami· Miami, FLInvestigator Site - Plantation· Plantation, FLInvestigator Site - West Palm Beach· West Palm Beach, FL

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