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The BEACON Study (Breast Cancer Outcomes With NKTR-102)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT01492101
First received: December 12, 2011
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.

The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.


Condition Intervention Phase
Locally Recurrent Breast Cancer
Metastatic Breast Cancer
Drug: NKTR-102
Drug: Treatment of Physician's Choice (TPC)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The BEACON Study (Breast Cancer Outcomes With NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Locally Recurrent or Metastatic Breast Cancer Previously Treated With an Anthracycline, a Taxane and Capecitabine

Resource links provided by NLM:


Further study details as provided by Nektar Therapeutics:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
    To compare overall survival (OS) of patients who received NKTR-102 given once every 21 days (q21d) to patients who received Treatment of Physicians Choice (TPC) selected from the following list of seven single agent intravenous therapies: eribulin, ixabepilone,vinorelbine, gemcitabine, paclitaxel, docetaxel or nab-paclitaxel


Estimated Enrollment: 840
Study Start Date: December 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NKTR-102 Drug: NKTR-102
145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
Active Comparator: Physician's Treatment of Choice Drug: Treatment of Physician's Choice (TPC)

One of the following Treatment of Physician Choice will be administered per standard of care:

eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (major highlights):

  • Patient is an adult female with histologically or cytologically confirmed carcinoma of the breast for whom single-agent cytotoxic chemotherapy is indicated
  • Patient can have either measurable or non-measurable disease by RECIST.
  • Patient has received prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, a taxane and capecitabine
  • Patient has minimum of 2 and a maximum of 5 prior cytotoxic chemotherapy regimens with the last dose administered within 6 months. A minimum of two chemotherapy regimens had to be for locally recurrent and/or metastatic disease. All therapy received prior to a diagnosis of metastatic disease (eg, neoadjuvant, adjuvant or repeated adjuvant therapy following a second resection) is counted as one regimen.
  • Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate hematopoietic, liver and kidney functions.

Exclusion Criteria (major highlights):

  • Patient with chemotherapy within 21 days, radiotherapy within 14 days, biological therapy with 14 days, hormonal therapy within 7 days and investigational therapy within 21 days prior to randomization.
  • Patient with any major surgery within 28 days prior to randomization.
  • Patient with concurrent use of biologic agents for the treatment of cancer including antibodies or any investigational agent(s).
  • Patient with prior treatment for cancer with a camptothecin derivative.
  • Patient with chronic or acute GI disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care to control diarrhea in the 28 days prior to randomization.
  • Patient received pharmacotherapy for hepatitis B or C, tuberculosis or HIV.
  • Patient with known cirrhosis diagnosed with Child-PUGH Class A or higher liver disease.
  • Patient with prior malignancy (other than breast cancer) except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 5 years prior to randomization.
  • Patient requiring daily use of oxygen supplementation in the 28 days prior to randomization.
  • Patients with significant cardiovascular impairment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492101

  Show 153 Study Locations
Sponsors and Collaborators
Nektar Therapeutics
Investigators
Study Director: Ivan Gergel, MD Nektar Therapeutics
  More Information

No publications provided

Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT01492101     History of Changes
Other Study ID Numbers: 11-PIR-11
Study First Received: December 12, 2011
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 23, 2014