Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer (SUNRISE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Peregrine Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01999673
First received: November 25, 2013
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.


Condition Intervention Phase
Non-Small-Cell Lung Cancer Stage IIIB
Non-Small-Cell Lung Cancer Stage IV
Non-Small-Cell Lung Cancer Metastatic
Carcinoma, Non-Small-Cell Lung
Non-Small Cell Lung Cancer
Non-Small-Cell Lung Carcinoma
Nonsmall Cell Lung Cancer
Biological: bavituximab
Drug: Docetaxel
Other: Placebo (for bavituximab)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel Versus Docetaxel Alone as Second-Line Therapy in Patients With Stage IIIb/IV Non-Squamous Non Small-Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Approximately up to 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Approximately up to 36 months ] [ Designated as safety issue: No ]
  • Overall Response Rate [ Time Frame: Approximately up to 36 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Approximately up to 36 months ] [ Designated as safety issue: Yes ]
    As measured by adverse event rates and laboratory evaluations


Estimated Enrollment: 582
Study Start Date: December 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bavituximab plus docetaxel
Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression.
Biological: bavituximab Drug: Docetaxel
Other Name: Taxotere
Placebo Comparator: placebo plus docetaxel
Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression.
Drug: Docetaxel
Other Name: Taxotere
Other: Placebo (for bavituximab)

  Eligibility

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

Key Inclusion Criteria:

  • Male or female at least 18 years of age
  • Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual (7th Edition)
  • Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy. For patients with known epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK) translocations, appropriate targeted treatment should have been used. Mutation testing is not required.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic, renal and hepatic function

Exclusion Criteria:

  • Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC
  • Known history of bleeding disorders, eg, von Willebrand disease or hemophilia
  • Cavitary tumors or tumors invading or abutting large blood vessels
  • Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within the 6 months before screening
  • Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening
  • Grade 2 or higher peripheral neuropathy
  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: NCT01999673

Contacts
Contact: Jennifer Lai, MBA 1-855-291-SUNR (7867) lungcancertrial@peregrineinc.com

  Show 144 Study Locations
Sponsors and Collaborators
Peregrine Pharmaceuticals
  More Information

No publications provided

Responsible Party: Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01999673     History of Changes
Other Study ID Numbers: PPHM 1202, 2013-003953-13
Study First Received: November 25, 2013
Last Updated: October 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Peregrine Pharmaceuticals:
SUNRISE
PPHM 1202
Bavituximab
bavituximab

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Docetaxel
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014