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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01999673
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
Peregrine Pharmaceuticals

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 582 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Previously Treated Stage IIIb/IV Non-Squamous Non Small-Cell Lung Cancer
Study Start Date : December 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Approximately up to 36 months ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Approximately up to 36 months ]
  2. Overall Response Rate [ Time Frame: Approximately up to 36 months ]
  3. Safety [ Time Frame: Approximately up to 36 months ]
    As measured by adverse event rates and laboratory evaluations


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999673


Locations
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Sponsors and Collaborators
Peregrine Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01999673    
Other Study ID Numbers: PPHM 1202
2013-003953-13 ( EudraCT Number )
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017
Keywords provided by Peregrine Pharmaceuticals:
SUNRISE
PPHM 1202
Bavituximab
Peregrine
Additional relevant MeSH terms:
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Bavituximab
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antibodies, Monoclonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immunologic Factors
Physiological Effects of Drugs