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

Sponsor
Peregrine Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01999673
Collaborator
(none)
582
Enrollment
161
Locations
2
Arms
39
Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 1, 2013
Actual Primary Completion Date :
Mar 1, 2017
Actual Study Completion Date :
Mar 1, 2017

Arms and Interventions

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 Names:
  • 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 Names:
  • Taxotere

    • Other: Placebo (for bavituximab)

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [Approximately up to 36 months]

    Secondary Outcome Measures

    1. Progression-free survival [Approximately up to 36 months]

    2. Overall Response Rate [Approximately up to 36 months]

    3. Safety [Approximately up to 36 months]

      As measured by adverse event rates and laboratory evaluations

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Peregrine Pharmaceuticals Investigational Site Huntsville Alabama United States 35805
    2 Peregrine Pharmaceuticals Investigational Site Chandler Arizona United States 85224
    3 Peregrine Pharmaceuticals Investigational Site Glendale Arizona United States 85306
    4 Peregrine Pharmaceuticals Investigational Site Greenbrae California United States 94904
    5 Peregrine Pharmaceuticals Investigational Site Los Angeles California United States 90048
    6 Peregrine Pharmaceuticals Investigational Site Oceanside California United States 92056
    7 Peregrine Pharmaceuticals Investigational Site Orange California United States 92868
    8 Peregrine Pharmaceuticals Investigational Site West Hills California United States 91307
    9 Peregrine Pharmaceuticals Investigational Site Fort Myers Florida United States 33916
    10 Peregrine Pharmaceuticals Investigational Site Saint Petersburg Florida United States 33705
    11 Peregrine Pharmaceuticals Investigational Site Tampa Florida United States 33612
    12 Peregrine Pharmaceuticals Investigational Site Athens Georgia United States 30607
    13 Peregrine Pharmaceuticals Investigational Site Savannah Georgia United States 31404
    14 Peregrine Pharmaceuticals Investigational Site Chicago Illinois United States 60637
    15 Peregrine Pharmaceuticals Investigational Site Indianapolis Indiana United States 46254
    16 Peregrine Pharmaceuticals Investigational Site Marrero Louisiana United States 70006
    17 Peregrine Pharmaceuticals Investigational Site Shreveport Louisiana United States 71101
    18 Peregrine Pharmaceuticals Investigational Site Baltimore Maryland United States 21201
    19 Peregrine Pharmaceuticals Investigational Site Frederick Maryland United States 21701
    20 Peregrine Pharmaceuticals Investigational Site Boston Massachusetts United States 02114
    21 Peregrine Pharmaceuticals Investigational Site Lincoln Nebraska United States 68506
    22 Peregrine Pharmaceuticals Investigational Site Lebanon New Hampshire United States 03756
    23 Peregrine Pharmaceuticals Investigational Site Albuquerque New Mexico United States 87131
    24 Peregrine Pharmaceuticals Investigational Site Winston-Salem North Carolina United States 27103
    25 Peregrine Pharmaceuticals Investigational Site Cincinnati Ohio United States 45242
    26 Peregrine Pharmaceuticals Investigational Site Middletown Ohio United States 45042
    27 Peregrine Pharmaceuticals Investigational Site Portland Oregon United States 97213
    28 Peregrine Pharmaceuticals Investigational Site Hershey Pennsylvania United States 17033
    29 Peregrine Pharmaceuticals Investigational Site Pittsburgh Pennsylvania United States 15232
    30 Peregrine Pharmaceuticals Investigational Site Chattanooga Tennessee United States 37404
    31 Peregrine Pharmaceuticals Investigational Site Knoxville Tennessee United States 37909
    32 Peregrine Pharmaceuticals Investigational Site Nashville Tennessee United States 37203
    33 Peregrine Pharmaceuticals Investigational Site Nashville Tennessee United States 37323
    34 Peregrine Pharmaceuticals Investigational Site Abilene Texas United States 79606
    35 Peregrine Pharmaceuticals Investigational Site Dallas Texas United States 75201
    36 Peregrine Pharmaceuticals Investigational Site Dallas Texas United States 75390
    37 Peregrine Pharmaceuticals Investigational Site Fort Worth Texas United States 76104
    38 Peregrine Pharmaceuticals Investigational Site Temple Texas United States 76508
    39 Peregrine Pharmaceuticals Investigational Site Seattle Washington United States 98108
    40 Peregrine Pharmaceuticals Investigational Site Campbelltown New South Wales Australia 2560
    41 Peregrine Pharmaceuticals Investigational Site Camperdown New South Wales Australia 2050
    42 Peregrine Pharmaceuticals Investigational Site Tweed Heads New South Wales Australia 2485
    43 Peregrine Pharmaceuticals Investigational Site Milton Queensland Australia 4064
    44 Peregrine Pharmaceuticals Investigational Site Redcliffe Queensland Australia 4020
    45 Peregrine Pharmaceuticals Investigational Site Elizabeth Vale South Australia Australia 5112
    46 Peregrine Pharmaceuticals Investigational Site Toorak Gardens South Australia Australia 5065
    47 Peregrine Pharmaceuticals Investigational Site Geelong Victoria Australia 3220
    48 Peregrine Pharmaceuticals Investigational Site Wodonga Victoria Australia 3690
    49 Peregrine Pharmaceuticals Investigational Site Antwerp Belgium 2020
    50 Peregrine Pharmaceuticals Investigational Site Bruxelles Belgium 1000
    51 Peregrine Pharmaceuticals Investigational Site Gent Belgium 9000
    52 Peregrine Pharmaceuticals Investigational Site Herstal Belgium 4040
    53 Peregrine Pharmaceuticals Investigational Site Liege Belgium 4000
    54 Peregrine Pharmaceuticals Investigational Site Mechelen Belgium 2800
    55 Peregrine Pharmaceuticals Investigational Site Namur Belgium 5000
    56 Peregrine Pharmaceuticals Investigational Site Marseille Bouches-du-Rhone France 13273
    57 Peregrine Pharmaceuticals Investigational Site Caen Calvados France 14076
    58 Peregrine Pharmaceuticals Investigational Site Brest Finistere France 29609
    59 Peregrine Pharmaceuticals Investigational Site Nantes Loire-Atlantique France 44202
    60 Peregrine Pharmaceuticals Investigational Site Nancy Meurthe-et-Moselle France 54100
    61 Peregrine Pharmaceuticals Investigational Site Bayonne Pyrenees-Atlantiques France 64100
    62 Peregrine Pharmaceuticals Investigational Site Rennes France 35033
    63 Peregrine Pharmaceuticals Investigational Site Saint Priest en Jarez France 42271
    64 Peregrine Pharmaceuticals Investigational Site Saint-Herblain France 44805
    65 Peregrine Pharmaceuticals Investigational Site Karlsruhe Baden-Wuerttemberg Germany 76137
    66 Peregrine Pharmaceuticals Investigational Site Munchen Bayern Germany 81675
    67 Peregrine Pharmaceuticals Investigational Site Immenhausen Hessen Germany 34376
    68 Peregrine Pharmaceuticals Investigational Site Marburg Hessen Germany 35043
    69 Peregrine Pharmaceuticals Investigational Site Koln Nordrhein-Westfalen Germany 51109
    70 Peregrine Pharmaceuticals Investigational Site Erfurt Thuringia Germany 99089
    71 Peregrine Pharmaceuticals Investigational Site Berlin Germany 12200
    72 Peregrine Pharmaceuticals Investigational Site Berlin Germany 13125
    73 Peregrine Pharmaceuticals Investigational Site Grosshansdorf Germany 22927
    74 Peregrine Pharmaceuticals Investigational Site Halle an der Saale Germany 06120
    75 Peregrine Pharmaceuticals Investigational Site Hamburg Germany 21075
    76 Peregrine Pharmaceuticals Investigational Site Kassel Germany 34125
    77 Peregrine Pharmaceuticals Investigational Site Mainz Germany 55131
    78 Peregrine Pharmaceuticals Investigational Site Munster Germany 48149
    79 Peregrine Pharmaceuticals Investigational Site Villingen-Schwenningen Germany 78052
    80 Peregrine Pharmaceuticals Investigational Site Patras Achaia Greece 26500
    81 Peregrine Pharmaceuticals Investigational Site Neo Faliro Athens Greece 18547
    82 Peregrine Pharmaceuticals Investigational Site Athens Attiki Greece 12464
    83 Peregrine Pharmaceuticals Investigational Site Chania Crete Greece 73300
    84 Peregrine Pharmaceuticals Investigational Site Heraklion Irakleio Greece 71110
    85 Peregrine Pharmaceuticals Investigational Site Thermi Thessaloniki Greece 57001
    86 Peregrine Pharmaceuticals Investigational Site Athens Greece 11527
    87 Peregrine Pharmaceuticals Investigational Site Larissa Greece 41110
    88 Peregrine Pharmaceuticals Investigational Site Thessaloniki Greece 56429
    89 Peregrine Pharmaceuticals Investigational Site Thessaloniki Greece 57010
    90 Peregrine Pharmaceuticals Investigational Site Budapest Hungary 1121
    91 Peregrine Pharmaceuticals Investigational Site Budapest Hungary 1125
    92 Peregrine Pharmaceuticals Investigational Site Gyor Hungary 9023
    93 Peregrine Pharmaceuticals Investigational Site Gyula Hungary 5703
    94 Peregrine Pharmaceuticals Investigational Site Szolnok Hungary 5004
    95 Peregrine Pharmaceuticals Investigational Site Torokbalint Hungary 2045
    96 Peregrine Pharmaceuticals Investigational Site Zalaegerszeg Hungary 8900
    97 Peregrine Pharmaceuticals Investigational Site Meldola Forli-Cesena Italy 47014
    98 Peregrine Pharmaceuticals Investigational Site Lido di Camaiore Lucca Italy 55041
    99 Peregrine Pharmaceuticals Investigational Site Taormina Messina Italy 98039
    100 Peregrine Pharmaceuticals Investigational Site Monza Monza Brianza Italy 20900
    101 Peregrine Pharmaceuticals Investigational Site Aviano Pordenone Italy 33081
    102 Peregrine Pharmaceuticals Investigational Site Bergamo Italy 24127
    103 Peregrine Pharmaceuticals Investigational Site Cremona Italy 26100
    104 Peregrine Pharmaceuticals Investigational Site Genova Italy 16132
    105 Peregrine Pharmaceuticals Investigational Site Milan Italy 20162
    106 Peregrine Pharmaceuticals Investigational Site Turin Italy 10126
    107 Peregrine Pharmaceuticals Investigational Site Suwon Gyeonggi-do Korea, Republic of 443-380
    108 Peregrine Pharmaceuticals Investigational Site Suwon Gyonggi-do Korea, Republic of 442-723
    109 Peregrine Pharmaceuticals Investigational Site Busan Korea, Republic of 602-702
    110 Peregrine Pharmaceuticals Investigational Site Cheongju-si Korea, Republic of 361711
    111 Peregrine Pharmaceuticals Investigational Site Incheon Korea, Republic of 400-711
    112 Peregrine Pharmaceuticals Investigational Site Seongnam Korea, Republic of 463-707
    113 Peregrine Pharmaceuticals Investigational Site Seoul Korea, Republic of 135-710
    114 Peregrine Pharmaceuticals Investigational Site Seoul Korea, Republic of 137-701
    115 Peregrine Pharmaceuticals Investigational Site Seoul Korea, Republic of 156707
    116 Peregrine Pharmaceuticals Investigational Site Brasov Romania 500091
    117 Peregrine Pharmaceuticals Investigational Site Cluj-Napoca Romania 400058
    118 Peregrine Pharmaceuticals Investigational Site Cluj-Napoca Romania 400349
    119 Peregrine Pharmaceuticals Investigational Site Ploiesti Romania 100337
    120 Peregrine Pharmaceuticals Investigational Site Suceava Romania 720237
    121 Peregrine Pharmaceuticals Investigational Site Turda Romania 401103
    122 Peregrine Pharmaceuticals Investigational Site Ekaterinburg Russian Federation 620036
    123 Peregrine Pharmaceuticals Investigational Site Kursk Russian Federation 305035
    124 Peregrine Pharmaceuticals Investigational Site Nizhny Novgorod Russian Federation 603081
    125 Peregrine Pharmaceuticals Investigational Site Obninsk Russian Federation 249036
    126 Peregrine Pharmaceuticals Investigational Site St. Petersburg Russian Federation 194291
    127 Peregrine Pharmaceuticals Investigational Site St. Petersburg Russian Federation 197022
    128 Peregrine Pharmaceuticals Investigational Site St. Petersburg Russian Federation 197758
    129 Peregrine Pharmaceuticals Investigational Site Yaroslavl Russian Federation 150054
    130 Peregrine Pharmaceuticals Investigational Site Badalona Barcelona Spain 08916
    131 Peregrine Pharmaceuticals Investigational Site Hospitalet de Llobregat Barcelona Spain 08908
    132 Peregrine Pharmaceuticals Investigational Site Manresa Barcelona Spain 08243
    133 Peregrine Pharmaceuticals Investigational Site Majadahonda Madrid Spain 28222
    134 Peregrine Pharmaceuticals Investigational Site Pamplona Navarra Spain 31008
    135 Peregrine Pharmaceuticals Investigational Site A Coruna Spain 15006
    136 Peregrine Pharmaceuticals Investigational Site Barcelona Spain 08003
    137 Peregrine Pharmaceuticals Investigational Site Barcelona Spain 08035
    138 Peregrine Pharmaceuticals Investigational Site Barcelona Spain 08041
    139 Peregrine Pharmaceuticals Investigational Site Madrid Spain 28007
    140 Peregrine Pharmaceuticals Investigational Site Madrid Spain 28040
    141 Peregrine Pharmaceuticals Investigational Site Madrid Spain 28041
    142 Peregrine Pharmaceuticals Investigational Site Madrid Spain 28050
    143 Peregrine Pharmaceuticals Investigational Site Malaga Spain 29010
    144 Peregrine Pharmaceuticals Investigational Site Valencia Spain 46017
    145 Peregrine Pharmaceuticals Investigational Site Valencia Spain 46026
    146 Peregrine Pharmaceuticals Investigational Site Kaohsiung City Taiwan 833
    147 Peregrine Pharmaceuticals Investigational Site Putzu Taiwan 613
    148 Peregrine Pharmaceuticals Investigational Site Taichung Taiwan 402
    149 Peregrine Pharmaceuticals Investigational Site Taichung Taiwan 40705
    150 Peregrine Pharmaceuticals Investigational Site Tainan City Taiwan 736
    151 Peregrine Pharmaceuticals Investigational Site Tainan Taiwan 704
    152 Peregrine Pharmaceuticals Investigational Site Taipei Taiwan 100
    153 Peregrine Pharmaceuticals Investigational Site Taipei Taiwan 10449
    154 Peregrine Pharmaceuticals Investigational Site Taipei Taiwan 112
    155 Peregrine Pharmaceuticals Investigational Site Taoyuan Taiwan 333
    156 Peregrine Pharmaceuticals Investigational Site Chernivtsi Ukraine 58013
    157 Peregrine Pharmaceuticals Investigational Site Dnipropetrovsk Ukraine 49102
    158 Peregrine Pharmaceuticals Investigational Site Khmelnytskyi Ukraine 29009
    159 Peregrine Pharmaceuticals Investigational Site Kyiv Ukraine 03115
    160 Peregrine Pharmaceuticals Investigational Site Lutsk Ukraine 43018
    161 Peregrine Pharmaceuticals Investigational Site Uzhgorod Ukraine 88000

    Sponsors and Collaborators

    • Peregrine Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peregrine Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01999673
    Other Study ID Numbers:
    • PPHM 1202
    • 2013-003953-13
    First Posted:
    Dec 3, 2013
    Last Update Posted:
    Apr 21, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by Peregrine Pharmaceuticals
    SUNRISE
    PPHM 1202
    Bavituximab
    Peregrine
    Additional relevant MeSH terms:
    Carcinoma
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Docetaxel
    Bavituximab
    Antibodies, Monoclonal

    Study Results

    No Results Posted as of Apr 21, 2017