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CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00257205
Collaborator
(none)
655
Enrollment
144
Locations
2
Arms
53
Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
655 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: B

Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)

Drug: dacarbazine
decarbazine 1000 mg/m2 IV Q 21 days x 12

Drug: temozolomide
temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12
Experimental: A

Drug: CP-675,206
CP-675,206 15 mg/kg IV Q 90 days x 4
Other Names:
  • anti-CTLA4 human monoclonal antibody

    		•

    Outcome Measures

    Primary Outcome Measures

    1. overall survival [August 2010]

    Secondary Outcome Measures

    1. adverse events [1 year]

    2. PFS at 6 months [6 months]

    3. objective tumor response [1 year]

    4. Durable response [6 months]

    5. pharmacokinetics endpoints [15 months]

    6. pharmacogenomic endpoints [1 year]

    7. HQol [1 year]

    8. healthcare resource utilization and loss of productivity [1 year]

    9. human antihuman antibody response for patients in Arm A [15 months]

    Eligibility Criteria

    Criteria

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

    • Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions.

    • Serum lactic acid dehydrogenase (LDH) <= 2 x ULN

    • ECOG performance status of 0 or 1

    Exclusion Criteria:

    • Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma.

    • History of brain metastases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Huntsville Alabama United States 35805
    2 Research Site Mobile Alabama United States 36607
    3 Research Site Scottsdale Arizona United States 85260
    4 Research Site Little Rock Arkansas United States 72205
    5 Research Site Bakersfield California United States 93309
    6 Research Site Corona California United States 92879
    7 Research Site Fullerton California United States 92835
    8 Research Site Glendora California United States 91741
    9 Research Site Huntington Beach California United States 92648
    10 Research Site Long Beach California United States 90813
    11 Research Site Los Alamitos California United States 90720
    12 Research Site Los Angeles California United States 90095-6970
    13 Research Site Los Angeles California United States 90095
    14 Research Site Oxnard California United States 93030
    15 Research Site Pasadena California United States 91105
    16 Research Site Pomona California United States 91767
    17 Research Site Rancho Cucamonga California United States 91730
    18 Research Site Santa Barbara California United States 93105
    19 Research Site Santa Maria California United States 93454
    20 Research Site West Covina California United States 91790
    21 Research Site Aurora Colorado United States 80045
    22 Research Site Stamford Connecticut United States 06902-3628
    23 Research Site Boynton Beach Florida United States 33426
    24 Research Site Lake Worth Florida United States 33461-4710
    25 Research Site Zion Illinois United States 60099
    26 Research Site Beech Grove Indiana United States 46107
    27 Research Site Indianapolis Indiana United States 46237
    28 Research Site Indianapolis Indiana United States 46260
    29 Research Site Baltimore Maryland United States 21237-3998
    30 Research Site Creve Coeur Missouri United States 63141
    31 Research Site St Louis Missouri United States 63110
    32 Research Site St. Louis Missouri United States 63110
    33 Research Site St. Peters Missouri United States 63376
    34 Research Site Omaha Nebraska United States 68114
    35 Research Site Henderson Nevada United States 89015
    36 Research Site Henderson Nevada United States 89052
    37 Research Site Las Vegas Nevada United States 89109
    38 Research Site Las Vegas Nevada United States 89128
    39 Research Site Las Vegas Nevada United States 89135
    40 Research Site Las Vegas Nevada United States 89148
    41 Research Site Morristown New Jersey United States 07962
    42 Research Site Albany New York United States 12206
    43 Research Site New York New York United States 10016
    44 Research Site Chapel Hill North Carolina United States 27599-7600
    45 Research Site Charlotte North Carolina United States 28203
    46 Research Site Charlotte North Carolina United States 28204
    47 Research Site Canton Ohio United States 44718
    48 Research Site Columbus Ohio United States 43210
    49 Research Site Dover Ohio United States 44718
    50 Research Site Bethlehem Pennsylvania United States 18015
    51 Research Site Pittsburgh Pennsylvania United States 15232
    52 Research Site Dallas Texas United States 75246
    53 Research Site Salt Lake City Utah United States 84112
    54 Research Site Federal Way Washington United States 98003
    55 Research Site Lakewood Washington United States 98499
    56 Research Site Tacoma Washington United States 98405
    57 Research Site Ciudad de Buenos Aires Buenos Aires Argentina C1280AEA
    58 Research Site Waratah New South Wales Australia 2300
    59 Research Site Westmead New South Wales Australia 2145
    60 Research Site Woolloongabba Queensland Australia 4102
    61 Research Site Adelaide South Australia Australia 5000
    62 Research Site Launceston Tasmania Australia 7250
    63 Research Site East Melbourne Victoria Australia 3002
    64 Research Site Wien Austria A-1090
    65 Research Site Brussel Belgium 1090
    66 Research Site Leuven Belgium 3000
    67 Research Site Namur Belgium 5000
    68 Research Site Roeselare Belgium 8800
    69 Research Site Turnhout Belgium 2300
    70 Research Site Wilrijk Belgium 2610
    71 Research Site Yvoir Belgium 5530
    72 Research Site Calgary Alberta Canada T2N 4N2
    73 Research Site Edmonton Alberta Canada T6G 1Z2
    74 Research Site Vancouver British Columbia Canada V5Z 4E6
    75 Research Site Victoria British Columbia Canada V8R 6V5
    76 Research Site Winnipeg Manitoba Canada R3E 0V9
    77 Research Site Hamilton Ontario Canada L8V 5C2
    78 Research Site London Ontario Canada N6A 4L6
    79 Research Site Toronto Ontario Canada M4N 3M5
    80 Research Site Toronto Ontario Canada M5G 2M9
    81 Research Site Windsor Ontario Canada N8W 1L9
    82 Research Site Windsor Ontario Canada N8W 2X3
    83 Research Site Montreal Quebec Canada H2L 4M1
    84 Research Site Quebec Canada G1R 2J6
    85 Research Site Montpellier Cedex 05 France 34280
    86 Research Site Besancon France 25030
    87 Research Site Bordeaux France 33075
    88 Research Site Boulogne France 92104
    89 Research Site Caen France 14033
    90 Research Site Lille France 59000
    91 Research Site Marseille France 13009
    92 Research Site Nantes Cedex 1 France 44035
    93 Research Site Paris France 75010
    94 Research Site Berlin Germany 10117
    95 Research Site Frankfurt Germany 60488
    96 Research Site Hannover Germany 30449
    97 Research Site Kiel Germany 24105
    98 Research Site Tuebingen Germany 72076
    99 Research Site Athens Greece 115 27
    100 Research Site Jerusalem Israel 91120
    101 Research Site Tel Aviv Israel 64239
    102 Research Site Tel Hashomer Israel 52621
    103 Research Site Genova Italy 16132
    104 Research Site Milano Italy 20141
    105 Research Site Napoli Italy 80131
    106 Research Site Padova Italy 35128
    107 Research Site Roma Italy 00144
    108 Research Site Siena Italy 53100
    109 Research Site Mexico DF Mexico 06720
    110 Research Site Mexico DF Mexico 14080
    111 Research Site Groningen GR Netherlands 9713 GZ
    112 Research Site Amsterdam NH Netherlands 1066 CX
    113 Research Site Leiden ZH Netherlands 2311 JS
    114 Research Site Nijmegen Netherlands 6525 GA
    115 Research Site Bialystok Poland 15-027
    116 Research Site Krakow Poland 31-115
    117 Research Site Lubin Poland 59-300
    118 Research Site Poznan Poland 61-866
    119 Research Site Warszawa Poland 02-781
    120 Research Site Obninsk Kaluga Region Russian Federation 249036
    121 Research Site Moscow Russian Federation 115478
    122 Research Site St. Petersburg Russian Federation 197758
    123 Research Site Bratislava Slovakia 833 10
    124 Research Site Cape Town South Africa 7500
    125 Research Site Pretoria South Africa 0181
    126 Research Site Oviedo Asturias Spain 33006
    127 Research Site Hospitalet de Llobregat Barcelona Spain 08907
    128 Research Site Santander Cantabria Spain 39008
    129 Research Site Palma de Mallorca Islas Baleares Spain 07014
    130 Research Site Pamplona Navarra Spain 31008
    131 Research Site Barcelona Spain 08036
    132 Research Site Madrid Spain 28041
    133 Research Site Zaragoza Spain 50009
    134 Research Site Goteborg Sweden 413 45
    135 Research Site Lund Sweden 221 85
    136 Research Site Zurich Switzerland 8091
    137 Research Site Truro Cornwall United Kingdom TR1 3LJ
    138 Research Site Northwood Middlesex United Kingdom HA6 2RN
    139 Research Site Sutton Surrey United Kingdom SM2 5PT
    140 Research Site London United Kingdom SW3 6JJ
    141 Research Site Manchester United Kingdom M20 4BX
    142 Research Site Newcastle upon Tyne United Kingdom NE4 6BE
    143 Research Site Newcastle Upon Tyne United Kingdom NE7 7DN
    144 Research Site Wolverhampton United Kingdom WV10 0QP

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00257205
    Other Study ID Numbers:
    • A3671009
    First Posted:
    Nov 22, 2005
    Last Update Posted:
    Jul 2, 2012
    Last Verified:
    Jun 1, 2012
    Additional relevant MeSH terms:
    Melanoma
    Temozolomide
    Dacarbazine
    Tremelimumab

    Study Results

    No Results Posted as of Jul 2, 2012