Study of CP-675,206 in Refractory Melanoma
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00254579
Collaborator
(none)
251
65
1
48
3.9
0.1
Study Details
Study Description
Brief Summary
CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
251 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Open Label, Single Arm Study To Evaluate The Efficacy, Safety, Tolerability And Pharmacokinetics Of CP-675,206 In Patients With Advanced Refractory And/Or Relapsed Melanoma
Study Start Date
:
Dec 1, 2005
Actual Primary Completion Date
:
Dec 1, 2009
Actual Study Completion Date
:
Dec 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 15 mg/kg CP-675,206
|
Drug: CP-675,206
15 mg/kg Q12W dosing regimen
|
Outcome Measures
Primary Outcome Measures
- To assess the anti-tumor efficacy, as determined by objective response rate, of intravenous CP-675,206 administered at a dose of 15 mg/kg every 90 days to patients with relapsed or refractory advanced melanoma [Tumor response is assessed every 2-3 months until disease progression]
Secondary Outcome Measures
- Safety [At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug]
- Pharmaco Kinetic [At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug]
- Survival [At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug]
- Health-related QoL [At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Surgically incurable Stage III or IV melanoma
-
One prior systemic treatment for metastatic melanoma
-
Measurable disease
-
Eastern Cooperative Oncology Group (ECOG) PS = 0 or 1
Exclusion Criteria:
-
Melanoma of ocular origin
-
Received prior vaccine
-
Received prior CTLA4-inhibiting agent
-
History of, or significant risk for, chronic inflammatory or autoimmune disease
-
Potential requirement for systemic corticosteroids
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Scottsdale | Arizona | United States | 85260 |
| 2 | Research Site | Bentonville | Arkansas | United States | 72712 |
| 3 | Research Site | Fayetteville | Arkansas | United States | 72703 |
| 4 | Research Site | Little Rock | Arkansas | United States | 72205 |
| 5 | Research Site | Los Angeles | California | United States | 90095-6970 |
| 6 | Research Site | Los Angeles | California | United States | 90095 |
| 7 | Research Site | Aurora | Colorado | United States | 80045 |
| 8 | Research Site | Stamford | Connecticut | United States | 06902-3628 |
| 9 | Research Site | Ocoee | Florida | United States | 34761 |
| 10 | Research Site | Orlando | Florida | United States | 32803 |
| 11 | Research Site | Orlando | Florida | United States | 32804 |
| 12 | Research Site | Chicago | Illinois | United States | 60637 |
| 13 | Research Site | Indianapolis | Indiana | United States | 46202 |
| 14 | Research Site | Indianapolis | Indiana | United States | 46237 |
| 15 | Research Site | Indianapolis | Indiana | United States | 46260 |
| 16 | Research Site | Louisville | Kentucky | United States | 40202 |
| 17 | Research Site | Baltimore | Maryland | United States | 21237-3998 |
| 18 | Research Site | Boston | Massachusetts | United States | 02215 |
| 19 | Research Site | Ann Arbor | Michigan | United States | 48109-0946 |
| 20 | Research Site | Buffalo | New York | United States | 14263 |
| 21 | Research Site | New York | New York | United States | 10016 |
| 22 | Research Site | Chapel Hill | North Carolina | United States | 27599-7600 |
| 23 | Research Site | Durham | North Carolina | United States | 27710 |
| 24 | Pfizer Investigational Site | Columbus | Ohio | United States | 43210 |
| 25 | Research Site | Columbus | Ohio | United States | 43210 |
| 26 | Research Site | Bethlehem | Pennsylvania | United States | 18015 |
| 27 | Research Site | Pittsburgh | Pennsylvania | United States | 15232 |
| 28 | Research Site | Nashville | Tennessee | United States | 37232-6307 |
| 29 | Research Site | Nashville | Tennessee | United States | 37232 |
| 30 | Research Site | Salt Lake City | Utah | United States | 84112 |
| 31 | Research Site | Federal Way | Washington | United States | 98003 |
| 32 | Research Site | Lakewood | Washington | United States | 98499 |
| 33 | Research Site | Seattle | Washington | United States | 98104 |
| 34 | Research Site | Seattle | Washington | United States | 98122 |
| 35 | Research Site | Tacoma | Washington | United States | 98405 |
| 36 | Research Site | Madison | Wisconsin | United States | 53792 |
| 37 | Research Site | Ciudad de Buenos Aires | Buenos Aires | Argentina | C1280AEA |
| 38 | Research Site | Waratah | New South Wales | Australia | 2298 |
| 39 | Research Site | Westmead | New South Wales | Australia | 2145 |
| 40 | Research Site | Woolloongabba | Queensland | Australia | 4102 |
| 41 | Research Site | East Melbourne | Victoria | Australia | 3002 |
| 42 | Research Site | Nedlands | Western Australia | Australia | 6009 |
| 43 | Research Site | Hamilton | Ontario | Canada | L8V 5C2 |
| 44 | Research Site | Lille | Cedex | France | 59037 |
| 45 | Research Site | Paris Cedex 13 | France | 75651 | |
| 46 | Research Site | Villejuif | France | 94805 | |
| 47 | Research Site | Berlin | Germany | 10117 | |
| 48 | Research Site | Frankfurt | Germany | 60488 | |
| 49 | Research Site | Kiel | Germany | 24105 | |
| 50 | Research Site | Tuebingen | Germany | 72076 | |
| 51 | Research Site | Meldola, FC | Italy | 47014 | |
| 52 | Research Site | Milano | Italy | 20132 | |
| 53 | Research Site | Milano | Italy | 20133 | |
| 54 | Research Site | Milano | Italy | 20141 | |
| 55 | Research Site | Pamplona | Navarra | Spain | 31008 |
| 56 | Research Site | Barcelona | Spain | 08036 | |
| 57 | Research Site | Madrid | Spain | 28046 | |
| 58 | Research Site | Zaragoza | Spain | 50009 | |
| 59 | Research Site | Truro | Cornwall | United Kingdom | TR1 3LJ |
| 60 | Research Site | Northwood | Middlesex | United Kingdom | HA6 2RN |
| 61 | Research Site | Sutton | Surrey | United Kingdom | SM2 5PT |
| 62 | Research Site | Newcastle upon Tyne | Tyne and Wear | United Kingdom | NE4 6BE |
| 63 | Research Site | London | United Kingdom | SW3 6JJ | |
| 64 | Research Site | Manchester | United Kingdom | M20 4BX | |
| 65 | Research Site | Newcastle Upon Tyne | United Kingdom | NE7 7DN |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00254579
Other Study ID Numbers:
- A3671008
First Posted:
Nov 16, 2005
Last Update Posted:
Jun 7, 2012
Last Verified:
Jun 1, 2012
Keywords provided by AstraZeneca
Additional relevant MeSH terms: