Clincosm LogoSign in Get a demo

Randomized Study Of CP-675,206 or Best Supportive Care Immediately After Platinum-Based Therapy For Non-Small Cell Lung Cancer (NSCLC)

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00312975
Collaborator
(none)
90
Enrollment
26
Locations
2
Arms
45.1
Duration (Months)
3.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to study how long patients can remain progression free when they receive CP-675,206, compared to how long patients can remain progression free when they receive best supportive care. If you choose to take part, you will be randomized to receive either CP-675,206 as maintenance therapy or best supportive care. Best supportive care means you will not receive any study drug or other treatment for your cancer. Best supportive care could include treatment with antibiotics, analgesic drugs (medicine for pain), blood transfusions or psychosocial and nutritional support, depending on your needs. You have a 50% chance of being randomized to receive CP-675,206.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2 Randomized, Non-Comparative Study Of CP-675,206 Or Best Supportive Care Immediately Following First-Line, Platinum-Based Therapy In Patients With Stage IIIB (With Effusion) Or Stage IV Non-Small Cell Lung Cancer That Has Responded Or Remained Stable
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

Drug: CP-675,206
Given intravenously every 3 months
Active Comparator: Arm B

Drug: best supportive care
As per investigator discretion. Excludes chemotherapy or other anti-cancer therapy

Outcome Measures

Primary Outcome Measures

  1. The length of time until there is evidence of disease progression in patients treated with CP-675,206 and in patients receiving best supportive care. [3 months to 2 years from randomization]

Secondary Outcome Measures

  1. Survival [2 years]

  2. Levels of study drug in blood samples taken at specified time points. [up to 2 years]

  3. Whether polymorphisms of certain genes influence safety. [up to 2 years]

  4. Health-related quality of life outcomes. [up to 2 years]

  5. Tumor response [up to 2 years]

  6. Number of patients with adverse events as a measure of safety of CP-675,206 when administered to patients with NSCLC [up to 2 years]

  7. Blood levels of any human anti-human antibody response [up to 2 years]

  8. Immune response. [up to 2 years]

  9. Efficacy [up to 2 years]

Eligibility Criteria

Criteria

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

  • Stage IIIb (with effusion) or stage IV disease that has responded or remained stable after 6 cycles of a platinum containing 1st-line regimen

  • Patients must be able to be randomized between 3 and no more than 6 weeks after the last dose of first-line therapy.

Exclusion Criteria:

  • No other systemic therapy except 1st-line platinum based treatment

  • Symptomatic or uncontrolled brain mets or uncontrolled pleural effusions.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Bentonville Arkansas United States 72712
2 Research Site Fayetteville Arkansas United States 72703
3 Research Site Orange California United States 92868
4 Research Site Danbury Connecticut United States 06810
5 Research Site Atlanta Georgia United States 30309
6 Research Site Lexington Kentucky United States 40536-0098
7 Research Site Alexandria Louisiana United States 71301
8 Research Site New York New York United States 10032
9 Research Site Oneida New York United States 13421
10 Research Site Oswego New York United States 13126
11 Research Site Syracuse New York United States 13202
12 Research Site Syracuse New York United States 13210-2306
13 Research Site Canton Ohio United States 44718
14 Research Site Philadelphia Pennsylvania United States 19111
15 Research Site Calgary Alberta Canada T2N 4N2
16 Research Site Calgary Alberta Canada T2S 3C3
17 Research Site Edmonton Alberta Canada T6G 1Z2
18 Research Site Montreal Quebec Canada H3T 1E2
19 Research Site Praha 8 Czech Republic 180 81
20 Research Site Tabor Czech Republic 390 03
21 Research Site Usti nad Labem Czech Republic 401 13
22 Research Site Seoul Korea, Republic of 110-744
23 Research Site Seoul Korea, Republic of 135-710
24 Research Site Seoul Korea, Republic of 137-701
25 Research Site Southampton Hampshire United Kingdom SO16 6YD
26 Research Site London United Kingdom SE1 9RT

Sponsors and Collaborators

  • AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00312975
Other Study ID Numbers:
  • A3671015
First Posted:
Apr 11, 2006
Last Update Posted:
Jun 7, 2012
Last Verified:
Jun 1, 2012
Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Tremelimumab

Study Results

No Results Posted as of Jun 7, 2012