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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00312975
First received: April 7, 2006
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Carcinoma, Non-small-cell Lung
Drug: CP-675,206
Drug: best supportive care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 months to 2 years from randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Levels of study drug in blood samples taken at specified time points. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Whether polymorphisms of certain genes influence safety. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Health-related quality of life outcomes. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Tumor response [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Number of patients with adverse events as a measure of safety of CP-675,206 when administered to patients with NSCLC [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Blood levels of any human anti-human antibody response [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Immune response. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Efficacy [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: May 2006
Study Completion Date: February 2010
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312975

  Hide Study Locations
Locations
United States, Arkansas
Research Site
Bentonville, Arkansas, United States, 72712
Research Site
Fayetteville, Arkansas, United States, 72703
United States, California
Research Site
Orange, California, United States, 92868
United States, Connecticut
Research Site
Danbury, Connecticut, United States, 06810
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30309
United States, Kentucky
Research Site
Lexington, Kentucky, United States, 40536-0098
United States, Louisiana
Research Site
Alexandria, Louisiana, United States, 71301
United States, New York
Research Site
New York, New York, United States, 10032
Research Site
Oneida, New York, United States, 13421
Research Site
Oswego, New York, United States, 13126
Research Site
Syracuse, New York, United States, 13202
Research Site
Syracuse, New York, United States, 13210-2306
United States, Ohio
Research Site
Canton, Ohio, United States, 44718
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19111
Canada, Alberta
Research Site
Calgary, Alberta, Canada, T2N 4N2
Research Site
Calgary, Alberta, Canada, T2S 3C3
Research Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H3T 1E2
Czech Republic
Research Site
Praha 8, Czech Republic, 180 81
Research Site
Tabor, Czech Republic, 390 03
Research Site
Usti nad Labem, Czech Republic, 401 13
Korea, Republic of
Research Site
Seoul, Korea, Republic of, 110-744
Research Site
Seoul, Korea, Republic of, 135-710
Research Site
Seoul, Korea, Republic of, 137-701
United Kingdom
Research Site
Southampton, Hampshire, United Kingdom, SO16 6YD
Research Site
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00312975     History of Changes
Other Study ID Numbers: A3671015
Study First Received: April 7, 2006
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Tremelimumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014