Back to resultsA Rollover Study for Patients Who Received Tremelimumab in Other Protocols, to Allow the Patients Access to Tremelimumab Until This Agent Becomes Commercially Available or Development is Discontinued.
Primary Purpose
Colorectal Neoplasms, Melanoma, Prostatic Neoplasms
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CP-675,206 (Tremelimumab)
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Melanoma and other tumors
Eligibility Criteria
Inclusion Criteria:
- The subject must have already received tremelimumab in another protocol
- Females of childbearing potential must agree to practice a form of effective contraception for 12 months following any dose of study drug. The definition of effective contraception will be based on the judgement of the investigator.
- Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures
Exclusion Criteria:
- None
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Drug: CP-675,206 (Tremelimumab)
Outcomes
Primary Outcome Measures
Safety Endpoints: Serious Adverse Events to Tremelimumab.
Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.
Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.
Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)
Efficacy Endpoints: Survival
Secondary Outcome Measures
Disease Free Survival
Time from the first dose of study drug to the earliest date of evidence of disease (based on tumor status assessment) or death, whichever occurred first
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00378482
Brief Title
A Rollover Study for Patients Who Received Tremelimumab in Other Protocols, to Allow the Patients Access to Tremelimumab Until This Agent Becomes Commercially Available or Development is Discontinued.
Official Title
A Rollover Protocol For Patients Who Received Tremelimumab (CP-675,206 ) In Other Protocols
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2007 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
December 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is intended to provide access to tremelimumab for patients who have previously received tremelimumab in a clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Melanoma, Prostatic Neoplasms, Renal Cell Carcinoma, Neoplasms, Patients Who Have/Have Had Melanoma and Other Tumors
Keywords
Melanoma and other tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Drug: CP-675,206 (Tremelimumab)
Intervention Type
Drug
Intervention Name(s)
CP-675,206 (Tremelimumab)
Other Intervention Name(s)
anti-CTLA4 human monoclonal antibody
Intervention Description
15 mg/kg IV every 3 months as long as required
Primary Outcome Measure Information:
Title
Safety Endpoints: Serious Adverse Events to Tremelimumab.
Time Frame
Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Title
Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.
Time Frame
Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Title
Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.
Time Frame
Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Title
Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)
Time Frame
Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Title
Efficacy Endpoints: Survival
Time Frame
Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Secondary Outcome Measure Information:
Title
Disease Free Survival
Description
Time from the first dose of study drug to the earliest date of evidence of disease (based on tumor status assessment) or death, whichever occurred first
Time Frame
Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject must have already received tremelimumab in another protocol
Females of childbearing potential must agree to practice a form of effective contraception for 12 months following any dose of study drug. The definition of effective contraception will be based on the judgement of the investigator.
Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter Langmuir, Dir.Medic.Science
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Newecastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D4881C00024&attachmentIdentifier=5ab57894-fa70-4755-a7d3-41e1d89888d7&fileName=D4881C00024_SAP_redacted.pdf&versionIdentifier=
Description
Redacted SAP
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D4881C00024&attachmentIdentifier=098db55e-fbbb-4d63-abe9-e79e302970cc&fileName=D4881C00024-csp_redacted.pdf&versionIdentifier=
Description
Redacted CSP
Learn more about this trial
A Rollover Study for Patients Who Received Tremelimumab in Other Protocols, to Allow the Patients Access to Tremelimumab Until This Agent Becomes Commercially Available or Development is Discontinued.
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