Clinical trial NCT00378482: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Melanoma
Prostatic Neoplasms
Renal Cell Carcinoma
Neoplasms
Patients Who Have/Have Had Melanoma and Other Tumors
Keywords: Melanoma and other tumors
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-09-20
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is intended to provide access to tremelimumab for patients who have previously received tremelimumab in a clinical trial.


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

Primary outcomes:
measure: Safety Endpoints: Serious Adverse Events to Tremelimumab.
timeFrame: 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.
measure: Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.
timeFrame: 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.
measure: Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.
timeFrame: 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.
measure: Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)
timeFrame: 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.
measure: Efficacy Endpoints: Survival
timeFrame: 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 outcomes:
measure: Disease Free Survival
timeFrame: 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.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: New York
country: United States
facility: Research Site
state: New York
city: Houston
country: United States
facility: Research Site
state: Texas
city: Newecastle Upon Tyne
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Peter Langmuir, Dir.Medic.Science
role: STUDY_DIRECTOR
References: