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.

NCT00378482 | Completed Phase 2 Results

• 3 other identifiers: D4881C00024D4881C00024 (A3671024)2008-000989-23
• Study Type: interventional
• Target: 37
• Locations: 2 countries
• Sites: 6

Brief Summary

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

Conditions

Colorectal Neoplasms; Melanoma; Prostatic Neoplasms; Renal Cell Carcinoma; Neoplasms; Patients Who Have/Have Had Melanoma and Other Tumors

Keywords

Melanoma and other tumors

Outcome Measures

Primary Outcomes (5)

• Safety Endpoints: Serious Adverse Events to Tremelimumab.

  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.

• Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.

  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.

• Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.

  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.

• Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)

  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.

• Efficacy Endpoints: Survival

  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 (1)

• Disease Free Survival

  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.

Study Arms (1)

1

EXPERIMENTAL

Drug: CP-675,206 (Tremelimumab)

Drug: CP-675,206 (Tremelimumab)

Interventions

CP-675,206 (Tremelimumab) DRUG

15 mg/kg IV every 3 months as long as required

Also known as: anti-CTLA4 human monoclonal antibody

1

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research Site

Los Angeles, California, 90024, United States

Location

Research Site

Tampa, Florida, 33612, United States

Location

Research Site

Ann Arbor, Michigan, 48109, United States

Location

Research Site

New York, New York, 10016, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

Newecastle Upon Tyne, NE7 7DN, United Kingdom

Location

Related Links

• Redacted SAP
• Redacted CSP
• CSR Synopsis

MeSH Terms

Conditions

Colorectal Neoplasms; Melanoma; Prostatic Neoplasms; Carcinoma, Renal Cell; Neoplasms

Interventions

tremelimumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com

8772409479

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

• Peter Langmuir, Dir.Medic.Science

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2006
• First Posted: September 20, 2006
• Study Start: March 5, 2007
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: August 22, 2024
• Results First Posted: May 28, 2021

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

GB (1); US (5)