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| ID | Type | Description | Link |
|---|---|---|---|
| D4881C00024 (A3671024) | Other Identifier | AZ study code | |
| 2008-000989-23 | EudraCT Number |
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This study is intended to provide access to tremelimumab for patients who have previously received tremelimumab in a clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Drug: CP-675,206 (Tremelimumab) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-675,206 (Tremelimumab) | Drug | 15 mg/kg IV every 3 months as long as required |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Peter Langmuir, Dir.Medic.Science | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angeles | California | 90024 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| Redacted SAP | View source |
| Redacted CSP | View source |
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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
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.
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.
Total Consented/screened 38 subjects (1 of which was dead before enter any treatment), so total entered treatment 37 subjects. Subjects were assigned to treatment if they met all inclusion. 32 subjects withdrawn from this study. 6 subjects completed the study.
Final Efficacy/Safety analysis 37 subjects.
First subject enrolled: 05 Mar 2007; Data Cut-off: 18 Jun 2020. This was a multicenter study conducted at 11 study centers in 3 countries (the United Kingdom, the United States of America and Italy).
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| ID | Title | Description |
|---|---|---|
| FG000 | Tremelimumab 15mg/kg | All Patients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 26, 2019 | Jan 15, 2021 |
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| Tampa |
| Florida |
| 33612 |
| United States |
| Research Site | Ann Arbor | Michigan | 48109 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Newecastle Upon Tyne | NE7 7DN | United Kingdom |
| CSR Synopsis | View source |
| COMPLETED | 6 |
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| NOT COMPLETED |
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One participant received no study medication and was excluded from data analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Tremelimumab 15mg/kg | All Patients |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety Endpoints: Serious Adverse Events to Tremelimumab. | 37 Participants received study treatment | Posted | Count of Participants | Participants | 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. |
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| Primary | Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab. | 37 Participants received study treatment | Posted | Count of Participants | Participants | 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. |
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| Primary | Safety Endpoints: Hypersensitivity Reactions to Tremelimumab. | 37 Participants received study treatment | Posted | Count of Participants | Participants | 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. |
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| Primary | Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED) | Treated patients with response assessed | Posted | Count of Participants | Participants | 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. |
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| Primary | Efficacy Endpoints: Survival | Treated patients with response assessed | Posted | Count of Participants | Participants | 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. |
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| Secondary | 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 | Treated patients | Posted | Median | 95% Confidence Interval | Days | 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. |
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13 years, 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tremelimumab 15mg/kg | All Patients | 11 | 37 | 4 | 37 | 5 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Medical Device Complication | General disorders | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
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| Sepsis | Infections and infestations | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Pulmonary Granuloma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Non-systematic Assessment |
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Sponsor can review results communications prior to public release and can embargo regarding trial results for up to six (6) months from the time submitted to the sponsor for review. All reasonable comments made by the sponsor in relation to the publication will be incorporated into the publication. PI shall not unreasonable withhold or delay its consent to a request from the sponsor for an exceptional additional delay if in the reasonable opinion of the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca Clinical Study Information Center | 8772409479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 17, 2020 | Jan 15, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D008545 | Melanoma |
| D011471 | Prostatic Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C520704 | tremelimumab |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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