Trial Outcomes & Findings for 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. (NCT NCT00378482)
NCT ID: NCT00378482
Last Updated: 2024-08-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome 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.
Results posted on
2024-08-22
Participant Flow
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).
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 Subjects were assigned to treatment if they met all inclusion. 32 subjects withdrawn from this study. 6 subjects completed the study.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.
Participant milestones
| Measure |
Tremelimumab 15mg/kg
All Patients
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Tremelimumab 15mg/kg
All Patients
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Lack of Efficacy
|
8
|
|
Overall Study
Subject or physician decision, or subject relocation to another city or region.
|
9
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Adverse Event
|
9
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Tremelimumab 15mg/kg
n=37 Participants
All Patients
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
PRIMARY outcome
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.Population: 37 Participants received study treatment
Outcome measures
| Measure |
Tremelimumab 15mg/kg
n=37 Participants
All Patients
|
|---|---|
|
Safety Endpoints: Serious Adverse Events to Tremelimumab.
Number of Participants with SAE to tremelimumab
|
4 Participants
|
|
Safety Endpoints: Serious Adverse Events to Tremelimumab.
Number of Participants with no SAE to tremelimumab
|
33 Participants
|
PRIMARY outcome
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.Population: 37 Participants received study treatment
Outcome measures
| Measure |
Tremelimumab 15mg/kg
n=37 Participants
All Patients
|
|---|---|
|
Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.
Number of participants with Grade 3 or 4 tremelimumab-related adverse events to tremelimumab
|
4 Participants
|
|
Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.
Number of participants with no Grade 3 or 4 tremelimumab-related adverse events to tremelimumab
|
33 Participants
|
PRIMARY outcome
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.Population: 37 Participants received study treatment
Outcome measures
| Measure |
Tremelimumab 15mg/kg
n=37 Participants
All Patients
|
|---|---|
|
Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.
Number of participants with Hypersensitivity reactions to tremelimumab
|
6 Participants
|
|
Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.
Number of participants with no Hypersensitivity reactions to tremelimumab
|
31 Participants
|
PRIMARY outcome
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.Population: Treated patients with response assessed
Outcome measures
| Measure |
Tremelimumab 15mg/kg
n=37 Participants
All Patients
|
|---|---|
|
Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)
No evidence of disease
|
19 Participants
|
|
Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)
Evidence of disease
|
17 Participants
|
|
Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)
Indeterminate
|
1 Participants
|
PRIMARY outcome
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.Population: Treated patients with response assessed
Outcome measures
| Measure |
Tremelimumab 15mg/kg
n=37 Participants
All Patients
|
|---|---|
|
Efficacy Endpoints: Survival
Death
|
10 Participants
|
|
Efficacy Endpoints: Survival
Censored
|
27 Participants
|
SECONDARY outcome
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.Population: Treated patients
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
Outcome measures
| Measure |
Tremelimumab 15mg/kg
n=37 Participants
All Patients
|
|---|---|
|
Disease Free Survival
|
3.0 Days
Interval 2.9 to 11.8
|
Adverse Events
Tremelimumab 15mg/kg
Serious events: 4 serious events
Other events: 5 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Tremelimumab 15mg/kg
n=37 participants at risk
All Patients
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
1/37 • Number of events 1 • 13 years, 3 months
|
|
General disorders
Medical Device Complication
|
2.7%
1/37 • Number of events 1 • 13 years, 3 months
|
|
Hepatobiliary disorders
Cholecystitis
|
2.7%
1/37 • Number of events 1 • 13 years, 3 months
|
|
Infections and infestations
Sepsis
|
2.7%
1/37 • Number of events 1 • 13 years, 3 months
|
|
Infections and infestations
Urinary Tract Infection
|
2.7%
1/37 • Number of events 1 • 13 years, 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.7%
1/37 • Number of events 1 • 13 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Granuloma
|
2.7%
1/37 • Number of events 1 • 13 years, 3 months
|
Other adverse events
| Measure |
Tremelimumab 15mg/kg
n=37 participants at risk
All Patients
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
10.8%
4/37 • Number of events 12 • 13 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.1%
3/37 • Number of events 3 • 13 years, 3 months
|
|
Endocrine disorders
Hypothyroidism
|
5.4%
2/37 • Number of events 2 • 13 years, 3 months
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical Study Information Center
Phone: 8772409479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER