Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00363051
First received: August 2, 2006
Last updated: May 6, 2013
Last verified: May 2013
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Results First Received: December 2, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Conditions: |
Islet Cell Carcinoma Neuroendocrine Carcinoma Neuroendocrine Tumor Pancreatic Neoplasms |
| Interventions: |
Drug: Everolimus 10 mg Drug: Octreotide Depot |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Stratum 1: Everolimus 10 mg | Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
| Stratum 2: Everolimus 10 mg + Octreotide Depot |
Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
Participant Flow: Overall Study
| Stratum 1: Everolimus 10 mg | Stratum 2: Everolimus 10 mg + Octreotide Depot | |
|---|---|---|
| STARTED | 115 | 45 |
| COMPLETED | 77 [1] | 23 |
| NOT COMPLETED | 38 | 22 |
| Adminstrative problems | 1 | 1 |
| Adverse Event | 21 | 12 |
| New Cancer Therapy | 2 | 1 |
| Withdrawal by Subject | 11 | 3 |
| Lost to Follow-up | 0 | 1 |
| Protocol Violation | 0 | 2 |
| Death | 3 | 2 |
| [1] | Patients with documented disease progression per RECIST criteria |
|---|
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Stratum 1: Everolimus 10 mg | Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
| Stratum 2: Everolimus 10 mg + Octreotide Depot | Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot. |
| Total | Total of all reporting groups |
Baseline Measures
| Stratum 1: Everolimus 10 mg | Stratum 2: Everolimus 10 mg + Octreotide Depot | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
115 | 45 | 160 |
|
Age
[units: years] Mean ± Standard Deviation |
55.1 ± 11.8 | 53.64 ± 12.478 | 54.33 ± 11.98 |
|
Gender
[units: participants] |
|||
| Female | 49 | 21 | 70 |
| Male | 66 | 24 | 90 |
Outcome Measures
| 1. Primary: | Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST) |
| Measure Description | Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions. |
| Time Frame | from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months) |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus. |
Reporting Groups
| Description | |
|---|---|
| Stratum 1: Everolimus 10 mg | Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
Measured Values
| Stratum 1: Everolimus 10 mg | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
115 |
|
Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
[units: percentage of participants] Number ( 95% Confidence Interval ) |
9.6
( 4.9 to 16.5 ) |
No statistical analysis provided for Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
| 2. Secondary: | Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review [ Time Frame: from date of first documented confirmed response to time to progression, at least 3 months ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review |
| Measure Description |
Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):
Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions |
| Time Frame | from date of first documented confirmed response to time to progression, at least 3 months |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus. Only those patients whose best overall response was complete response (CR) or partial response (PR) were included in this analysis. |
Reporting Groups
| Description | |
|---|---|
| Stratum 1: Everolimus 10 mg | Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
Measured Values
| Stratum 1: Everolimus 10 mg | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
11 |
|
Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
[units: Months] Median ( 95% Confidence Interval ) |
10.64
( 9.79 to NA ) [1] |
| [1] | The upper limit was not estimable in the study as it is longer than duration of study. |
|---|
No statistical analysis provided for Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
| 3. Secondary: | Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review [ Time Frame: from date of first documented confirmed response to time to progression, at least 3 months ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review |
| Measure Description |
Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):
Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions |
| Time Frame | from date of first documented confirmed response to time to progression, at least 3 months |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Very low number of patients demonstrated a partial response, the median duration of response as per central review has not been calculated. |
Reporting Groups
| Description | |
|---|---|
| Stratum 2: Everolimus 10 mg + Octreotide Depot |
Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
Measured Values
| Stratum 2: Everolimus 10 mg + Octreotide Depot | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
0 |
| Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review |
No statistical analysis provided for Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
| 4. Secondary: | Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: from date of randomization/start of treatment until first documented response confirmed 4 weeks later (at least 3 months) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST) |
| Measure Description | Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions. |
| Time Frame | from date of randomization/start of treatment until first documented response confirmed 4 weeks later (at least 3 months) |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Full Analysis Set (FAS) was consisted of all patients who received at least one dose of everolimus. |
Reporting Groups
| Description | |
|---|---|
| Stratum 2: Everolimus 10 mg + Octreotide Depot |
Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
Measured Values
| Stratum 2: Everolimus 10 mg + Octreotide Depot | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
45 |
|
Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
[units: percentage of participants] Number ( 95% Confidence Interval ) |
4.4
( 0.5 to 15.1 ) |
No statistical analysis provided for Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
| 5. Secondary: | Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1] [ Time Frame: on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1] |
| Measure Description | Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. |
| Time Frame | on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month |
| Safety Issue | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment. |
Reporting Groups
| Description | |
|---|---|
| Stratum 1: Everolimus 10 mg | Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
Measured Values
| Stratum 1: Everolimus 10 mg | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
115 |
|
Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1]
[units: Participants] |
|
| Adverse Events | 115 |
| Death | 10 |
| Serious Adverse Events | 63 |
No statistical analysis provided for Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1]
| 6. Secondary: | Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2] [ Time Frame: on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2] |
| Measure Description | Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. |
| Time Frame | on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month |
| Safety Issue | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment. |
Reporting Groups
| Description | |
|---|---|
| Stratum 2: Everolimus 10 mg + Octreotide Depot | Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot. |
Measured Values
| Stratum 2: Everolimus 10 mg + Octreotide Depot | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
45 |
|
Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2]
[units: Participants] |
|
| Adverse Events | 45 |
| Death | 2 |
| Serious Adverse Events | 27 |
No statistical analysis provided for Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2]
| 7. Secondary: | Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1) [ Time Frame: from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1) |
| Measure Description |
Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed. Median PFS was obtained and displayed along with 95% confidence intervals. |
| Time Frame | from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus. |
Reporting Groups
| Description | |
|---|---|
| Stratum 1: Everolimus 10 mg | Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
Measured Values
| Stratum 1: Everolimus 10 mg | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
115 |
|
Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1)
[units: Months] Median ( 95% Confidence Interval ) |
9.69
( 8.25 to 13.31 ) |
No statistical analysis provided for Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1)
| 8. Secondary: | Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2) [ Time Frame: from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2) |
| Measure Description |
Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed. Median PFS was obtained and displayed along with 95% confidence intervals. |
| Time Frame | from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus. |
Reporting Groups
| Description | |
|---|---|
| Stratum 2: Everolimus 10 mg + Octreotide Depot | Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot. |
Measured Values
| Stratum 2: Everolimus 10 mg + Octreotide Depot | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
45 |
|
Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2)
[units: Months] Median ( 95% Confidence Interval ) |
16.69
( 11.07 to NA ) [1] |
| [1] | The upper limit was not estimable in the study as it is longer than duration of study. |
|---|
No statistical analysis provided for Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2)
| 9. Secondary: | Time to Overall Survival (OS)(Stratum 1) [ Time Frame: from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Time to Overall Survival (OS)(Stratum 1) |
| Measure Description |
Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed. |
| Time Frame | from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The full analysis set consisted of all patients who received at least one dose of everolimus. |
Reporting Groups
| Description | |
|---|---|
| Stratum 1: Everolimus 10 mg | Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
Measured Values
| Stratum 1: Everolimus 10 mg | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
115 |
|
Time to Overall Survival (OS)(Stratum 1)
[units: months] Median ( 95% Confidence Interval ) |
28.78
( 20.24 to 36.37 ) |
No statistical analysis provided for Time to Overall Survival (OS)(Stratum 1)
| 10. Secondary: | Time to Overall Survival (OS) (Stratum 2) [ Time Frame: from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Time to Overall Survival (OS) (Stratum 2) |
| Measure Description |
Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed. |
| Time Frame | from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The full analysis set consisted of all patients who received at least one dose of everolimus. |
Reporting Groups
| Description | |
|---|---|
| Stratum 2: Everolimus 10 mg + Octreotide Depot |
Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
Measured Values
| Stratum 2: Everolimus 10 mg + Octreotide Depot | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
45 |
|
Time to Overall Survival (OS) (Stratum 2)
[units: months] Median ( 95% Confidence Interval ) |
38.77
( 29.08 to NA ) [1] |
| [1] | The upper limit was not estimable in the study as it is longer than duration of study. |
|---|
No statistical analysis provided for Time to Overall Survival (OS) (Stratum 2)
| 11. Secondary: | Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2) [ Time Frame: Cycle 1 Day 15 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2) |
| Measure Description | For all patients in both strata, a blood sample for everolimus trough level determination will be collected immediately prior to the everolimus administration on Cycle 1 Day 15, Cycle 2 Day 1, and every month thereafter. A treatment cycle was defined as 28 days of consecutive daily treatment with everolimus and treatment continued until tumor progression. It is critical that patients not take their daily everolimus dose before the sample is drawn. |
| Time Frame | Cycle 1 Day 15 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with everolimus pharmacokinteic samples, with nonzero concentration, at Cycle 1 Day 15 were included |
Reporting Groups
| Description | |
|---|---|
| Stratum 1: Everolimus 10 mg | Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
| Stratum 2: Everolimus 10 mg + Octreotide Depot |
Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
Measured Values
| Stratum 1: Everolimus 10 mg | Stratum 2: Everolimus 10 mg + Octreotide Depot | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
92 | 30 |
|
Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2)
[units: ng/ml] Mean ± Standard Deviation |
15.7 ± 15.82 | 17.3 ± 18.08 |
No statistical analysis provided for Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2)
| 12. Secondary: | Effect of Octreotide Depot on the Trough Concentrations of Everolimus [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Effect of Octreotide Depot on the Trough Concentrations of Everolimus |
| Measure Description | The effect of Octreotide Depot on the trough concentrations of everolimus was assessed at Cycle 1 Day 15. |
| Time Frame | Cycle 1 Day 1, Cycle 2 Day 1 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with Octreotide Depot pharmacokinetic samples, with nonzero concentration, at Cycle 1 Day 1 or Cycle 2 Day 1 were included. |
Reporting Groups
| Description | |
|---|---|
| Stratum 2: Everolimus 10 mg + Octreotide Depot |
Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
Measured Values
| Stratum 2: Everolimus 10 mg + Octreotide Depot | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
38 |
|
Effect of Octreotide Depot on the Trough Concentrations of Everolimus
[units: ng/ml] Mean ± Standard Deviation |
|
| Cycle 1 Day 1 (pre-treatment baseline) (n=37) | 3.2 ± 2.81 |
| Cycle 2 Day 1 (n= 38) | 3.7 ± 3.47 |
No statistical analysis provided for Effect of Octreotide Depot on the Trough Concentrations of Everolimus
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Novartis Study Director
Organization: Novartis Pharmaceuticals
phone: (862 778-8300
Organization: Novartis Pharmaceuticals
phone: (862 778-8300
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00363051 History of Changes |
| Other Study ID Numbers: | CRAD001C2239 |
| Study First Received: | August 2, 2006 |
| Results First Received: | December 2, 2011 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |