Trial · NCT00767819
Treatment of Patients With RAD001 With Progressive Sarcoma
NCT00767819, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2019-04-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Patients With RAD001 With Progressive Sarcoma. Trials, record NCT00767819. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00767819
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Patients With RAD001 With Progressive Sarcoma
- NCT number
- NCT00767819
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 71 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Progressive Sarcoma
- Interventions
- Everolimus
- First posted
- 2008-10-07
- Last updated
- 2019-04-01
- Other registries' IDs
- eudract:2007-005294-60
- Results first posted
- 2019-04-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response Rates by Week 16 (ITT) | Baseline up to 16 weeks | The best overall response is the best response recorded from treatment start until disease progression/recurrence (both measurement and confirmation criteria). Best lesion response was defined by (Resist Criteria V1 for target and non-target lesions): Complete Response (CR)=at least two determinations of CR 4 weeks apart before progression, Partial Response (PR)=at least two determinations of CR 4 weeks apart before progression (and not qualifying for a CR), Stable Disease (SD)=at least one SD assessment \>6 weeks after start of treatment and Progressive Disease (PD)=Progression or death due to underlying cancer ≤16 weeks after start of treatment. PD without radiologic evidence were classified as progression only, when clear evidence of clinical deterioration was available and patient discontinued due to "disease progression". Unknown (UNK) = all other cases. |
| Secondary | Objective Tumor Response Rates (Complete Response and Partial Response) at Week 16 (ITT) | Baseline up to approximately 16 weeks | The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Best lesion response was defined by (Resist Criteria V1 for target and non-target lesions). |
| Secondary | Percentage of Participants With Duration of Response (CR, PR, SD) at 16 Weeks. | Baseline up to 16 weeks | Duration of response (CR, PR or SD) applied only to those patients whose best overall response was CR, PR or SD based on local radiologic assessments and was defined as the time from start of treatment to progression or death from underlying disease. Patients not experiencing progression or death at 16 weeks were censored with the date of their last tumor assessment. Duration of response was explored using the Kaplan-Meier method. |
| Secondary | Percentage of Participants With Progression-free Survival (PFS) at 16 Weeks | 16 weeks | Progression-free Survival (PFS) was defined as the time from the date of start of treatment to the date of event defined as the first documented progression or death from any cause. If a patient had not had an event, PFS was censored at the date of the last adequate tumor assessment at week 16 |
| Secondary | Time to Progression (TTP) (ITT) | Baseline up to 16 weeks | Time to progression (TTP) was defined as the time from the date of start of treatment to the date of event defined as the first documented progression or death from underlying disease. If a patient had not had an event, TTP was censored at the date of the last adequate tumor assessment, which was the date of Visit 6 (Week 16) for the core phase and the last available tumor assessment for the follow-up phase. TTP was explored by using the Kaplan-Meier method. |
| Secondary | Percentage of Participants With Overall Survival (OS) at Week 16 (ITT) | Baseline up to 16 weeks | Overall survival (OS) was defined as the time from the date of start of treatment to death from any cause. If a patient was not known to have died (was alive), OS was censored at the date of the last contact, which was the date of Visit 6 (Week 16) for the core phase and the last available visit for the follow-up phase. OS was explored by using the Kaplan-Meier method. One death occurred in Arm 3 after Week 16. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response Rates by Week 16 (ITT) | Baseline up to 16 weeks | percentage of participants | NUMBER | |
| SECONDARY | Objective Tumor Response Rates (Complete Response and Partial Response) at Week 16 (ITT) | Baseline up to approximately 16 weeks | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Duration of Response (CR, PR, SD) at 16 Weeks. | Baseline up to 16 weeks | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Progression-free Survival (PFS) at 16 Weeks | 16 weeks | percentage of participants | NUMBER | |
| SECONDARY | Time to Progression (TTP) (ITT) | Baseline up to 16 weeks | days | MEDIAN | |
| SECONDARY | Percentage of Participants With Overall Survival (OS) at Week 16 (ITT) | Baseline up to 16 weeks | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response Rates by Week 16 (ITT) | Arm 1 | Complete Response | 0 | percentage of participants | |
| Best Overall Response Rates by Week 16 (ITT) | Arm 2 | Complete Response | 0 | percentage of participants | |
| Best Overall Response Rates by Week 16 (ITT) | Arm 3 | Complete Response | 0 | percentage of participants | |
| Best Overall Response Rates by Week 16 (ITT) | Arm 1 | Partial Response | 0 | percentage of participants | |
| Best Overall Response Rates by Week 16 (ITT) | Arm 2 | Partial Response | 0 | percentage of participants | |
| Best Overall Response Rates by Week 16 (ITT) | Arm 3 | Partial Response | 0 | percentage of participants | |
| Best Overall Response Rates by Week 16 (ITT) | Arm 1 | Stable Disease | 40.5 | percentage of participants | |
| Best Overall Response Rates by Week 16 (ITT) | Arm 2 | Stable Disease | 33.3 | percentage of participants | |
| Best Overall Response Rates by Week 16 (ITT) | Arm 3 | Stable Disease | 100.0 | percentage of participants | |
| Best Overall Response Rates by Week 16 (ITT) | Arm 1 | Progressive Disease | 51.4 | percentage of participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 | 37 | |
| Overall Study | STARTED | Arm 2 | 24 | |
| Overall Study | STARTED | Arm 3 | 10 | |
| Overall Study | Intent to Treat (ITT) Analysis Set | Arm 1 | 37 | |
| Overall Study | Intent to Treat (ITT) Analysis Set | Arm 2 | 24 | |
| Overall Study | Intent to Treat (ITT) Analysis Set | Arm 3 | 10 | |
| Overall Study | Safety Analysis Set (SAF) | Arm 1 | 37 | |
| Overall Study | Safety Analysis Set (SAF) | Arm 2 | 24 | |
| Overall Study | Safety Analysis Set (SAF) | Arm 3 | 10 | |
| Overall Study | COMPLETED | Arm 1 | 12 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events540
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Arm I | 8 | 37 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Arm II | 9 | 24 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Arm III | 3 | 10 | |
| other | ANAEMIA OF MALIGNANT DISEASE | Blood and lymphatic system disorders | Arm I | 1 | 37 | |
| other | ANAEMIA OF MALIGNANT DISEASE | Blood and lymphatic system disorders | Arm II | 2 | 24 | |
| other | ANAEMIA OF MALIGNANT DISEASE | Blood and lymphatic system disorders | Arm III | 0 | 10 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Arm I | 3 | 37 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Arm II | 1 | 24 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Arm III | 1 | 10 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Arm I | 1 | 37 |
1 to 10 of 540Source ClinicalTrials.gov
See all 540 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I | 8 | 37 |
| Total, all-cause mortality | Arm II | 4 | 24 |
| Total, all-cause mortality | Arm III | 1 | 10 |
| Total, other adverse events | Arm I | 35 | 37 |
| Total, other adverse events | Arm II | 21 | 24 |
| Total, other adverse events | Arm III | 10 | 10 |
| Total, serious adverse events | Arm I | 15 | 37 |
| Total, serious adverse events | Arm II | 14 | 24 |
| Total, serious adverse events | Arm III | 8 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00767819
GET https://conductscience.org/api/trials/v1/NCT00767819/results?page=2