Trial · NCT00126672
RAPAMYCIN FOR KIDNEY ANGIOMYOLIPOMAS
NCT00126672, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2022-04-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RAPAMYCIN FOR KIDNEY ANGIOMYOLIPOMAS. Trials, record NCT00126672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00126672
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RAPAMYCIN FOR KIDNEY ANGIOMYOLIPOMAS
- NCT number
- NCT00126672
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Nonmalignant Neoplasm, Tuberous Sclerosis, Lymphangioleimyomatosis, Kidney Angiomyolipoma
- Interventions
- Rapamycin
- First posted
- 2005-08-04
- Last updated
- 2022-04-25
- Results first posted
- 2022-04-25
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | On treatment, patients were evaluated radiologically for response to therapy up to 52 weeks. | The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Secondary | Number of Participants With Grade 3 or More Treatment-Related Lymphopenia | Assessed on treatment up to 52 weeks. | All participants reporting maximum grade 3 or more lymphopenia adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv3 on case report forms were counted. |
| Secondary | Number of Participants With no Change Are Observed Changes That Occur in Other TSC Lesions | Data collected at week 52 | TSC lesions are tubers, subependymal giant cell astrocytomas, facial angiofibromas, kidney cysts. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate | On treatment, patients were evaluated radiologically for response to therapy up to 52 weeks. | percentage of participants | NUMBER | |
| SECONDARY | Number of Participants With Grade 3 or More Treatment-Related Lymphopenia | Assessed on treatment up to 52 weeks. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With no Change Are Observed Changes That Occur in Other TSC Lesions | Data collected at week 52 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate | Ramaycin | 44.4 | 95% Confidence Interval 28 to 61 | percentage of participants | |
| Number of Participants With Grade 3 or More Treatment-Related Lymphopenia | Ramaycin | 1 | Participants | ||
| Number of Participants With no Change Are Observed Changes That Occur in Other TSC Lesions | Ramaycin | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rapamycin | 36 | |
| Overall Study | COMPLETED | Rapamycin | 28 | |
| Overall Study | NOT COMPLETED | Rapamycin | 8 |
Source ClinicalTrials.gov
Adverse events94
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 | Anemia | Blood and lymphatic system disorders | Ramaycin | 2 | 36 | |
| other | Sinus tachycardia | Cardiac disorders | Ramaycin | 1 | 36 | |
| other | Endocrine disorders - Other, specify | Endocrine disorders | Ramaycin | 1 | 36 | |
| other | Abdominal pain | Gastrointestinal disorders | Ramaycin | 4 | 36 | |
| other | Constipation | Gastrointestinal disorders | Ramaycin | 4 | 36 | |
| other | Diarrhea | Gastrointestinal disorders | Ramaycin | 10 | 36 | |
| other | Dry mouth | Gastrointestinal disorders | Ramaycin | 4 | 36 | |
| other | Dyspepsia | Gastrointestinal disorders | Ramaycin | 2 | 36 | |
| other | Enterocolitis | Gastrointestinal disorders | Ramaycin | 1 | 36 | |
| other | Flatulence | Gastrointestinal disorders | Ramaycin | 1 | 36 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ramaycin | 0 | 36 |
| Total, other adverse events | Ramaycin | 36 | 36 |
| Total, serious adverse events | Ramaycin | 36 | 36 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA006516 | Dana-Farber/Harvard Cancer Center | EBERT, BENJAMIN LEVINE | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| R01CA107164 | Multicenter clinical trials for TSC & related disorders | DABORA, SANDRA L | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 2005 to 2008 | NIH RePORTER |
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/NCT00126672
GET https://conductscience.org/api/trials/v1/NCT00126672/events?page=2