Trial · NCT01218555
Study of Everolimus (RAD001) in Combination With Lenalidomide
NCT01218555, Phase 1, Completed, Emory University; results first posted 2022-01-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Everolimus (RAD001) in Combination With Lenalidomide. Trials, record NCT01218555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01218555
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Everolimus (RAD001) in Combination With Lenalidomide
- NCT number
- NCT01218555
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 44 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Solid Organ Malignancies, Adenoidcystic Carcinoma, Neuroendocrine Tumors
- Interventions
- Lenalidomide, Everolimus
- First posted
- 2010-10-11
- Last updated
- 2022-01-27
- Results first posted
- 2022-01-27
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level | Within the first 28 days for DLT and throughout the duration of the study for safety. | A standard 3 + 3 design was employed to study escalating doses of daily, orally administered lenalidomide and everolimus. Dose escalation to the next cohort required 0 of 3 or ≤1 of 6 patients with dose-limiting toxicity (DLT). Five dose cohorts were planned starting at dose level one with lenalidomide 10 mg and everolimus 5mg in a 28-day cycle up to maximum doses of 25 and 10 mg, respectively. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level | Within the first 28 days for DLT and throughout the duration of the study for safety. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level | Lenalidomide Combination With Everolimus | Lenalidomide/everolimus (10/5 mg) | 3 | Participants | |
| Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level | Lenalidomide Combination With Everolimus | Lenalidomide/everolimus(15/5 mg) | 3 | Participants | |
| Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level | Lenalidomide Combination With Everolimus | Lenalidomide/everolimus(20/5 mg) | 5 | Participants | |
| Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level | Lenalidomide Combination With Everolimus | Lenalidomide/everolimus(25/5 mg) | 3 | Participants | |
| Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level | Lenalidomide Combination With Everolimus | Lenalidomide/everolimus(25/10 mg) | 8 | Participants | |
| Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level | Lenalidomide Combination With Everolimus | Recommended Phase 2Dose: L (25mg) and E (10mg) | 22 | Participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 1 Lenalidomide/Everolimus 10/5 mg | 3 | |
| Overall Study | STARTED | Dose Level 2 Lenalidomide/Everolimus | 3 | |
| Overall Study | STARTED | Dose Level 3: Lenalidomide/Everolimus | 5 | |
| Overall Study | STARTED | Dose Level 4: Lenalidomide/Everolimus 20/5/mg | 3 | |
| Overall Study | STARTED | Dose Level 5: Lenalidomide/Everolimus (25/10mg) | 8 | |
| Overall Study | STARTED | RP2D: L (25mg) and E (10mg) | 22 | |
| Overall Study | COMPLETED | Dose Level 1 Lenalidomide/Everolimus 10/5 mg | 3 | |
| Overall Study | COMPLETED | Dose Level 2 Lenalidomide/Everolimus | 3 | |
| Overall Study | COMPLETED | Dose Level 3: Lenalidomide/Everolimus | 5 | |
| Overall Study | COMPLETED | Dose Level 4: Lenalidomide/Everolimus 20/5/mg | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events8
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 | Anorexia | Gastrointestinal disorders | Lenalidomide Combination With Everolimus | 11 | 44 | |
| other | Diarrhea | Gastrointestinal disorders | Lenalidomide Combination With Everolimus | 13 | 44 | |
| other | Nausea | Gastrointestinal disorders | Lenalidomide Combination With Everolimus | 11 | 44 | |
| other | ALT | Metabolism and nutrition disorders | Lenalidomide Combination With Everolimus | 7 | 44 | |
| other | Fatigue | General disorders | Lenalidomide Combination With Everolimus | 15 | 44 | |
| other | Rash | Skin and subcutaneous tissue disorders | Lenalidomide Combination With Everolimus | 9 | 44 | |
| other | Elevated AST | Metabolism and nutrition disorders | Lenalidomide Combination With Everolimus | 5 | 44 | |
| serious | All-Cause Mortality | General disorders | Lenalidomide Combination With Everolimus | 18 | 44 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenalidomide Combination With Everolimus | 18 | 44 |
| Total, other adverse events | Lenalidomide Combination With Everolimus | 38 | 44 |
| Total, serious adverse events | Lenalidomide Combination With Everolimus | 18 | 44 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32704173 | DERIVED |
Source PubMed
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/NCT01218555
GET https://conductscience.org/api/trials/v1/NCT01218555/registered