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NCT01218555

Study of Everolimus (RAD001) in Combination With Lenalidomide

Completed Phase 1 Results posted Last updated 27 January 2022
What this trial tests

Phase 1 trial testing Lenalidomide in Solid Organ Malignancies in 44 participants. Completed in 5 November 2020.

Timeline
9 September 2010
Primary endpoint
5 November 2020
5 November 2020

Quick facts

Lead sponsorEmory University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment44
Start date9 September 2010
Primary completion5 November 2020
Estimated completion5 November 2020
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Emory University

Who can join

18 and older, any sex, with Solid Organ Malignancies or Adenoidcystic Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level Primary · 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.

GroupValue95% CI
Lenalidomide Combination With Everolimus3
Lenalidomide Combination With Everolimus3
Lenalidomide Combination With Everolimus5
Lenalidomide Combination With Everolimus3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events collected through study completion, an average of 1 year.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lenalidomide Combination With Everolimus
Serious: 18/44 (41%)
Deaths: 18/44

Serious adverse events (1 terms)

ReactionSystemLenalidomide Combination W…
All-Cause MortalityGeneral disorders
Other adverse events (7 terms — click to expand)

ReactionSystemLenalidomide Combination W…
FatigueGeneral disorders
DiarrheaGastrointestinal disorders
AnorexiaGastrointestinal disorders
NauseaGastrointestinal disorders
RashSkin and subcutaneous tissue disorders
ALTMetabolism and nutrition disorders
Elevated ASTMetabolism and nutrition disorders

Most-reported serious reactions: All-Cause Mortality.

Data from ClinicalTrials.gov NCT01218555 adverse events section.

Sponsor's own description

The purpose of this study is to study the combination of two anticancer drugs, everolimus (RAD001) and lenalidomide in patients whose cancer is no longer responding to standard treatment or patients who are unable to tolerate the standard treatment for their cancer.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A comprehensive overview of targeted therapy in metastatic renal cell carcinoma.
    Mihaly Z, Sztupinszki Z, Surowiak P, Gyorffy B. · · 2012 · cited 36× · PMID 22515521 · DOI 10.2174/156800912802429265
  2. Deep response to a combination of mTOR inhibitor temsirolimus and dual immunotherapy of nivolumab/ipilimumab in poorly differentiated thyroid carcinoma with <i>PTEN</i> mutation: a case report and literature review.
    Oh Y, Park JH, Djunadi TA, Shah Z, et al · · 2024 · cited 11× · PMID 38356955 · DOI 10.3389/fendo.2024.1304188
  3. Phase 1 safety and pharmacodynamic study of lenalidomide combined with everolimus in patients with advanced solid malignancies with efficacy signal in adenoid cystic carcinoma.
    Harvey RD, Carthon BC, Lewis C, Hossain MS, et al · · 2020 · cited 11× · PMID 32704173 · DOI 10.1038/s41416-020-0988-2
  4. Future directions of mammalian target of rapamycin (mTOR) inhibitor therapy in renal cell carcinoma.
    Pal SK, Figlin RA. · · 2011 · cited 10× · PMID 21484496 · DOI 10.1007/s11523-011-0172-y
  5. Race-, Age-, and Gender-Based Characteristics and Toxicities of Targeted Therapies on Phase I Trials.
    Owonikoko TK, Busari AK, Kim S, Chen Z, et al · · 2018 · cited 4× · PMID 29913438 · DOI 10.1159/000488763

Verify or expand the search:

Other trials of Lenalidomide

Trials testing the same drug.

Other recruiting trials for Solid Organ Malignancies

Currently open trials in the same condition.

Other Emory University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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