Clinical trial · Interventional
Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma
A Phase 1/2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of Lenalidomide in Combination With Sunitinib in Subjects With Advanced or Metastatic Renal Cell Carcinoma
NCT00975806CI-TRIAL-00041889terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): MTD determined sub-optimal as efficacious treatment for renal cell carcinoma.
Summary
Brief summary (as posted)
The purpose of this study was to determine the maximum tolerated dose, safety, and effectiveness of lenalidomide (CC-5013) administered in combination with sunitinib as treatment for patients with renal cell carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- Participants received an oral dose of lenalidomide MTD (mg) capsule administered in combination with a single dose of sunitinib 37.5 mg on days 1-21 of each 21-day cycle
- interventionNames
- Drug: Lenalidomide
- Drug: Sunitinib
- type
- EXPERIMENTAL
- label
- Cohorts F and G
- description
- Participants received an oral daily dose of lenalidomide on Days 1 to 21 in combination with a single oral daily dose of sunitinib 37.5 mg on days 1 to 14 or days 1 to 21 of each 21-day cycle
- interventionNames
- Drug: Lenalidomide
- Drug: Sunitinib
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Metastatic Renal Cell Carcinoma. 2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Exclusion Criteria: 1. Prior chemotherapy. 2. Prior treatment with lenalidomide, thalidomide, pomalidomide, or sunitinib. 3. Laboratory values outside normal ranges. 4. Myocardial infarction (MI) within past 12 months. 5. Current congestive heart failure.
References
Publications (1)
- RESULTRini B, Redman B, Garcia JA, Burris HA 3rd, Li S, Fandi A, Beck R, Jungnelius U, Infante JR. A phase I/II study of lenalidomide in combination with sunitinib in patients with advanced or metastatic renal cell carcinoma. Ann Oncol. 2014 Sep;25(9):1794-1799. doi: 10.1093/annonc/mdu212. Epub 2014 Jun 8. PMID 24914044