Clinical trial · Interventional
Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.
A Randomised, Open Label, Parallel Group Phase II Study Comparing the Efficacy and Tolerability of BIBF 1120 Versus Sunitinib in Previously Untreated Patients With Renal Cell Cancer
NCT01024920CI-TRIAL-00052756completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Compare safety and efficacy of BIBF 1120 versus sunitinib in patients with advanced RCC and to investigate the effects of BIBF 1120 on the heart rate (HR) corrected QT interval (QTcF).
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 |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIBF 1120 | Drug | Nintedanib | ALIAS |
| sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nintedanib (BIBF 1120)
- description
- Non-marketed substance: Twice daily oral doses of 200mg BIBF 1120 given continuously.
- interventionNames
- Drug: BIBF 1120
- type
- ACTIVE_COMPARATOR
- label
- sunitinib
- description
- Marketed substance: Once a day oral doses of 50mg sunitinib given in repeated 6 week cycles: 4 weeks active, 2 weeks rest.
- interventionNames
- Drug: sunitinib
Primary outcomes (2)
- measure
- Probability Rates of Progression-free Survival at 9 Months
- timeFrame
- At 9 months after randomisation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Patients with unresectable or metastatic Renal Cell Cancer, who have received no previous systemic anti-cancer treatment. 2. Histological-confirmed diagnosis of renal cell cancer with clear cell component. 3. Acceptable renal,liver,cardiovascular,bone marrow and other functions to allow sunitinib/BIBF 1120 treatment. Exclusion criteria: 1. Patients unable to tolerate Sunitinib/BIBF 1120 treatment 2. Treatment with other investigational drugs or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study. 3. Patients unable to comply with the 1199.26 protocol. 4. Pregnancy or breast feeding. 5. Active alcohol or drug abuse. 6. Women of child bearing potential, or men who are able to father a child, unwilling to use a medically acceptable form of contraception during the study period.
References
Publications (2)
- DERIVEDAldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2. PMID 37146227
- DERIVEDEisen T, Shparyk Y, Macleod N, Jones R, Wallenstein G, Temple G, Khder Y, Dallinger C, Studeny M, Loembe AB, Bondarenko I. Effect of small angiokinase inhibitor nintedanib (BIBF 1120) on QT interval in patients with previously untreated, advanced renal cell cancer in an open-label, phase II study. Invest New Drugs. 2013 Oct;31(5):1283-93. doi: 10.1007/s10637-013-9962-7. Epub 2013 Apr 27. PMID 23625328