Trial record 1 of 7 for:
nintedanib renal
Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.
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| ClinicalTrials.gov Identifier: NCT01024920 |
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Recruitment Status :
Active, not recruiting
First Posted : December 3, 2009
Last Update Posted : December 4, 2018
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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Brief Summary:
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Carcinoma, Renal Cell | Drug: BIBF 1120 Drug: sunitinib | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 99 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | December 16, 2009 |
| Estimated Primary Completion Date : | February 15, 2019 |
| Estimated Study Completion Date : | February 15, 2019 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: BIBF 1120
Non-marketed substance: Twice daily oral doses of 200mg BIBF 1120 given continuously.
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Drug: BIBF 1120
VEGF inhibitor |
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Active Comparator: sunitinib
Marketed substance: Once a day oral doses of 50mg sunitinib given in repeated 6 week cycles: 4 weeks active, 2 weeks rest.
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Drug: sunitinib
VEGF inhibitor |
Primary Outcome Measures :
- Progression Free Survival at 9 months. [ Time Frame: 9 months of treatment ]
- For patients treated with with BIBF 1120. Change from baseline to endpoint (day 15) of the QT interval at each point in time QTcF (QT interval corrected by the Fridericia formula). [ Time Frame: 9 months of treatment ]
Secondary Outcome Measures :
- Progression Free survival [ Time Frame: 18 months ]
- Objective Response [ Time Frame: 36 months ]
- Duration of Response [ Time Frame: 36 months ]
- Overall Survival [ Time Frame: 36 months ]
- Time to treatment failure. [ Time Frame: 36 months ]
- Time to progression. [ Time Frame: 36 months ]
- BIBF 1120 patients only: - Change from baseline to Day 1 of QTcF interval at each point in time. - QTcF interval at the time of each patient's maximum BIBF 11230 concentration - Time-averaged QTcF interval over 1-12 hours. [ Time Frame: 15 Days ]
- Safety Endpoints all patients: Frequency of Adverse Events. -Number and duration of hospital stays due to Adverse Events -Dose-related dose reduction and discontinuation rate -Laboratory parameters graded by CTCAE v3 -PR and QRS intervals of ECG: [ Time Frame: 36 months ]
- BIBF 1120 patients only: - New onset of QT/QTc>500ms - New onset of QTc>470ms - New onset of QTc>450ms [ Time Frame: 15 days ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Patients with unresectable or metastatic Renal Cell Cancer, who have received no previous systemic anti-cancer treatment.
- Histological-confirmed diagnosis of renal cell cancer with clear cell component.
- Acceptable renal,liver,cardiovascular,bone marrow and other functions to allow sunitinib/BIBF 1120 treatment.
Exclusion criteria:
- Patients unable to tolerate Sunitinib/BIBF 1120 treatment
- 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.
- Patients unable to comply with the 1199.26 protocol.
- Pregnancy or breast feeding.
- Active alcohol or drug abuse.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024920
Locations
| Hungary | |
| University of Pecs Medical School, Dept. of Oncotherapy | |
| Pecs, Hungary, 7624 | |
| Poland | |
| Ziemia Lubelska Oncological Center, Lublin | |
| Lublin, Poland, 20-099 | |
| Onco.Cent. - Instit. of Maria Sklodowskiej-Curie | |
| Warszawa, Poland, 02-781 | |
| Romania | |
| Military Central Clinical Emergency Hospital | |
| Bucharest, Romania, 010825 | |
| Sf. Nectarie Oncology Center, Craiova | |
| Craiova, Romania, 200347 | |
| ONCOLAB SRL, Craiova | |
| Craiova, Romania, 200385 | |
| Ukraine | |
| Municipal Establishment Cherkasy Oncology Centre | |
| Cherkasy, Ukraine, 18009 | |
| Bukovynsk State Medical University | |
| Chernivtsi, Ukraine, 58013 | |
| City Clinical Hospital #4, Dnipropetrovsk State Medical Academy | |
| Dnipropetrovks, Ukraine, 49102 | |
| CI of LRC Lviv Onco.Reg.Treat.&Diag.Cent. | |
| Lviv, Ukraine, 79031 | |
| Uzhgorod National University, Oncology Centre | |
| Uzhgorod, Ukraine, 88000 | |
| United Kingdom | |
| Addenbrooke's Hospital | |
| Cambridge, United Kingdom, CB2 0QQ | |
| Beatson West of Scotland Cancer Centre | |
| Glasgow, United Kingdom, G12 0YN | |
| Surrey Cancer Research Institute | |
| Guildford, United Kingdom, GU2 7WG | |
| St James's University Hospital | |
| Leeds, United Kingdom, LS9 7TF | |
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01024920 History of Changes |
| Other Study ID Numbers: |
1199.26 2009-009516-44 ( EudraCT Number ) |
| First Posted: | December 3, 2009 Key Record Dates |
| Last Update Posted: | December 4, 2018 |
| Last Verified: | December 2018 |
Additional relevant MeSH terms:
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Carcinoma, Renal Cell Kidney Neoplasms Kidney Diseases Nintedanib Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Urologic Diseases Sunitinib Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |