Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.
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ClinicalTrials.gov Identifier: NCT01024920 |
Recruitment Status :
Completed
First Posted : December 3, 2009
Results First Posted : June 17, 2020
Last Update Posted : July 14, 2020
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Condition or disease | Intervention/treatment | Phase |
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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 |
Actual Primary Completion Date : | November 8, 2011 |
Actual Study Completion Date : | June 19, 2020 |

Arm | Intervention/treatment |
---|---|
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 |
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 |
- Probability Rates of Progression-free Survival at 9 Months [ Time Frame: Progression-free survival after 9 months ]
Progression free survival (PFS) at 9 months, calculated as the time (months) from randomisation to the occurrence of disease progression (by RECIST Version 1.1) or death, whichever occurred first.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Progression Free Survival (PFS) [ Time Frame: From the start of study until the cut-off date for 3 year efficacy analysis ]
Progression free survival (PFS) from randomisation to the occurrence of disease progression (by RECIST Version 1.1) or death, whichever occurred first.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Objective Response According to RECIST Criteria [ Time Frame: From the start of study until the cut-off date for 3 year efficacy analysis ]
Objective response was defined as complete response (CR) or partial response (PR) as determined by RECIST Version 1.1.
Per RECIST version 1.1. for target lesions and assessed by Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Duration of Objective Response [ Time Frame: From the start of study until the cut-off date for 3 year efficacy analysis ]
Duration (months) of objective response was measured from the time of first objective response to the time of disease progression (by RECIST Version 1.1) or death, whichever occurred first.
Per RECIST version 1.1. for target lesions and assessed by Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
For those patients with an objective response, time to response was summarised by the planned imaging time points. A descriptive summary of the duration of response was also produced using Kaplan-Meier estimates.
- Overall Survival [ Time Frame: From the start of study until the cut-off date for 3 year efficacy analysis ]Overall survival was calculated as the time (months) from randomisation to death. Overall survival was analysed using the same methodology as for PFS. Patients for whom there was no evidence of death at the time of analysis were censored on the date that they were last known to have been alive.
- Time to Progression [ Time Frame: From the start of study until the cut-off date for 3 year efficacy analysis ]
Time to progression is defined as the time period from randomisation to objective tumour progression. Time to progression was analysed using the same methodology as for PFS. Patients with no progression (by RECIST Version 1.1) were censored at the date of the last evaluable imaging.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Time to Treatment Failure [ Time Frame: From the start of study until the cut-off date for 3 year efficacy analysis ]Time to treatment failure was defined as the time from randomisation to objective tumour progression (by RECIST Version 1.1), death, global deterioration of health status requiring treatment discontinuation, or start of new anticancer treatment, whichever came first.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 | |
Munic.Instit."City Clin.Hosp.#4" of Dnipro City Council | |
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 |
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 |
Other Study ID Numbers: |
1199.26 2009-009516-44 ( EudraCT Number ) |
First Posted: | December 3, 2009 Key Record Dates |
Results First Posted: | June 17, 2020 |
Last Update Posted: | July 14, 2020 |
Last Verified: | June 2020 |
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 Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |