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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
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BIBF 1120
Non-marketed substance: Twice daily oral doses of 200mg BIBF 1120 given continuously.
 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.
 Drug: sunitinib
VEGF inhibitor


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.

  5. 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.


  6. 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.


Eligibility Criteria
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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:

  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.
Contacts and Locations
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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
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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
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
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
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action