Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.

NCT01024920 | Completed Phase 2 Results

• 2 other identifiers: 1199.262009-009516-44
• Study Type: interventional
• Target: 99
• Locations: 5 countries
• Sites: 15

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).

Conditions

Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (2)

• Probability Rates of Progression-free Survival at 9 Months

  Progression free survival rate at 9 months is the estimated probability of being alive and not having progressive disease at 9 months after randomisation. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria version 1.1 (RECIST v1.1), at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started together with an absolute increase in the sum of the longest diameters of at least 5 mm, or the appearance of one or more new lesions. Tumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication.

  At 9 months after randomisation.

• Time-matched Change From Baseline to Day 15 in QTcF (QT Interval Corrected by the Fridericia Formula) at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120)

  QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate by the Fridericia formula. Baseline QTcF measurement at time t was defined as the QTcF measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 15 in QTcF at time t was defined as the QTcF measurement following administration of nintedanib on Day 15 obtained at time t minus baseline QTcF measurement at time t. 0 h is 5 min prior to dosing on Day 15. Time-matched change from baseline to Day 15 in QTcF was modelled using a linear mixed-effects model for repeated measures which included 'time' as repeated measures and the time-matched baseline value as a covariate. Adjusted means with corresponding 2-sided 90% confidence intervals at 0 h,1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h and 12 h after dosing of nintedanib on Day 15 of are reported.

  At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 15. Baseline (Day -1) values were taken at exactly the same time points as on Day 15.

Secondary Outcomes (41)

• Progression Free Survival (PFS)

  From the start of study until the cut-off date for 3 year efficacy analysis, up to 3 years.

• Objective Response According to RECIST Criteria

  From the start of study until the cut-off date for 3 year efficacy analysis, up to 3 years.

• Duration of Objective Response

  From the time of first objective response to the time of disease progression or death (whichever comes first), up to 3 years.

• Overall Survival

  From randomisation to death, up to 3 years.

• Time to Progression

  From randomisation up to objective tumour progression, up to 3 years.

Study Arms (2)

Nintedanib (BIBF 1120)

EXPERIMENTAL

Non-marketed substance: Twice daily oral doses of 200mg BIBF 1120 given continuously.

Drug: BIBF 1120

sunitinib

ACTIVE COMPARATOR

Marketed substance: Once a day oral doses of 50mg sunitinib given in repeated 6 week cycles: 4 weeks active, 2 weeks rest.

Drug: sunitinib

Interventions

BIBF 1120 DRUG

VEGF inhibitor

Nintedanib (BIBF 1120)

sunitinib DRUG

VEGF inhibitor

sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (15)

University of Pecs Medical School, Dept. of Oncotherapy

Pécs, 7624, Hungary

Location

Ziemia Lubelska Oncological Center, Lublin

Lublin, 20-099, Poland

Location

Onco.Cent. - Instit. of Maria Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

Military Central Clinical Emergency Hospital

Bucharest, 010825, Romania

Location

Sf. Nectarie Oncology Center, Craiova

Craiova, 200347, Romania

Location

ONCOLAB SRL, Craiova

Craiova, 200385, Romania

Location

Municipal Establishment Cherkasy Oncology Centre

Cherkasy, 18009, Ukraine

Location

Bukovynsk State Medical University

Chernivtsi, 58013, Ukraine

Location

Munic.Instit."City Clin.Hosp.#4" of Dnipro City Council

Dnipropetrovks, 49102, Ukraine

Location

CI of LRC Lviv Onco.Reg.Treat.&Diag.Cent.

Lviv, 79031, Ukraine

Location

Uzhgorod National University, Oncology Centre

Uzhhorod, 88000, Ukraine

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Surrey Cancer Research Institute

Guildford, GU2 7WG, United Kingdom

Location

St James's University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Related Publications (2)

• Aldin 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 DERIVED

• Eisen 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 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

nintedanib; Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: December 3, 2009
• Study Start: December 16, 2009
• Primary Completion: November 8, 2011
• Study Completion: June 19, 2020
• Last Updated: July 19, 2021
• Results First Posted: June 17, 2020

Record last verified: 2021-06

Locations

HU (1); RO (3); GB (4); UA (5); PL (2)