Phase 2
Completed N=99
Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.
Carcinoma, Renal Cell
Source: ClinicalTrials.gov NCT01024920 ↗
Enrolled (actual)
99
Serious AEs
32.3%
Results posted
Jun 2020
Primary outcomePrimary: Probability Rates of Progression-free Survival at 9 Months — 0.431; 0.452 Probability — p=0.8531
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Probability Rates of Progression-free Survival at 9 Months |
0.431; 0.452 | 0.8531 |
| PRIMARY 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) |
2.6; 0.4; -1.7; -0.5; -0.5; 0.3 | — |
| SECONDARY Progression Free Survival (PFS) |
8.44; 8.38 | 0.6395 |
| SECONDARY Objective Response According to RECIST Criteria |
0; 1; 14; 11 | 0.1213 |
| SECONDARY Duration of Objective Response |
19.42; 11.66 | — |
| SECONDARY Overall Survival |
20.37; 21.22 | 0.7593 |
| SECONDARY Time to Progression |
8.48; 8.54 | 0.5958 |
| SECONDARY Time to Treatment Failure |
8.44; 8.36 | 0.5712 |
| SECONDARY Time-matched Change From Baseline to Day 1 in QTcF (QT Interval Corrected by the Fridericia Formula) 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 Dosing of Nintedanib (BIBF 1120) |
-1.6; -3.1; -2.6; -2.6; -1.4; -2.0 | — |
| SECONDARY Time-matched Change From Baseline in QTcF Interval (QT Interval Corrected by the Fridericia Formula) at the Time of Each Participant's Maximum Plasma Concentration of Nintedanib (BIBF 1120), Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
-2.8; -3.2 | — |
| SECONDARY Time-Matched Change From Baseline in QTcF Interval at the Time of Each Patient's Maximum Plasma Concentration of BIBF 1202 (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
-2.5; -1.1 | — |
| SECONDARY Time-Matched Change From Baseline in QTcF Interval at the Time of Each Patient's Maximum Plasma Concentration of BIBF 1202-glucuronide (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
-2.4; -1.5 | — |
| SECONDARY Average Time-matched Changes From Baseline in QTcF Interval Over 1 h to 12 h After Dosing on Days 1 and 15 of Treatment Cycle 1 |
-2.2; 0.5 | — |
| SECONDARY Time-matched Changes From Baseline to Day 15 in QT Interval 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) |
1.0; 0.5; 1.6; 4.4; 4.7; 5.1 | — |
| SECONDARY Time-matched Changes From Baseline to Day 1 in QT Interval 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 Dosing of Nintedanib (BIBF 1120) |
-2.0; 1.6; 3.5; 1.4; 1.4; 1.8 | — |
| SECONDARY Time-Matched Change From Baseline in QT Interval at the Time of Each Patient's Maximum Plasma Concentration of Nintedanib (BIBF 1120), Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
0.9; -0.4 | — |
| SECONDARY Time-Matched Change From Baseline in QT Interval at the Time of Each Patient's Maximum Plasma Concentration of BIBF 1202 (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
1.2; 1.8 | — |
| SECONDARY Time-Matched Change From Baseline in QT Interval at the Time of Each Patient's Maximum Plasma Concentration BIBF 1202-glucuronide (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
-0.4; 1.3 | — |
| SECONDARY Averaged Time-matched Changes From Baseline in QT Interval (Electrocardiogram (ECG) Interval From the Beginning of the QRS Complex to the End of the T Wave) Over 1 h to 12 h After Dosing on Days 1 and 15 of Treatment Cycle 1 |
0.9; 4.2 | — |
| SECONDARY Time-Matched Heart Rate (HR) Changes From Baseline to Day 15 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) |
0.9; -0.3; -2.0; -3.3; -3.4; -3.1 | — |
| SECONDARY Time-Matched Heart Rate (HR) Changes From Baseline to Day 1 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 Dosing of Nintedanib (BIBF 1120) |
-0.0; -2.9; -3.8; -2.5; -1.8; -2.2 | — |
| SECONDARY Time-Matched Change From Baseline in Heart Rate (HR) at the Time of Each Patient's Maximum Nintedanib (BIBF 1120) Plasma Concentration, Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
-2.0; -2.1 | — |
| SECONDARY Time-Matched Change From Baseline in Heart Rate (HR) at the Time of Each Patient's Maximum Plasma Concentration of BIBF 1202 (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
-2.3; -2.0 | — |
| SECONDARY Time-Matched Change From Baseline in Heart Rate (HR) at the Time of Each Patient's Maximum Plasma Concentration of BIBF 1202-glucuronide (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
-1.2; -1.6 | — |
| SECONDARY Averaged Time-Matched Heart Rate (HR) Change From Baseline Over 1 to 12 Hours, Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
-1.9; -2.5 | — |
| SECONDARY Frequency of Patients With Maximum Time-Matched QTcF Interval Change From Baseline Categorized by Magnitude of Change, Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
64; 0; 0; 57; 6; 0 | — |
| SECONDARY Frequency of Patients With Maximum Time-Matched QT Interval (Electrocardiogram (ECG) Interval From the Beginning of the QRS Complex to the End of the T Wave) Change From Baseline Categorized by Magnitude of Change, Days 1 and 15 |
64; 0; 62; 1 | — |
| SECONDARY Number of Participants With New (Not Present at Any Time Pre-dose) Onset of QTcF ≤450 Milliseconds (ms), Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
3; 2 | — |
| SECONDARY Number of Participants With New (Not Present at Any Time Pre-dose) Onset of QTcF >450 to 470 Milliseconds (ms), Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
1; 1 | — |
| SECONDARY Number of Participants With New Onset of QTcF> 470 to 500 Milliseconds (ms), Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
0; 1 | — |
| SECONDARY Number of Participants With New (Not Present at Any Time Pre-dose) Onset of QTcF> 500 Milliseconds (ms) (Notable Prolongation), Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
0; 0 | — |
| SECONDARY Number of Participants With New (Not Present at Any Time Pre-dose) Onset of QT (Electrocardiogram (ECG) Interval From the Beginning of the QRS Complex to the End of the T Wave) > 500 ms (Notable Prolongation), Days 1 and 15 of Treatment Cycle 1 |
0; 0 | — |
| SECONDARY Absolute Values at Baseline (Day -1) and Day 1 and Changes From Baseline to Day 1 at Each Point in Time in PR Interval |
164.7; 165.7; 166.8; 166.6; 168.1; 167.2 | — |
| SECONDARY Absolute Values at Baseline (Day -1) and Day 15 and Changes From Baseline to Day 15 at Each Point in Time in PR Interval |
164.7; 165.7; 166.8; 166.5; 168.0; 167.2 | — |
| SECONDARY Absolute Values at Baseline (Day -1) and Day 1 and Changes From Baseline to Day 1 at Each Point in Time in QRS Interval |
92.4; 93.7; 93.2; 93.6; 92.7; 92.6 | — |
| SECONDARY Absolute Values at Baseline (Day -1) and Day 15 and Changes From Baseline to Day 15 at Each Point in Time in QRS Interval |
92.5; 93.8; 93.3; 93.6; 92.7; 92.7 | — |
| SECONDARY Frequency of Patients by Clinical Electrocardiogram (ECG) Measurement Interpretation, Calculated Separately for Days 1 and 15 of Treatment Cycle 1 |
39; 24; 1; 37; 25; 1 | — |
| SECONDARY Frequency of Adverse Events Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0 |
11; 5; 16; 6; 14; 16 | — |
| SECONDARY Number of Participants With Adverse Events Leading to Dose Reduction |
16; 8 | — |
| SECONDARY Number of Participants With Adverse Events Leading to Discontinuation of Trial Drug |
11; 5 | — |
| SECONDARY Number of Participants With Adverse Events Requiring or Prolonging Hospitalisation |
15; 10 | — |
| SECONDARY Duration of Hospital Stays Due to Adverse Events Requiring or Prolonging Hospitalisation |
11.40; 13.10 | — |
| SECONDARY Frequency of Patients With Possible Clinically Significant Abnormal Lab Values |
2; 3; 7; 0; 4; 5 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01024920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.