Phase 2
Completed N=128
BIBF 1120 Versus Bevacizumab in Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT00904839 ↗Enrolled (actual)
128
Serious AEs
42.1%
Results posted
Feb 2015
Primary outcomePrimary: Progression-free Survival Rate at 9 Months (PFS-9) — 62.1; 70.2 percentage of Participants
Summary
The primary objective of this study is to evaluate PFS rate at 9 months of BIBF 1120 in combination with mFolfox6 compared with mFolfox6 combined to bevacizumab in first line patients with metastatic colorectal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival Rate at 9 Months (PFS-9) |
62.1; 70.2 | — |
| SECONDARY Overall Survival |
27.8; 33.4 | — |
| SECONDARY Progression-free Survival (PFS) |
10.5; 15.4 | — |
| SECONDARY Confirmed Objective Response Rate |
63.5; 56.1 | — |
| SECONDARY Unconfirmed Objective Response Rate |
69.4; 73.2 | — |
| SECONDARY Resection Rate |
19.5; 24.5 | — |
| SECONDARY Tumor Shrinkage |
58; 29; 19; 7; 4; 4 | — |
| SECONDARY Incidence and Intensity of Adverse Events With Grading According CTCAE |
1; 0; 9; 2; 62; 29 | — |
| SECONDARY Percentage of Patients With Dose Limit Toxicity (DLTs) Incidence During the First Two Treatment Cycles (Phase I). |
0.0; 11.1; 0.0; 11.1; 33.3; 0.0 | — |
| SECONDARY Maximum Tolerable Dose (MTD) |
200; 200 | — |
| SECONDARY Area Under the Plasma Concentration Time-curve Over 12 Hours for Nintedanib in the Dosing Interval at Steady State and Normalized by the Dosing Unit Administered (AUCtau,ss,Norm) (Phase I) |
1.46; 1.53 | — |
| SECONDARY Maximum Plasma Concentration for Nintedanib at Steady State and Normalized by the Dosing Unit Administered (Cmax,ss,Norm) (Phase I) |
0.294; 0.278 | — |
| SECONDARY Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-C30 for the Change From Baseline at 9 Months of Global Health Status Scores. |
-1.7; -9.8 | — |
| SECONDARY Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the Change From Baseline at 9 Months. |
-3.2; -3.5; 22.7; 6.1; -33.3; -11.1 | — |
| SECONDARY Number of Participants for Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the First Use of Stoma Bag. |
10; 4; 3; 0; 1; 0 | — |
| SECONDARY Exploratory Biomarker and Pharmacogenetic Analysis for VEGF |
— | — |
Eligibility Criteria
Inclusion criteria
- Age >= 18 years
- Histologically proven colorectal adenocarcinoma
- No previous oxaliplatin based chemotherapy is allowed unless disease free survival after the end of chemotherapy > = 12 months
- No previous therapy with VEGFR or EGFR inhibitors
- No prior systemic therapy for metastatic CRC
- No previous adjuvant therapy with fluoropyrimidines is allowed unless disease free survival after the end of chemotherapy > 6 months
- ECOG performance status < = 2
- Adequate hepatic, renal and bone marrow functions:
- No uncontrolled hypertension
- Signed and dated written informed consent prior to admission to the study
Exclusion criteria
- Treatment with any investigational drug within 28 days of trial onset.
- History of other malignancies in the last 5 years, in particular those that could affect compliance with the protocol or interpretation of results.
- Serious concomitant disease, especially those affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug,
- Major injuries and/or surgery or bone fracture within 4 weeks of trial inclusion, or planned surgical procedures during the trial period.
- Significant cardiovascular diseases
- History of severe haemorrhagic or thromboembolic event in the past 12 months. Known inherited predisposition to bleeding or to thrombosis.
- Patient with brain metastases that are symptomatic and/or require therapy.
- Pregnancy or breast-feeding.
Data sourced from ClinicalTrials.gov (NCT00904839). 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.