| General information |
| Database: | DB00883 |
| Objective: | BIBF 1120 is an oral, potent, tyrosine kinase inhibitor that simultaneously targets vascular endothelial growth factor receptors 13, plateletderived growth factor receptors ¦Á and ¦Â, and fibroblast growth factor receptors 13, as well as FLT3 and Src. Currently, the molecule is inphase III development for secondline non small cell lung cancer and firstline ovarian cancer patients. |
| Authors: | Bousquet G, et al |
| Title: | Phase I study of BIBF 1120 with docetaxel and prednisone in metastatic chemonaive hormonerefractory prostate cancer patients. |
| Journal: | Br J Cancer. |
| Year: | 2011 |
| PMID: | 22027711 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | BIBF 1120
|
| Target: | VEGFR 13, FGFR 13, PDFGR ¦Á and ¦Â
|
| Cancer Type: | prostate cancer |
| Cancer Subtype: | advanced castrationresistant prostate cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | BIBF 1120 with docetaxel + prednisone |
| Study Type: | Phase I study |
| Key Patients Feature: | patients with metastatic, chemonaive, hormonerefractory prostate cancer (HRPC). |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | BIBF 1120: 100 mg versus 150 mg versus 200 mg versus 250 mg |
| Treatment Info: | continuous daily treatment with BIBF 1120 plus standarddose docetaxel (75 mg m(2), every 3 weeks) and prednisone (5 mg BID) |
| Primary End Point: | safety and maximum tolerated dose; |
| Secondary End Point: | characterisation of BIBF 1120 and docetaxel pharmacokinetics (PK), and preliminary antitumour activity |
| Patients Number: | 12 |
| Trial Results |
| DLT_MTD: | Alternatively, the occurrence of uncomplicated grade 4 neutropenia for >7 days, neutropenia grade 3 associated with fever 38.5 ¡ãC, or grade 4 thrombopenia or grade 3 thrombopenia associated with bleeding in any cycle beyond TC 1, was defined as a DLT. he maximum tolerated dose (MTD) was defined as the dose at which less than two out of six patients experienced a DLT in TC 1. |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | progression free survival rate at 24 weeks was 56% |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | During TC 1, the most frequent drugrelated AEs were diarrhoea (71.4%), asthenia (61.9%), nausea (28.6%), vomiting (28.6%), and alopecia (23.8%). Overall, the severity of AEs during TC 1 was grade 1 in six patients (28.6%), grade 2 in six patients (28.6%), grade 3 in five patients (23.8%), and grade 4 in three patients (14.3%). |
| Conclusions: | Based on the overall safety profile, 200?mg BID was the recommended dose for the combination of BIBF 1120 with the standard dose of 75?mg?m(2) of docetaxel and prednisone that might be further investigated in HRPC patients. This combination was well tolerated, with preliminary signs of efficacy and no indication of PK interaction bettheyen BIBF 1120 and docetaxel. |