| General information |
| Database: | DB00145 |
| Objective: | Thisphase I, openlabel doseescalation study investigated BIBF 1120 combined with paclitaxel (Taxol) and carboplatin in firstline patients with advanced (IIIB/IV) non small cell lung cancer. |
| Authors: | Doebele RC, et al |
| Title: | a phase I, openlabel doseescalation study of continuous treatment with BIBF 1120 in combination with paclitaxel and carboplatin as firstline treatment in patients with advanced non small cell lung cancer. |
| Journal: | Ann Oncol. |
| Year: | 2012 |
| PMID: | 22345119 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | BIBF 1120
|
| Target: | VEGFR 13, FGFR 13, PDFGR ¦Á and ¦Â
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | BIBF 1120 + paclitaxel + carboplatin |
| Study Type: | a phase I, openlabel doseescalation study |
| Key Patients Feature: | Adult patients with pathologically confirmed stage IIIB (including malignant pleural effusion) or stage IV non small cell lung cancer of all histologies |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | NA |
| Treatment Info: | Patients received BIBF 1120 (starting dose 50 mg b.i.d.) on days 221 and paclitaxel (200 mg/m2) and carboplatin [area under curve (AUC)=6 mg/ml/min] on day 1 of each 21day cycle. Primary end points were safety and BIBF 1120 maximum tolerated dose (MTD) in this combination. Pharmacokinetics (PK) profiles were evaluated. |
| Primary End Point: | MDT, DLT, PK, PD, PR, SD, and Aes |
| Secondary End Point: | NA |
| Patients Number: | 26 |
| Trial Results |
| DLT_MTD: | MTD was 200 mg b.i.d. in combination with paclitaxel and carboplatin. Six doselimiting toxicity events occurred during treatment cycle 1 (liver enzyme elevations, thrombocytopenia, abdominal pain, and rash). |
| Objective Response Rate: | NA |
| Disease Control Rate: | Best responses included 7 confirmed partial responses (26.9%); 10 patients had stable disease. BIBF 1120 200 mg b.i.d. had no clinically relevant influence on the PK of paclitaxel 200 mg/m2 and carboplatin AUC 6 mg/ml/min and vice versa. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | (liver enzyme elevations, thrombocytopenia, abdominal pain, and rash). |
| Conclusions: | BIBF 1120 MTD was 200 mg b.i.d when given with paclitaxel and carboplatin; this combination demonstrated an acceptable safety profile. No relevant changes in PK parameters of the backbone chemotherapeutic agents or BIBF 1120 they were observed. |