Document Detail

A phase I, open-label dose-escalation study of continuous treatment with BIBF 1120 in combination with paclitaxel and carboplatin as first-line treatment in patients with advanced non-small-cell lung cancer.
MedLine Citation:
PMID:  22345119     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: BIBF 1120 is an oral potent inhibitor of vascular endothelial growth factor receptor, fibroblast growth factor receptor and platelet-derived growth factor receptor, the three key receptor families involved in angiogenesis. This phase I, open-label dose-escalation study investigated BIBF 1120 combined with paclitaxel (Taxol) and carboplatin in first-line patients with advanced (IIIB/IV) non-small-cell lung cancer.
PATIENTS AND METHODS: Patients received BIBF 1120 (starting dose 50 mg b.i.d.) on days 2-21 and paclitaxel (200 mg/m2) and carboplatin [area under curve (AUC)=6 mg/ml/min] on day 1 of each 21-day cycle. Primary end points were safety and BIBF 1120 maximum tolerated dose (MTD) in this combination. Pharmacokinetics (PK) profiles were evaluated.
RESULTS: Twenty-six patients were treated (BIBF 1120 50-250 mg b.i.d.). BIBF 1120 MTD was 200 mg b.i.d. in combination with paclitaxel and carboplatin. Six dose-limiting toxicity events occurred during treatment cycle 1 (liver enzyme elevations, thrombocytopenia, abdominal pain, and rash). 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.
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 were observed.
R C Doebele; P Conkling; A M Traynor; G A Otterson; Y Zhao; S Wind; P Stopfer; R Kaiser; D R Camidge
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2012-02-16
Journal Detail:
Title:  Annals of oncology : official journal of the European Society for Medical Oncology / ESMO     Volume:  23     ISSN:  1569-8041     ISO Abbreviation:  Ann. Oncol.     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-07-26     Completed Date:  2012-11-19     Revised Date:  2014-08-27    
Medline Journal Info:
Nlm Unique ID:  9007735     Medline TA:  Ann Oncol     Country:  England    
Other Details:
Languages:  eng     Pagination:  2094-102     Citation Subset:  IM    
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MeSH Terms
Antineoplastic Combined Chemotherapy Protocols / administration & dosage*,  adverse effects*,  pharmacokinetics
Carboplatin / administration & dosage,  adverse effects,  blood
Carcinoma, Non-Small-Cell Lung / blood,  drug therapy*,  pathology
Cohort Studies
Dose-Response Relationship, Drug
Drug Administration Schedule
Indoles / administration & dosage,  adverse effects,  blood
Lung Neoplasms / blood,  drug therapy*,  pathology
Middle Aged
Neoplasm Staging
Paclitaxel / administration & dosage,  adverse effects,  blood
Grant Support
Reg. No./Substance:
0/Indoles; 33069-62-4/Paclitaxel; BG3F62OND5/Carboplatin; G6HRD2P839/nintedanib

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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