PMID- 24849708
OWN - NLM
STAT- MEDLINE
DCOM- 20150407
LR  - 20181202
IS  - 1473-5741 (Electronic)
IS  - 0959-4973 (Linking)
VI  - 25
IP  - 9
DP  - 2014 Oct
TI  - Randomized phase II study of nintedanib in metastatic castration-resistant 
      prostate cancer postdocetaxel.
PG  - 1081-8
LID - 10.1097/CAD.0000000000000131 [doi]
AB  - This open-label, phase II trial assessed the efficacy and safety of two doses of 
      nintedanib, a triple angiokinase inhibitor targeting vascular endothelial growth 
      factor, fibroblast growth factor, and platelet-derived growth factor signaling, 
      in patients with metastatic castration-resistant prostate cancer (mCRPC) 
      following progression on docetaxel-based regimens. Patients were randomized to 
      nintedanib 150 mg (arm A, n=40) or 250 mg (arm B, n=41) twice daily for 6 months 
      unless disease progression or adverse events (AEs) led to discontinuation. The 
      primary endpoint was the prostate-specific antigen (PSA) response rate (confirmed 
      PSA decline of >/=20% from baseline). Eighty-one patients were enrolled. The PSA 
      response rate was 0% (0/32) in arm A versus 11.1% (4/36) in arm B (P=0.12); 5.6% 
      of patients (2/36) in arm B showed a PSA reduction of at least 50%. In arm B, the 
      rate of PSA increase was significantly decelerated on treatment versus before 
      treatment (P=0.002). The median progression-free survival was 73.5 and 76.0 days 
      for arm A and arm B, respectively (P=0.3). AEs included gastrointestinal 
      disorders, asthenia, hypertension, and reversible elevated transaminases. The 
      incidence of drug-related serious AEs (no drug-related deaths) was 20.0% (arm A) 
      and 24.4% (arm B). The primary endpoint was not met. Nintedanib (250 mg) showed 
      only modest activity with manageable AEs in patients with mCRPC post-docetaxel.
FAU - Droz, Jean-Pierre
AU  - Droz JP
AD  - aDepartment of Medical Oncology, Centre Leon-Berard, Claude Bernard Lyon-1 
      University, Lyon bMedical Oncology Department, Georges Pompidou European Hospital 
      (HEGP), Paris cDepartment of Medical Oncology, Institut Claudius Regaud, Toulouse 
      dBoehringer Ingelheim France S.A.S, Reims, France eBoehringer Ingelheim Pharma 
      GmbH & Co. KG, Biberach, Germany.
FAU - Medioni, Jaques
AU  - Medioni J
FAU - Chevreau, Christine
AU  - Chevreau C
FAU - De Mont-Serrat, Helene
AU  - De Mont-Serrat H
FAU - Merger, Michael
AU  - Merger M
FAU - Stopfer, Peter
AU  - Stopfer P
FAU - Kaiser, Rolf
AU  - Kaiser R
FAU - Oudard, Stephane
AU  - Oudard S
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Anticancer Drugs
JT  - Anti-cancer drugs
JID - 9100823
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Indoles)
RN  - 0 (Taxoids)
RN  - 0 (Tubulin Modulators)
RN  - 15H5577CQD (Docetaxel)
RN  - G6HRD2P839 (nintedanib)
SB  - IM
MH  - Adenocarcinoma/*drug therapy/secondary
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/adverse effects/pharmacokinetics/*therapeutic use
MH  - Disease Progression
MH  - Disease-Free Survival
MH  - Docetaxel
MH  - Humans
MH  - Indoles/adverse effects/pharmacokinetics/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Prostatic Neoplasms, Castration-Resistant/*drug therapy/pathology
MH  - Taxoids/therapeutic use
MH  - Tubulin Modulators/therapeutic use
EDAT- 2014/05/23 06:00
MHDA- 2015/04/08 06:00
CRDT- 2014/05/23 06:00
PHST- 2014/05/23 06:00 [entrez]
PHST- 2014/05/23 06:00 [pubmed]
PHST- 2015/04/08 06:00 [medline]
AID - 10.1097/CAD.0000000000000131 [doi]
PST - ppublish
SO  - Anticancer Drugs. 2014 Oct;25(9):1081-8. doi: 10.1097/CAD.0000000000000131.