PMID- 20054647
OWN - NLM
STAT- MEDLINE
DCOM- 20100323
LR  - 20211203
IS  - 1573-7217 (Electronic)
IS  - 0167-6806 (Linking)
VI  - 120
IP  - 1
DP  - 2010 Feb
TI  - A phase 1B dose escalation trial of Scutellaria barbata (BZL101) for patients 
      with metastatic breast cancer.
PG  - 111-8
LID - 10.1007/s10549-009-0678-5 [doi]
AB  - The purpose of this study was to determine the safety and maximum tolerated dose 
      (MTD) of BZL101 (FDA IND# 59,521), an orally delivered aqueous extract from the 
      herb Scutellaria barbata, in women with metastatic breast cancer (MBC). The trial 
      was an open-label, phase 1B, multicenter, dose escalation study. Eligible 
      patients had histologically confirmed breast cancer and measurable stage IV 
      disease. The standard phase 1 "3 + 3" study design was used to determine the MTD. 
      Primary endpoints were toxicity and MTD of BZL101. Secondary outcomes included 
      efficacy based on RECIST criteria. A total of 27 women with a median of 2 prior 
      chemotherapy treatments for metastatic disease were treated in four different 
      dose cohorts. Grade 3 and 4 adverse events (AEs) were uncommon. Dose-limiting 
      toxicities included the following: grade 4 AST elevation, grade 3 diarrhea, grade 
      3 fatigue, and grade 3 rib pain. Fourteen patients were evaluable according to 
      Response Evaluation Criteria in Solid Tumors. Investigator assessment classified 
      three patients with stable disease for >120 days (21%). One patient was on BZL101 
      for 449 days and remains stable for 700 + days. Independent radiology review 
      identified three patients with objective tumor regression (>0% and <30%). The MTD 
      was not reached, thus per protocol, the MTD was defined as the maximum 
      administered dose of BZL101 40 g/day. In conclusion, oral administration of 
      BZL101 was safe, well tolerated, and showed promising clinical evidence of 
      anticancer activity in this heavily pretreated population of women with MBC.
FAU - Perez, Alejandra T
AU  - Perez AT
AD  - Memorial Cancer Institute, Hollywood, FL, USA.
FAU - Arun, Banu
AU  - Arun B
FAU - Tripathy, Debu
AU  - Tripathy D
FAU - Tagliaferri, Mary A
AU  - Tagliaferri MA
FAU - Shaw, Heather S
AU  - Shaw HS
FAU - Kimmick, Gretchen G
AU  - Kimmick GG
FAU - Cohen, Isaac
AU  - Cohen I
FAU - Shtivelman, Emma
AU  - Shtivelman E
FAU - Caygill, Katherine A
AU  - Caygill KA
FAU - Grady, Deborah
AU  - Grady D
FAU - Schactman, Mark
AU  - Schactman M
FAU - Shapiro, Charles L
AU  - Shapiro CL
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - Netherlands
TA  - Breast Cancer Res Treat
JT  - Breast cancer research and treatment
JID - 8111104
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Plant Extracts)
RN  - 0 (Scutellaria barbata extract)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/*administration & dosage/adverse effects
MH  - Breast Neoplasms/*drug therapy/pathology
MH  - Female
MH  - Humans
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Phytotherapy/*methods
MH  - Plant Extracts/*administration & dosage/adverse effects
MH  - Scutellaria
EDAT- 2010/01/08 06:00
MHDA- 2010/03/24 06:00
CRDT- 2010/01/08 06:00
PHST- 2009/12/02 00:00 [received]
PHST- 2009/12/04 00:00 [accepted]
PHST- 2010/01/08 06:00 [entrez]
PHST- 2010/01/08 06:00 [pubmed]
PHST- 2010/03/24 06:00 [medline]
AID - 10.1007/s10549-009-0678-5 [doi]
PST - ppublish
SO  - Breast Cancer Res Treat. 2010 Feb;120(1):111-8. doi: 10.1007/s10549-009-0678-5.