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Br J Cancer. 2017 Jul 11;117(2):189-194. doi: 10.1038/bjc.2017.160. Epub 2017 Jun 20.

Phase 2 study of combination SPI-1620 with docetaxel as second-line advanced biliary tract cancer treatment.

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Department of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center &Research Institute, 12902 Magnolia Drive FOB-2, Tampa, FL 33612, USA.
Division of Oncology, Department of Medicine, University of Washington, 825 Eastlake Avenue E, G4-833, Seattle, WA 98109-1023, USA.
Division of Medical Oncology, Department of Medicine, Washington University School of Medicine, 5225 Midamerica Plaza, St Louis, MO 63129, USA.
Department of Radiology, Washington University School of Medicine, 5225 Midamerica Plaza, St Louis, MO 63129, USA.
Department of Pathology, Washington University School of Medicine, 5225 Midamerica Plaza, St Louis, MO 63129, USA.
Associate Cancer Center Director for Translational Research, Gibbs Cancer Center &Research Institute, 380 Serpentine Drive, Suite 200, Spartanburg, SC 29303, USA.
Associates in Oncology &Hematology, 2205 McCallie Avenue, Suite 502, Chattanooga, TN 37404, USA.
Associate Director of Biostatistics, Spectrum Pharmaceuticals Inc., 157 Technology Drive, Irvine, CA 92618, USA.
West Cancer Center, 7945 Wolf River Boulevard, Memphis, TN 38138, USA.



This multicentre, open-label study evaluated the efficacy and safety of SPI-1620, an analogue of endothelin-1, administered in combination with docetaxel as second-line treatment for patients with advanced biliary tract cancer (ABTC).


Eligible patients received continuous cycles of combination therapy with SPI-1620 (11 μg m-2) and docetaxel (75 mg m-2) intravenously every 3 weeks until disease progression (PD) or intolerable toxicity. Tumour response was evaluated using computed tomography or magnetic resonance imaging every 2 cycles (6 weeks). The primary efficacy end point was progression-free survival (PFS); secondary end points included overall response rate (ORR), duration of response, and overall survival (OS) that were estimated using the Kaplan-Meier method.


Of the 30 enrolled patients, 25 patients had qualifying events (PD or death), 1 patient was nonevaluable, and 4 patients were censored at the time of their last tumour assessment. Our primary end point of PFS ⩾5 months was not reached. Median PFS was 2.6 months (95% confidence interval (CI): 1.4-2.8), ranging from 0.7 to 8.4 months. The ORR was 10.3% (95% CI: 0.02-0.27). Eleven additional patients achieved stable disease. The OS was 4.87 months. The most common grade 3-4 toxicities were febrile neutropenia and neutropenia.


The addition of docetaxel to SPI-1620 in second-line ABTC did not meet the pre-specified primary end point of PFS ⩾5 months in unselected patient population.

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