West Cancer Center

BILIARY TRACT; Metastatic; 2nd Line; "SPI-1620-12-202"

Phase II study of SPI-1620 in combination with docetaxel as a second-line treatment for patients with advanced biliary cancer

Title

Spectrum SPI-1620-12-202

Study Title

Phase II study of SPI-1620 in combination with docetaxel as a second-line treatment for patients with advanced biliary cancer

Site Link

NCT01773785

Malignancy

Bile Duct, Gallbladder, Biliary Tract

Stage

Stage 4

Disease Setting

Line Of Therapy

2nd

Investigational Agent

SPI-1620

Drug Class

Endothelin B (ETB) agonist

David Portnoy, MD

Sponsor

Spectrum Pharmaceuticals

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01773785?term=SPI-1620-12-202&rank=1

Key Eligibility Criteria Details

Histologically confirmed biliary tract or gallbladder cancer
Failure of one prior gemcitabine-based chemo regimen
ECOG PS 0-2
No uncontrolled CNS mets
No significant circulatory disorders in last 6 months
No conmed of phosphodiesterase inhibitor
No high-grade baseline peripheral neuropathy

Objective

Primary- PFS: Secondary- ORR, OS, DoR, Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Dosing Frequency

SPI-1620 11mcg/m2 and Docetaxel 75mg/m2 IV q3weeks

Control Agents

N/A

Study Protocol

Randomized