Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer

This study has been terminated.
(The study completed the first phase and did not meet efficacy end point to enter into the randomized phase.)
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc Identifier:
First received: January 14, 2013
Last updated: July 20, 2016
Last verified: July 2016
The primary purpose of this study is to determine the effectiveness of SPI-1620 in combination with docetaxel in patients with advanced biliary cancer.

Condition Intervention Phase
Biliary Cancer
Drug: SPI-1620 & Docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line Treatment for Patients With Advanced Biliary Cancer

Resource links provided by NLM:

Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety of SPI-1620 when administered in combination with docetaxel [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed

Enrollment: 30
Study Start Date: April 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPI-1620 & Docetaxel
  • SPI-1620 11 μg/m2 will be given intravenously over 1 minute.
  • Docetaxel 75 mg/m2 infusion will be administered per standard of care 10 (±2) minutes after SPI-1620.
Drug: SPI-1620 & Docetaxel
Patients will receive 11 μg/m2 of SPI-1620 intravenously over one minute. Ten minutes after (±2 min) SPI-1620 administration, patients will receive docetaxel 75 mg/m2 intravenous. This regimen will be repeated every 3-weeks cycles until progression or intolerable toxicity.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed biliary tract or gallbladder cancer that have relapsed or are refractory after one prior gemcitabine-based chemotherapy regimen for advanced biliary cancer
  • Evaluable disease
  • ECOG PS ≤ 2
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Treatment with more than one prior chemotherapy regimen
  • Known, uncontrolled CNS metastases
  • Baseline peripheral neuropathy ≥ grade 2.
  • Significant circulatory disorders in the past 6 months
  • Concomitant use of phosphodiesterase inhibitors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01773785

United States, Florida
University of Miami Hospitals & Clinics/ Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States
United States, Tennessee
Associates in Oncology and Hematology
Chattanooga, Tennessee, United States, 37421
The West Clinic
Memphis, Tennessee, United States, 38120
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Study Director: Mi Rim Choi, MD Spectrum Pharmaceuticals, Inc
  More Information

Responsible Party: Spectrum Pharmaceuticals, Inc Identifier: NCT01773785     History of Changes
Other Study ID Numbers: SPI-1620-12-202 
Study First Received: January 14, 2013
Last Updated: July 20, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016