We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01773785
Recruitment Status : Terminated (The study completed the first phase and did not meet efficacy end point to enter into the randomized phase.)
First Posted : January 23, 2013
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Biliary Cancer Drug: SPI-1620 Drug: Docetaxel Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : April 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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.
 Drug: SPI-1620
SPI-1620 11 μg/m2 will be given intravenously over 1 minute.

Drug: Docetaxel
Docetaxel 75 mg/m2 infusion will be administered per standard of care 10 (±2) minutes after SPI-1620.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: 18 months ]
  2. Overall survival [ Time Frame: 18 months ]
  3. Duration of Response [ Time Frame: 12 months ]
  4. Safety of SPI-1620 when administered in combination with docetaxel [ Time Frame: 12 months ]
    Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773785


Locations
Layout table for location information
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
Saint 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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01773785    
Other Study ID Numbers: SPI-1620-12-202
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
 Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action