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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Spectrum Pharmaceuticals, Inc
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01773785
First received: January 14, 2013
Last updated: June 10, 2014
Last verified: June 2014

January 14, 2013
June 10, 2014
April 2013
July 2015   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01773785 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer
Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line Treatment for Patients With Advanced Biliary Cancer

The primary purpose of this study is to determine the effectiveness of SPI-1620 in combination with docetaxel in patients with advanced biliary cancer.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Biliary Cancer
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.
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.
Intervention: Drug: SPI-1620 & Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
39
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Angie Schinkel 949-743-9257 angie.schinkel@sppirx.com
United States
 
NCT01773785
SPI-1620-12-202
No
Spectrum Pharmaceuticals, Inc
Spectrum Pharmaceuticals, Inc
Not Provided
Study Director: Mi Rim Choi, MD Spectrum Pharmaceuticals, Inc
Spectrum Pharmaceuticals, Inc
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP