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

October 8, 2021 updated by: Spectrum Pharmaceuticals, Inc

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Hospitals & Clinics/ Sylvester Comprehensive Cancer Center
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington University School of Medicine
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Associates in Oncology and Hematology
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 18 months
18 months
Duration of Response
Time Frame: 12 months
12 months
Overall response rate
Time Frame: 18 months
18 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Pharmaceuticals, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 14, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (Estimate)

January 23, 2013

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

October 8, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPI-1620-12-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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