Biliary CancerPhase 2NCT01773785
Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer
A Phase 2 study testing SPI-1620 and Docetaxel in people with Biliary Cancer, run by Spectrum Pharmaceuticals, Inc at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Cancer
- What is being tested?
- SPI-1620 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2013to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Associates in Oncology and Hematology
Chattanooga, Tennessee, 37421
The West Clinic
Memphis, Tennessee, 38120
University of Miami Hospitals & Clinics/ Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: 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.
- Conditions
- Biliary Cancer
- Being tested
- SPI-1620, Docetaxel
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPI-1620Drug
SPI-1620 11 μg/m2 will be given intravenously over 1 minute.
DocetaxelDrug
Docetaxel 75 mg/m2 infusion will be administered per standard of care 10 (±2) minutes after SPI-1620.
| Study group | Role | What they receive |
|---|---|---|
| SPI-1620 & Docetaxel | Experimental | 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. Receives: Drug: SPI-1620; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 18 months
Secondary outcomes (4)
Overall response rate
Measured: 18 months
Overall survival
Measured: 18 months
Duration of Response
Measured: 12 months
Safety of SPI-1620 when administered in combination with docetaxel
Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: The study completed the first phase and did not meet efficacy end point to enter into the randomized phase.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773785
- Sponsor's protocol ID
- SPI-1620-12-202
- Status last verified
- Oct 2021
- First submitted
- 14 Jan 2013
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line Treatment for Patients With Advanced Biliary Cancer
- ClinicalTrials.gov ID
- NCT01773785
- Acronym / sponsor ID
- SPI-1620-12-202
- Conditions
- Biliary Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study completed the first phase and did not meet efficacy end point to enter into the randomized phase.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2013 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPI-1620 & Docetaxel | Experimental | Drug: SPI-1620, Drug: DocetaxelPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPI-1620SPI-1620 11 μg/m2 will be given intravenously over 1 minute. | Drug | SPI-1620 & Docetaxel |
| DocetaxelDocetaxel 75 mg/m2 infusion will be administered per standard of care 10 (±2) minutes after SPI-1620. | Drug | SPI-1620 & Docetaxel |
Primary outcome
Progression free survival
Time frame: 18 months
4 secondary outcomes
Overall response rate
Time frame: 18 months
Overall survival
Time frame: 18 months
Duration of Response
Time frame: 12 months
Safety of SPI-1620 when administered in combination with docetaxel
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The study completed the first phase and did not meet efficacy end point to enter into the randomized phase.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
Related trials for Biliary Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPI-1620 and Docetaxel in people with Biliary Cancer, run by Spectrum Pharmaceuticals, Inc at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study completed the first phase and did not meet efficacy end point to enter into the randomized phase.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.