Sarcoma, Soft TissuePhase 2NCT00859456
Sunitinib in Certain Subtypes of Soft Tissue Sarcomas
A Phase 2 study testing Sunitinib in people with Sarcoma, Soft Tissue, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to determine the clinical response rate (complete response and partial response) in patients with metastatic, locally advanced, or locally recurrent vascular soft tissue sarcoma treated with sunitinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Soft Tissue
- What is being tested?
- Sunitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Feb 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histopathologically-proven diagnosis of angiosarcoma, epithelioid sarcoma-like hemangioendothelioma or Kaposi's sarcoma. Both HIV-Related and HIV-Unrelated Kaposi's patients will be included in the trial. Patients with HIV-Related Kaposi's will be required to have a CD4 count >50 cells/µL and Viral Load < 50 copies/ml. They will also need to be willing to take HAART. They can either have stable Kaposi's on HAART for at least 3 months or have progression of their Kaposi's after having been on HAART for at least 10 weeks.
- Not amenable to surgery, radiation, or combined modality treatment with curative intent.
- Evidence of unidimensionally measurable disease by conventional radiographic techniques. In patients with Kaposi's sarcoma, skin lesions at least 10 mm will be considered measurable disease. Bone lesions, ascites, or lymphangitis of skin or lung are not considered measurable.
- No more than 2 prior chemotherapy regimens for metastatic or unresectable disease. Patients may have received prior bevacizumab or other Tyrosine Kinase Inhibitors, excluding sunitinib. Treatment with bevacizumab or other Tyrosine Kinase Inhibitors will not be counted as prior chemotherapy regimens.
- Four weeks since prior chemotherapy, surgery or radiation therapy and resolution of all toxic effects of any prior therapy, surgical procedure or radiation.
- ECOG performance status 0-2.
- Age 18 or greater.
Who cannot join
- Patients with a "currently active" second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered. Patients who are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
- No areas of measurable disease by CT or MRI.
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, or cerebrovascular accident. or transient ischemic attack, or pulmonary embolism.
- Ongoing cardiac dysrhythmias, atrial fibrillation or prolongation of the QTc interval to >450 msec for males of > 470 msec for females. Medications that may prolong the QT intervals should be discontinued or switched to another medication prior to starting Sutent unless determined by the investigator to be absolutely necessary.
- Pregnancy or breastfeeding.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with the study participation or study drug administration.
- Major surgery or radiation therapy within 4 weeks of starting the study treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: A Phase II, Open-label, Non-randomized Trial of Sunitinib in Certain Subtypes of Soft Tissue Sarcomas
The purpose of this study is to determine the clinical response rate (complete response and partial response) in patients with metastatic, locally advanced, or locally recurrent vascular soft tissue sarcoma treated with sunitinib.
Read the detailed description
Soft tissue sarcomas are rare tumors that arise from mesenchymal tissue from anywhere in the body. While surgical intervention can offer a cure for localized soft tissue sarcoma, treatment of unresectable and metastatic disease is particularly challenging. New treatment options are needed for patients with unresectable or metastatic disease if they progress or cannot tolerate conventional chemotherapy. This study will investigate sunitinib - a novel orally-administered multitargeted tyrosine kinase inhibitor with anti-tumor and antiangiogenic activities.
- Conditions
- Sarcoma, Soft Tissue
- Being tested
- Sunitinib
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Also called Sutent, Sunitinib malate, SU011248
Taken daily PO for a 42 day cycle. This cycle is repeated at least twice.
A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs).
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib | Experimental | Patients with unresectable or metastatic angiosarcoma, epithelioid sarcoma-like hemangioendothelioma and Kaposi's sarcoma, either receiving Sunitinib as first-line therapy or failure after no more than 2 prior chemotherapy regimens. Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Stable Disease at First Assessment of Response
CT or MRI to monitor response: CT or MRI to assess tumor measurement based on the RECIST criteria
Measured: Up to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startApr 2007
- Primary completionNov 2012
- Study completionFeb 2013
Why it stopped: Closed by pharmaceutical sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sarcoma, Soft TissueStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert N Taub, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859456
- Sponsor's protocol ID
- AAAC2308
- Status last verified
- Oct 2019
- First submitted
- 9 Mar 2009
- Last updated
- 4 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Non-randomized Trial of Sunitinib in Certain Subtypes of Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT00859456
- Acronym / sponsor ID
- AAAC2308
- Conditions
- Sarcoma, Soft Tissue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed by pharmaceutical sponsor
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Apr 2007 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the clinical response rate (complete response and partial response) in patients with metastatic, locally advanced, or locally recurrent vascular soft tissue sarcoma treated with sunitinib.
Detailed description
Soft tissue sarcomas are rare tumors that arise from mesenchymal tissue from anywhere in the body. While surgical intervention can offer a cure for localized soft tissue sarcoma, treatment of unresectable and metastatic disease is particularly challenging. New treatment options are needed for patients with unresectable or metastatic disease if they progress or cannot tolerate conventional chemotherapy. This study will investigate sunitinib - a novel orally-administered multitargeted tyrosine kinase inhibitor with anti-tumor and antiangiogenic activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunitinib | Experimental | Drug: SunitinibPatients with unresectable or metastatic angiosarcoma, epithelioid sarcoma-like hemangioendothelioma and Kaposi's sarcoma, either receiving Sunitinib as first-line therapy or failure after no more than 2 prior chemotherapy regimens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histopathologically-proven diagnosis of angiosarcoma, epithelioid sarcoma-like hemangioendothelioma or Kaposi's sarcoma. Both HIV-Related and HIV-Unrelated Kaposi's patients will be included in the trial. Patients with HIV-Related Kaposi's will be required to have a CD4 count >50 cells/µL and Viral Load < 50 copies/ml. They will also need to be willing to take HAART. They can either have stable Kaposi's on HAART for at least 3 months or have progression of their Kaposi's after having been on HAART for at least 10 weeks.
- Not amenable to surgery, radiation, or combined modality treatment with curative intent.
- Evidence of unidimensionally measurable disease by conventional radiographic techniques. In patients with Kaposi's sarcoma, skin lesions at least 10 mm will be considered measurable disease. Bone lesions, ascites, or lymphangitis of skin or lung are not considered measurable.
- No more than 2 prior chemotherapy regimens for metastatic or unresectable disease. Patients may have received prior bevacizumab or other Tyrosine Kinase Inhibitors, excluding sunitinib. Treatment with bevacizumab or other Tyrosine Kinase Inhibitors will not be counted as prior chemotherapy regimens.
- Four weeks since prior chemotherapy, surgery or radiation therapy and resolution of all toxic effects of any prior therapy, surgical procedure or radiation.
Key exclusion criteria (7 listed)
- Patients with a "currently active" second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered. Patients who are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
- No areas of measurable disease by CT or MRI.
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, or cerebrovascular accident. or transient ischemic attack, or pulmonary embolism.
- Ongoing cardiac dysrhythmias, atrial fibrillation or prolongation of the QTc interval to >450 msec for males of > 470 msec for females. Medications that may prolong the QT intervals should be discontinued or switched to another medication prior to starting Sutent unless determined by the investigator to be absolutely necessary.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| SunitinibAlso: Sutent, Sunitinib malate, SU011248Taken daily PO for a 42 day cycle. This cycle is repeated at least twice. A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs). | Drug | Sunitinib |
Primary outcome
Number of Subjects With Stable Disease at First Assessment of Response
Time frame: Up to 84 days
CT or MRI to monitor response: CT or MRI to assess tumor measurement based on the RECIST criteria
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Robert N Taub, MD, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib in people with Sarcoma, Soft Tissue, run by Columbia University at 1 site 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 7 inclusion and 7 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 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 4 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Stable Disease at First Assessment of Response (time frame: Up to 84 days). 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 4 Nov 2019.