LiposarcomaPhase 2NCT00400569
Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
A Phase 2 study testing Sunitinib Malate (SU011248) in people with Liposarcoma and Leiomyosarcoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liposarcoma, Leiomyosarcoma, Fibrosarcoma
- What is being tested?
- Sunitinib Malate (SU011248)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Dec 2011
- 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
- Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade less than or equal to 1.
- Adequate organ function as defined by the following criteria:
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
- Total serum bilirubin less than or equal to 1.5 x ULN
- Absolute neutrophil count (ANC) greater than or equal to1500/microL
- Platelets greater than or equal to 100,000/microL
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- Hemoglobin greater than or equal to 9.0 g/dL
- Serum calcium less than or equal to 12.0 mg/dL
- Serum creatinine less than or equal to 1.5 x ULN
- Histologically-proven liposarcoma, leiomyosarcoma, fibrosarcoma, or MFH
- Measurable disease radiographically
- Disease that is deemed surgically unresectable and/or metastatic
- Age greater than or equal to 18 years
- Life expectancy greater than 16 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Patients may have had up to 3 prior chemotherapies within 4 weeks of starting the study treatment.
Who cannot join
- Major surgery or radiation therapy or chemotherapy within 4 weeks of starting the study treatment.
- NCI CTCAE version 3 grade 3 hemorrhage within 4 weeks of starting the study treatment.
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease.
- Any of the following within the 6 months prior to study drug administration:
- myocardial infarction,
- severe/unstable angina,
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- coronary/peripheral artery bypass graft,
- symptomatic congestive heart failure,
- cerebrovascular accident or transient ischemic attack, or pulmonary embolism
- Ongoing cardiac dysrhythmias of NCI CTCAE greater than or equal to grade 2
- Prolonged QTc interval on baseline electrocardiogram (ECG) > 500 msec.
- Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy)
- Prior tyrosine kinase inhibitor therapy
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
- Concurrent treatment on another clinical trial, except supportive care or non-treatment trials
- Concomitant use of agents known to induce or inhibit CYP3A4
- Concomitant use of agents metabolized by the cytochrome P450 system
- Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg by mouth [PO] daily for thrombo-prophylaxis is allowed)
- Pregnancy or breastfeeding patients
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: Phase II Open-Label Study of Sunitinib Malate (SU011248) in Adult Patients With Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity.
All patients with unresectable or metastatic soft tissue sarcoma (STS): leiomyosarcoma, liposarcoma, fibrosarcoma, and malignant fibrous histiocytoma (MFH) seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.
Read the detailed description
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate, an oral multi-kinase inhibitor. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity which in the opinion of the treating physician or the trial Principal Investigator (PI) compromises the ability of the patient to receive treatment or the patient desires to stop treatment.
All patients with unresectable or metastatic STS: leiomyosarcoma, liposarcoma, fibrosarcoma, and MFH seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.
An office visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination. Complete blood count (CBC) and differential, comprehensive metabolic panel, and electrocardiogram (ECG) will be obtained at every scheduled visit.
- Being tested
- Sunitinib Malate (SU011248)
- Keywords
- Sunitinib malate, SUTENT, SU011248, Soft tissue sarcoma, Gastrointestinal stromal tumors (GIST), MFH, Tyrosine kinase inhibitor, Imatinib mesylate, Phase II
- Medical subject headings
- Liposarcoma, Leiomyosarcoma, Fibrosarcoma, Histiocytoma, Malignant Fibrous, Sarcoma, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunitinib Malate (SU011248)Drug
Also called Sutent, SU011248
For each 6 week cycle, patients will take SU011248 every day in the morning for 4 weeks followed by a 2 week rest period.
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib Malate (SU011248) Treatment | Experimental | Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks Receives: Drug: Sunitinib Malate (SU011248) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Overall Response (OR)
Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: From On Treatment to Off Study - average of 6 months
Secondary outcomes (3)
Participants' Progression Free Survival (PFS)
Time to tumor progression defined as the duration of time from start of treatment to time of progression. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: From On Treatment to Off Study - average of 6 months
Participants' Overall Survival (OS)
The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.
Measured: From On Treatment to Off Study - average of 6 months
Number of Participants With Serious Adverse Events (SAEs)
Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.
Measured: 4 years, 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2011
- Study completionDec 2011
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 LiposarcomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Alberto Chiappori, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400569
- Sponsor's protocol ID
- MCC-14902
- Other IDs
- GA618075
- Status last verified
- Jul 2012
- First submitted
- 15 Nov 2006
- Last updated
- 28 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open-Label Study of Sunitinib Malate (SU011248) in Adult Patients With Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT00400569
- Acronym / sponsor ID
- MCC-14902
- Keywords
- Sunitinib malate, SUTENT, SU011248, Soft tissue sarcoma, Gastrointestinal stromal tumors (GIST), MFH, Tyrosine kinase inhibitor, Imatinib mesylate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Nov 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Nov 2006 (estimated)
- Results
- Posted 28 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity.
All patients with unresectable or metastatic soft tissue sarcoma (STS): leiomyosarcoma, liposarcoma, fibrosarcoma, and malignant fibrous histiocytoma (MFH) seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.
Detailed description
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate, an oral multi-kinase inhibitor. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity which in the opinion of the treating physician or the trial Principal Investigator (PI) compromises the ability of the patient to receive treatment or the patient desires to stop treatment.
All patients with unresectable or metastatic STS: leiomyosarcoma, liposarcoma, fibrosarcoma, and MFH seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.
An office visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination. Complete blood count (CBC) and differential, comprehensive metabolic panel, and electrocardiogram (ECG) will be obtained at every scheduled visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunitinib Malate (SU011248) Treatment | Experimental | Drug: Sunitinib Malate (SU011248)Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade less than or equal to 1.
- Adequate organ function as defined by the following criteria:
- Histologically-proven liposarcoma, leiomyosarcoma, fibrosarcoma, or MFH
- Measurable disease radiographically
- Disease that is deemed surgically unresectable and/or metastatic
Key exclusion criteria (21 listed)
- Major surgery or radiation therapy or chemotherapy within 4 weeks of starting the study treatment.
- NCI CTCAE version 3 grade 3 hemorrhage within 4 weeks of starting the study treatment.
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease.
- Any of the following within the 6 months prior to study drug administration:
- Ongoing cardiac dysrhythmias of NCI CTCAE greater than or equal to grade 2
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 |
|---|---|---|
| Sunitinib Malate (SU011248)Also: Sutent, SU011248For each 6 week cycle, patients will take SU011248 every day in the morning for 4 weeks followed by a 2 week rest period. | Drug | Sunitinib Malate (SU011248) Treatment |
Primary outcome
Number of Participants With Overall Response (OR)
Time frame: From On Treatment to Off Study - average of 6 months
Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).
3 secondary outcomes
Participants' Progression Free Survival (PFS)
Time frame: From On Treatment to Off Study - average of 6 months
Participants' Overall Survival (OS)
Time frame: From On Treatment to Off Study - average of 6 months
Number of Participants With Serious Adverse Events (SAEs)
Time frame: 4 years, 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Moffitt Cancer Center Clinical Trials WebsiteLink provided by the sponsor.
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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.
Alberto Chiappori, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
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 Malate (SU011248) in people with Liposarcoma and Leiomyosarcoma, run by H. Lee Moffitt Cancer Center and Research Institute 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 16 inclusion and 21 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: finished, as of the sponsor's last update on 28 Aug 2012. 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 28 Aug 2012). 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 Participants With Overall Response (OR) (time frame: From On Treatment to Off Study - average of 6 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 28 Aug 2012.