Genitourinary DiseasePhase 2NCT00912912
Sunitinib Malate in Refractory Germ Cell Tumors
A Phase 2 study testing Sunitinib Malate in people with Genitourinary Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if Sutent® (sunitinib malate, SU011248) can control the disease in patients with germ cell tumors that are resistant to earlier treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Genitourinary Disease
- What is being tested?
- Sunitinib Malate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 2014
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Progressive metastatic Germ-cell tumors (GCTs) of gonadal or extragonadal origin in males after failure of front-line therapy and at least one salvage regimen.
- Must have evaluable or measurable disease by clinical or radiological studies. Alternatively, in the absence of radiologically evaluable or measurable disease, two sequentially rising marker values each one week apart attributed by treating physician to germ cell tumor is permitted; either beta human chorionic gonadotropin (hCG) above 50 mIU/ml and/or alpha-fetoprotein (AFP) above 20 ng/ml qualifies as eligible.
- The Eastern Cooperative Oncology Group (ECOG) Performance Score 0-2
- Adequate organ function as follows: Calculated creatinine clearance >/= 35cc/min, Absolute neutrophil count >/= 1500/mm^3, hemoglobin >/= 8 g/dL, serum calcium </= 12 mg/dL, Platelet count >/= 75,000/mm^3, AST (SGOT)/ALT (SGPT) < 2.5 x upper limit of normal (ULN), Total bilirubin < 2.0mg/dl.
- Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade </= 2.
- At least 18 years of age as safety of sunitinib in a pediatric population has not been established.
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- Able to provide informed consent
- Must be able to ingest oral medication
- Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
- Patients who have not received prior high-dose chemotherapy and stem cell rescue as salvage therapy will have this option discussed with them. Only patients ineligible, unwilling or unable to undertake this option will be eligible for this trial.
Who cannot join
- NCI CTCAE Version 3.0 grade 3 hemorrhage within the 4 weeks prior to starting the study treatment.
- Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Patients with history of Long QT syndrome.
- Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade >/= 2.
- Uncontrolled Hypertension (> 140/90 mm Hg despite optimal medical therapy).
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
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- Symptomatic bowel obstruction.
- Prior VEGFR/PDGFR inhibitor therapy.
- Known human immunodeficiency virus infection, chronic active hepatitis or liver cirrhosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II Study of Sunitinib Malate in Refractory Germ Cell Tumors
The goal of this clinical research study is to learn if Sutent® (sunitinib malate, SU011248) can control the disease in patients with germ cell tumors that are resistant to earlier treatment.
Read the detailed description
The Study Drug:
Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.
Within 14 days of enrollment on this study, you will have the following tests and procedures performed:
- Your complete medical history will be recorded.
- You will have a physical exam.
Within 7 days of enrollment on this study, you will have the following tests and procedures performed:
-Blood (about 3 teaspoons) and urine will be collected for routine testing and to test for certain biomarkers (to check the status of the disease).
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take sunitinib malate capsules once a day (by mouth) for 4 weeks in a row followed by 2 weeks with no study drug. These 6 weeks are considered 1 cycle of study treatment.
Study Visits:
On Day 1 of each cycle (about every 6 weeks), you will have the following tests done before you take the study drug:
- You will have a physical exam.
- You will be asked about how you are feeling and about any side effects you have experienced since your last visit.
- You will have blood (about 3 teaspoons) and urine collected for routine tests and to test for certain biomarkers.
For the first 4 weeks of treatment, you should have your blood pressure monitored. This may be done at your home with a digital pressure device, or you may visit your local doctor for this testing.
About Day 21 of Cycles 1 and 2, blood (about 2- 3 teaspoons) will be drawn for routine tests. This may be done at your local doctor's office and results faxed to the study doctor.
On Day 1 of Cycle 2, Day 1 of Cycle 3, and then Day 1 of every 2 cycles after that (Cycle 5, Cycle 7, and so on), you will have imaging scans to check status of the disease. This could include CT or MRI scans, an ECG, and a chest x-ray. If your doctor thinks it is necessary, you may have additional imaging scans at any time.
On Day 1 of every other cycle (Cycle 3, Cycle 5, and so on), you will have an echocardiogram or MUGA scan.
Length of Study:
You may remain on study for as long as you are benefitting. You will be taken off study if intolerable side effects occur or if the disease gets worse. However, if the disease gets worse very quickly during Cycles 1 or 2, you will be taken off study at that time.
Off-Study Visit:
When you are taken off of treatment on this study, the following tests and procedures will be performed:
- You will have a physical exam.
- You will be asked how you are feeling and about any changes in your medical history since beginning this study.
- You will also be asked about any side effects you have experienced since your last visit.
This is an investigational study. Sunitinib malate is approved by the FDA for the treatment of adults with kidney cancer. Its use in patients with germ cell tumors is investigational. Up to 42 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Genitourinary Disease
- Being tested
- Sunitinib Malate
- Keywords
- Genitourinary, Testis, Refractory Germ Cell Tumors, Advanced germ cell tumors, GCTs, Sunitinib Malate, Sutent, SU011248
- Medical subject headings
- Urogenital Diseases, Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunitinib MalateDrug
Also called SU011248, Sutent
50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib Malate | Experimental | Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle. Receives: Drug: Sunitinib Malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate
Measurable disease or response recorded from start of treatment until disease progression/recurrence. Participants who die during therapy or are lost to follow-up shall be counted as progressive disease. Progressive disease defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Evaluation of measurable disease response follows Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Slow Accrual
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genitourinary DiseaseStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Lance Pagliaro, MD, BA, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912912
- Sponsor's protocol ID
- 2006-0685
- Other IDs
- NCI-2012-01645
- Status last verified
- Mar 2016
- First submitted
- 1 Jun 2009
- Last updated
- 15 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Subbiah V, Meric-Bernstam F, Mills GB, Shaw KR, Bailey AM, Rao P, Ward JF, Pagliaro LC. Next generation sequencing analysis of platinum refractory advanced germ cell tumor sensitive to Sunitinib (Sutent(R)) a VEGFR2/PDGFRbeta/c-kit/ FLT3/RET/CSF1R inhibitor in a phase II trial. J Hematol Oncol. 2014 Aug 1;7:52. doi: 10.1186/s13045-014-0052-x.
PubMed 25085632
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Sunitinib Malate in Refractory Germ Cell Tumors
- ClinicalTrials.gov ID
- NCT00912912
- Acronym / sponsor ID
- 2006-0685
- Conditions
- Genitourinary Disease
- Keywords
- Genitourinary, Testis, Refractory Germ Cell Tumors, Advanced germ cell tumors, GCTs, Sunitinib Malate, Sutent, SU011248
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Posted 27 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if Sutent® (sunitinib malate, SU011248) can control the disease in patients with germ cell tumors that are resistant to earlier treatment.
Detailed description
The Study Drug:
Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.
Within 14 days of enrollment on this study, you will have the following tests and procedures performed:
- Your complete medical history will be recorded.
- You will have a physical exam.
Within 7 days of enrollment on this study, you will have the following tests and procedures performed:
-Blood (about 3 teaspoons) and urine will be collected for routine testing and to test for certain biomarkers (to check the status of the disease).
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take sunitinib malate capsules once a day (by mouth) for 4 weeks in a row followed by 2 weeks with no study drug. These 6 weeks are considered 1 cycle of study treatment.
Study Visits:
On Day 1 of each cycle (about every 6 weeks), you will have the following tests done before you take the study drug:
- You will have a physical exam.
- You will be asked about how you are feeling and about any side effects you have experienced since your last visit.
- You will have blood (about 3 teaspoons) and urine collected for routine tests and to test for certain biomarkers.
For the first 4 weeks of treatment, you should have your blood pressure monitored. This may be done at your home with a digital pressure device, or you may visit your local doctor for this testing.
About Day 21 of Cycles 1 and 2, blood (about 2- 3 teaspoons) will be drawn for routine tests. This may be done at your local doctor's office and results faxed to the study doctor.
On Day 1 of Cycle 2, Day 1 of Cycle 3, and then Day 1 of every 2 cycles after that (Cycle 5, Cycle 7, and so on), you will have imaging scans to check status of the disease. This could include CT or MRI scans, an ECG, and a chest x-ray. If your doctor thinks it is necessary, you may have additional imaging scans at any time.
On Day 1 of every other cycle (Cycle 3, Cycle 5, and so on), you will have an echocardiogram or MUGA scan.
Length of Study:
You may remain on study for as long as you are benefitting. You will be taken off study if intolerable side effects occur or if the disease gets worse. However, if the disease gets worse very quickly during Cycles 1 or 2, you will be taken off study at that time.
Off-Study Visit:
When you are taken off of treatment on this study, the following tests and procedures will be performed:
- You will have a physical exam.
- You will be asked how you are feeling and about any changes in your medical history since beginning this study.
- You will also be asked about any side effects you have experienced since your last visit.
This is an investigational study. Sunitinib malate is approved by the FDA for the treatment of adults with kidney cancer. Its use in patients with germ cell tumors is investigational. Up to 42 patients will take part in this study. All will be enrolled at M. D. Anderson.
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 | Experimental | Drug: Sunitinib MalateSunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Progressive metastatic Germ-cell tumors (GCTs) of gonadal or extragonadal origin in males after failure of front-line therapy and at least one salvage regimen.
- Must have evaluable or measurable disease by clinical or radiological studies. Alternatively, in the absence of radiologically evaluable or measurable disease, two sequentially rising marker values each one week apart attributed by treating physician to germ cell tumor is permitted; either beta human chorionic gonadotropin (hCG) above 50 mIU/ml and/or alpha-fetoprotein (AFP) above 20 ng/ml qualifies as eligible.
- The Eastern Cooperative Oncology Group (ECOG) Performance Score 0-2
- Adequate organ function as follows: Calculated creatinine clearance >/= 35cc/min, Absolute neutrophil count >/= 1500/mm^3, hemoglobin >/= 8 g/dL, serum calcium </= 12 mg/dL, Platelet count >/= 75,000/mm^3, AST (SGOT)/ALT (SGPT) < 2.5 x upper limit of normal (ULN), Total bilirubin < 2.0mg/dl.
- Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade </= 2.
Key exclusion criteria (9 listed)
- NCI CTCAE Version 3.0 grade 3 hemorrhage within the 4 weeks prior to starting the study treatment.
- Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Patients with history of Long QT syndrome.
- Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade >/= 2.
- Uncontrolled Hypertension (> 140/90 mm Hg despite optimal medical therapy).
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 MalateAlso: SU011248, Sutent50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle. | Drug | Sunitinib Malate |
Primary outcome
12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate
Time frame: 12 weeks
Measurable disease or response recorded from start of treatment until disease progression/recurrence. Participants who die during therapy or are lost to follow-up shall be counted as progressive disease. Progressive disease defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Evaluation of measurable disease response follows Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25085632Subbiah V, Meric-Bernstam F, Mills GB, Shaw KR, Bailey AM, Rao P, Ward JF, Pagliaro LC. Next generation sequencing analysis of platinum refractory advanced germ cell tumor sensitive to Sunitinib (Sutent(R)) a VEGFR2/PDGFRbeta/c-kit/ FLT3/RET/CSF1R inhibitor in a phase II trial. J Hematol Oncol. 2014 Aug 1;7:52. doi: 10.1186/s13045-014-0052-x.
- University of Texas MD Anderson Cancer Center 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.
Lance Pagliaro, MD, BA study chair
M.D. Anderson Cancer Center
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 in people with Genitourinary Disease, run by M.D. Anderson Cancer Center 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 10 inclusion and 9 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 15 Apr 2016. 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 27 Jan 2016). 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?
12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00912912, which also lists 1 linked publication.
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 15 Apr 2016.