Chemo-refractory MelanomaPhase 2NCT01216657
Trial of Single Agent Sunitinib for Patients With Chemo-refractory Metastatic Melanoma
A Phase 2 study testing Sunitinib in people with Chemo-refractory Melanoma, run by Krankenhaus Nordwest at 1 site in Germany.
Trial summary
Sunitinib is a novel small molecule receptor tyrosine kinase inhibitor with direct antitumor effects as well as antiangiogenetic activity. Preclinical and clinical data for Sunitinib and data about angiogenesis and growth regulation in melanoma suggest the activity of Sunitinib in melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemo-refractory Melanoma
- What is being tested?
- Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to May 2013
- 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
- Male and female patients aged 18 years and older.
- Diagnosis of unresectable (Stage III) or metastatic (Stage IV), histologically or cytologically proven, melanoma without clinically meaningful surgical or radiotherapeutical options except for mucosal or ocular origin of the primary tumor.
- Subjects must have completed a first or second line chemotherapy or be progressed under chemotherapeutic treatment. The previous treatment must have included DTIC alone or in combination
- Performance status of 0 to 2 on the ECOG scale
- Life expectancy > 12 weeks.
- Patients must be able to swallow Sunitinib capsules.
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- Evidence of measurable disease according to the RECIST criteria
- Prior radiation therapy allowed if completed at least 2 weeks and any major surgery allowed if completed at least 4 weeks prior to first dose of Sunitinib.
- Resolution of all acute toxic side effects of prior therapy or surgical procedures to grade < 1 NCI-CTC (except for laboratory values).
- Adequate organ function including the following:
- platelets > 100 x 109/L
- hemoglobin > 8 g/dl
- absolute neutrophils count (AGC) > 1.5 x 109/L.
- Hepatic:
- bilirubin <=1.5 times upper limit of normal (ULN)
- aspartate transaminase (AST) and alanine transaminase (ALT) <=2.5 times normal (AST and ALT <=5.0 times normal is acceptable if liver function abnormalities are due to underlying malignancy).
- INR < 1.5 or a PTT within normal limits.
- Subjects must not have any evidence of a bleeding diathesis.
- Renal:
- Serum creatinine < 1.5 x ULN
- serum calcium < 1.2 mg/dl.
- Pancreatic:
- Serum lipase and amylase within normal range.
- Signed and dated informed consent
Who cannot join
- Prior treatment with ras-raf-MEK-ERK signaling pathway inhibitors (including trastuzumab, sorafenib, farnesyl transferase inhibitors or MEK inhibitors), or treatment with drugs which target VEGF (such as bevacizumab).
- Radiotherapy, except palliative radiotherapy during study participation as described.
- Known active infection (i.e. HIV, chronic hepatitis B or C, at the discretion of the investigator)
- History of organ allograft or stem cell transplantation.
- Coexisting second malignancy (excluding basal or squamous cell carcinoma of the skin, superficial bladder cancer and in situ carcinoma of the cervix with no evidence of recurrence) or history of prior malignancy
- Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (> hemicolectomie or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis.
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- Current history of chronic diarrhea defined as persisting diarrhea for more than 3 weeks at study entry due to any reason.
- Any of the following events prior to starting the trial treatment: *clinically evident congestive heart failure, as defined by New York Health Association (NYHA) > class II
- Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2
- Atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females.
- Subjects on beta-blockers and digoxin must be monitored closely
- QT-interval > 450 msec
- Risk factors for torsade-de-pointes-tachycardia (i.e.. Hypokalaemia, congenital Long-QT-syndrome)
- Active coronary artery disease or ischemia (myocardial infarction within the last 6 months prior to study entry)
- Coronary/peripheral artery bypass graft
- Cerebrovascular accident or transient ischemic attack
- Active disseminated intravascular coagulation, or history of clinically significant bleeding within the past 6 months, including gross hemoptysis or haematuria, or underlying coagulopathy
- Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with trial participation or trial drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial.
- Participation in any other clinical trial within the last 3 weeks.
- Pregnant or lactating women.
- Known allergic/hypersensitivity reaction to any of the components of the treatment, or known drug abuse/alcohol abuse.
- Active CNS metastatic or meningeal tumors.
- Patients with seizure disorders requiring medication (such as antiepileptics, the use of carbamazepine, phenytion an phenobarbital is prohibited).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Uncontrolled Phase II Trial of Single Agent Sunitinib (SU 11248) for Patients With Chemo-refractory Metastatic Melanoma
Sunitinib is a novel small molecule receptor tyrosine kinase inhibitor with direct antitumor effects as well as antiangiogenetic activity. Preclinical and clinical data for Sunitinib and data about angiogenesis and growth regulation in melanoma suggest the activity of Sunitinib in melanoma. This study will investigate the efficacy, safety and tolerability of Sunitinib as palliative treatment in chemo-refractory metastatic melanoma.
Read the detailed description
This is a single agent 2-step phase 2 study with a one-year follow-up to evaluate the antitumor activity of Sunitinib administered in treatment cycles of 6 weeks duration (4 weeks treatment and 2 weeks rest) in patients with chemo-refractory melanoma. If the first step shows sufficient efficacy and tolerability the study will continue to step 2. Treatment will continue for 9 months or until disease progression or until intolerable adverse events occur. Subsequently the patients will be followed up for 1 year. Tumor assessment will be performed at baseline, at the end of cycle 1,2,3 and subsequently at the end of every uneven cycle (5,7,9,…).
A total of 40 patients will be enrolled in this trial.
- Conditions
- Chemo-refractory Melanoma
- Being tested
- Sunitinib
- Keywords
- melanoma, sunitinib
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
50 mg oral, daily, for 4 weeks, then 2 weeks without treatment, repeat at d43
| Study group | Role | What they receive |
|---|---|---|
| sunitinib | Experimental | 50 mg Sunitinib daily for 4 weeks, then 2 weeks without treatment Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical benefit rate cycle 1-3
clinical benefit rate defined as a CR + PR + SD > 4 months duration
Measured: tumor assessment every 6 weeks
clinical benefit rate cycle 4 and more
clinical benefit rate defined as a CR + PR + SD > 4 months duration
Measured: tumor assessment every 12 weeks
Secondary outcomes (4)
response rate cycle 1-3
response rate defined as CR+PR
Measured: tumor assessment every 6 weeks
progression free survival
Measured: follow-up one year
overall survival
Measured: follow-up for one year
response rate cycle 4 and more
response rate defined as CR+PR
Measured: every 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startMar 2009
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemo-refractory MelanomaStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elke Jäger, Prof. Dr., Principal investigator, Krankenhaus Nordwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216657
- Sponsor's protocol ID
- S379 SUMA
- Status last verified
- Jun 2013
- First submitted
- 12 Apr 2010
- Last updated
- 4 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Uncontrolled Phase II Trial of Single Agent Sunitinib (SU 11248) for Patients With Chemo-refractory Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01216657
- Acronym / sponsor ID
- S379 SUMA
- Conditions
- Chemo-refractory Melanoma
- Keywords
- melanoma, sunitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Krankenhaus NordwestUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 Oct 2010 (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.
Sunitinib is a novel small molecule receptor tyrosine kinase inhibitor with direct antitumor effects as well as antiangiogenetic activity. Preclinical and clinical data for Sunitinib and data about angiogenesis and growth regulation in melanoma suggest the activity of Sunitinib in melanoma. This study will investigate the efficacy, safety and tolerability of Sunitinib as palliative treatment in chemo-refractory metastatic melanoma.
Detailed description
This is a single agent 2-step phase 2 study with a one-year follow-up to evaluate the antitumor activity of Sunitinib administered in treatment cycles of 6 weeks duration (4 weeks treatment and 2 weeks rest) in patients with chemo-refractory melanoma. If the first step shows sufficient efficacy and tolerability the study will continue to step 2. Treatment will continue for 9 months or until disease progression or until intolerable adverse events occur. Subsequently the patients will be followed up for 1 year. Tumor assessment will be performed at baseline, at the end of cycle 1,2,3 and subsequently at the end of every uneven cycle (5,7,9,…).
A total of 40 patients will be enrolled in this trial.
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: Sunitinib50 mg Sunitinib daily for 4 weeks, then 2 weeks without treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Male and female patients aged 18 years and older.
- Diagnosis of unresectable (Stage III) or metastatic (Stage IV), histologically or cytologically proven, melanoma without clinically meaningful surgical or radiotherapeutical options except for mucosal or ocular origin of the primary tumor.
- Subjects must have completed a first or second line chemotherapy or be progressed under chemotherapeutic treatment. The previous treatment must have included DTIC alone or in combination
- Performance status of 0 to 2 on the ECOG scale
- Life expectancy > 12 weeks.
Key exclusion criteria (24 listed)
- Prior treatment with ras-raf-MEK-ERK signaling pathway inhibitors (including trastuzumab, sorafenib, farnesyl transferase inhibitors or MEK inhibitors), or treatment with drugs which target VEGF (such as bevacizumab).
- Radiotherapy, except palliative radiotherapy during study participation as described.
- Known active infection (i.e. HIV, chronic hepatitis B or C, at the discretion of the investigator)
- History of organ allograft or stem cell transplantation.
- Coexisting second malignancy (excluding basal or squamous cell carcinoma of the skin, superficial bladder cancer and in situ carcinoma of the cervix with no evidence of recurrence) or history of prior malignancy
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 |
|---|---|---|
| Sunitinib50 mg oral, daily, for 4 weeks, then 2 weeks without treatment, repeat at d43 | Drug | sunitinib |
Primary outcome
clinical benefit rate cycle 1-3
Time frame: tumor assessment every 6 weeks
clinical benefit rate defined as a CR + PR + SD > 4 months duration
clinical benefit rate cycle 4 and more
Time frame: tumor assessment every 12 weeks
clinical benefit rate defined as a CR + PR + SD > 4 months duration
4 secondary outcomes
response rate cycle 1-3
Time frame: tumor assessment every 6 weeks
progression free survival
Time frame: follow-up one year
overall survival
Time frame: follow-up for one year
response rate cycle 4 and more
Time frame: every 12 weeks
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
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.
Elke Jäger, Prof. Dr. principal investigator
Krankenhaus Nordwest
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 Chemo-refractory Melanoma, run by Krankenhaus Nordwest at 1 site in Germany.
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 24 inclusion and 24 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 Jun 2013. 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 Germany. 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: slow recruitment). 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?
clinical benefit rate cycle 1-3 (time frame: tumor assessment every 6 weeks). The study lists 2 primary outcomes in all. 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 Jun 2013.