kurzprotokoll suma

KURZPROTOKOLL
SUMA
Öffentlicher Titel
Sunitinib bei chemo-refraktärem metastasierten Melanom
Wissenschaftl. Titel
An open-label, uncontrolled phase II trial of single agent Sunitinib (SU 11248) for
patients with chemo-refractory metastatic melanoma
Kurztitel
SUMA
Studienart
prospektiv, offen/unverblindet, einarmig, Investigator Initiated Trial (IIT)
Studienphase
Phase II
Erkrankung
DERMA: Melanom: Zweitlinie oder höher
Ziele
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clinical benefit rate
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response rate (CR + PR) duration of response duration of stable disease progression
-free survival (PFS) time to progressive disease (TTP) effect on survival toxicity
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Male and female patients aged 18 years and older.
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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.
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Subjects must have completed a first or second line chemotherapy or be progressed
under chemotherapeutic treatment
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The previous treatment must have included DTIC alone or in combination
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Performance status of 0 to 2 on the ECOG scale
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Life expectancy > 12 weeks.
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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.
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Resolution of all acute toxic side effects of prior therapy or surgical procedures to
grade < 1 NCI-CTC (except for laboratory values).
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Adequate organ function including the following:
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a. platelets > 100 x 109/L
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b. hemoglobin > 8 g/dl
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c. absolute neutrophils count (AGC) > 1.5 x 109/L.
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Hepatic:
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a. bilirubin <=1.5 times upper limit of normal (ULN) aspartate transaminase (AST)
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b. 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).
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c. INR < 1.5 or a PTT within normal limits.
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Subjects must not have any evidence of a bleeding diathesis.
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Renal:
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a. Serum creatinine < 1.5 x ULN
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b. serum calcium < 1.2 mg/dl.
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Pancreatic:
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i. Serum lipase and amylase within normal range.
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Signed and dated informed consent
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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).
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Radiotherapy, except palliative radiotherapy during study participation as described.
Einschlusskriterien
Ausschlusskriterien
© Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt
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KURZPROTOKOLL
SUMA
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Known active infection (i.e. HIV, chronic hepatitis B or C, at the discretion of the
investigator)
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History of organ allograft or stem cell transplantation.
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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.
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Any of the following events prior to starting the trial treatment:
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i. *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.
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Subjects on beta-blockers and digoxin must be monitored closely QT-interval > 450
msec
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Risk factors for torsade-de-pointes-tachycardia (i.e.. Hypokalaemia, congenital LongQT-syndrome)
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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
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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).
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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.
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Participation in any other clinical trial within the last 3 weeks.
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Pregnant or lactating women.
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Known allergic/hypersensitivity reaction to any of the components of the treatment, or
known drug abuse/alcohol abuse.
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Active CNS metastatic or meningeal tumors.
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Patients with seizure disorders requiring medication (such as antiepileptics, the use
of carbamazepine, phenytion an phenobarbital is prohibited).
Alter
18 Jahre und älter
Status
Geschlossen
Beginn der Rekrutierung
01.03.2009
Sponsoren
Krankenhaus Nordwest (Hauptsponsor)
Förderer
Krankenhaus Nordwest
Registrierung in anderen
Studienregistern
ClinicalTrials NCT01216657 (primäres Register)
EUDRACT 2007-002828-15
Therapie
Sunitinib
© Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt
Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de
Stand: 15.01.2017; Seite 2 von 2