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- Klinische proef NCT01216657
Trial of Single Agent Sunitinib for Patients With Chemo-refractory Metastatic Melanoma
An Open-label, Uncontrolled Phase II Trial of Single Agent Sunitinib (SU 11248) for Patients With Chemo-refractory Metastatic Melanoma
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Frankfurt/Main, Duitsland, 60488
- Krankenhaus Nordwest
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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.
- 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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: sunitinib
50 mg Sunitinib daily for 4 weeks, then 2 weeks without treatment
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50 mg oral, daily, for 4 weeks, then 2 weeks without treatment, repeat at d43
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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clinical benefit rate cycle 1-3
Tijdsspanne: tumor assessment every 6 weeks
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clinical benefit rate defined as a CR + PR + SD > 4 months duration
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tumor assessment every 6 weeks
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clinical benefit rate cycle 4 and more
Tijdsspanne: tumor assessment every 12 weeks
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clinical benefit rate defined as a CR + PR + SD > 4 months duration
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tumor assessment every 12 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
response rate cycle 1-3
Tijdsspanne: tumor assessment every 6 weeks
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response rate defined as CR+PR
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tumor assessment every 6 weeks
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progression free survival
Tijdsspanne: follow-up one year
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follow-up one year
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overall survival
Tijdsspanne: follow-up for one year
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follow-up for one year
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response rate cycle 4 and more
Tijdsspanne: every 12 weeks
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response rate defined as CR+PR
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every 12 weeks
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Elke Jäger, Prof. Dr., Krankenhaus Nordwest
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Neuro-endocriene tumoren
- Nevi en melanomen
- Melanoma
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Proteïnekinaseremmers
- Sunitinib
Andere studie-ID-nummers
- S379 SUMA
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Chemo-refractory Melanoma
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Tang-Du HospitalXijing Hospital; Sun Yat-sen University; Shaanxi Provincial People's Hospital; Air... en andere medewerkersVoltooidHCC | Resectie | Transarteriële chemo-embolisatie
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Vanderbilt University Medical CenterVoltooidBorstkanker | Chemotherapie-gerelateerde cognitieve stoornissen | Chemo mist | Chemo hersenen | ChemobreinVerenigde Staten
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Peking University Cancer Hospital & InstituteNog niet aan het wervenHCC | Regorafenib | Transarteriële chemo-embolisatie | Hepatische arteriële infusiechemotherapie
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Beijing 302 HospitalWervingStereotactische lichaamsstralingstherapie | Transkatheter arteriële chemo-embolisatie | Grote HCC-patiëntenChina
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UNC Lineberger Comprehensive Cancer CenterEunice Kennedy Shriver National Institute of Child Health and Human Development...VoltooidCognitieve achteruitgang | Chemo-breinVerenigde Staten
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University of Alabama at BirminghamNog niet aan het wervenGynaecologische kanker | Chemotherapie-effect | Chemo-brein | Kankergerelateerde cognitieve problemen
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Joseph McCollomIndiana University School of MedicineWervingCognitieve beperking | Cognitieve disfunctie | Cognitieve verandering | Chemotherapie-effect | Cognitieve achteruitgang | Chemo-brein | Neoplasmata, colorectaal | Chemo mistVerenigde Staten
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National Taiwan University HospitalVoltooidLeverkanker | Transkatheter arteriële chemo-embolisatieTaiwan
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Sichuan Cancer Hospital and Research InstituteNog niet aan het wervenDEB-TACE gecombineerd met apatinib en PD-1 voor de behandeling van intrahepatisch cholangiocarcinoomIntrahepatisch cholangiocarcinoom | Apatinib | PD-1 antilichaam | Transarteriële chemo-embolisatieChina
Klinische onderzoeken op Sunitinib
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AGO Study GroupPhilipps University Marburg Medical Center; HSK Reasearch GmbH WiesbadenVoltooidPlatina refractaire epitheliale eierstokkanker | Primaire kanker van het peritoneum | Kanker van de eileiderDuitsland
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Cogent Biosciences, Inc.WervingUitgezaaide kanker | Geavanceerde gastro-intestinale stromale tumorenVerenigde Staten, Korea, republiek van, Spanje, Verenigd Koninkrijk, Australië, Frankrijk, Italië, Nederland, Taiwan, Duitsland, Denemarken, Hongkong, Canada, Zweden, Noorwegen, Mexico, Tsjechië, Argentinië, Hongarije, Brazilië, ... en meer
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)VoltooidNierkankerVerenigde Staten
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PfizerVoltooidBorstneoplasmataVerenigde Staten
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PfizerVoltooidGastro-intestinale stromale tumorenKorea, republiek van
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California Pacific Medical Center Research InstitutePfizer; University of California, San FranciscoVoltooidGemetastaseerd melanoomVerenigde Staten
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National Cancer Institute (NCI)VoltooidStadium I multipel myeloom | Stadium II multipel myeloom | Stadium III Multipel Myeloom | Refractair multipel myeloomVerenigde Staten
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Asan Medical CenterVoltooidGemetastaseerd niercelcarcinoomKorea, republiek van
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National Cancer Institute (NCI)VoltooidTerugkerend kwaadaardig mesothelioom | Geavanceerd maligne mesothelioomCanada
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National Cancer Institute (NCI)VoltooidMyelodysplastische syndromen | Chronische myelomonocytische leukemie | Secundaire myelodysplastische syndromen | de Novo Myelodysplastische syndromenCanada, Verenigde Staten