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- Klinische proef NCT00649207
A Phase I Study of ABT-888 in Combination With Conventional Whole Brain Radiation Therapy (WBRT) in Cancer Patients With Brain Metastases
A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of ABT-888 in Combination With Whole Brain Radiation Therapy in Subjects With Brain Metastases
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Toronto, Canada, M5G 2M9
- Site Reference ID/Investigator# 18542
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Ponce, Puerto Rico, 00716
- Site Reference ID/Investigator# 46322
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Site Reference ID/Investigator# 8334
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Illinois
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Chicago, Illinois, Verenigde Staten, 60611
- Site Reference ID/Investigator# 52462
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Kansas
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Kansas City, Kansas, Verenigde Staten, 66160
- Site Reference ID/Investigator# 24483
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21231-2410
- Site Reference ID/Investigator# 7180
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Michigan
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Detroit, Michigan, Verenigde Staten, 48202-2689
- Site Reference ID/Investigator# 19021
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19111
- Site Reference ID/Investigator# 6344
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Wisconsin
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Madison, Wisconsin, Verenigde Staten, 53792
- Site Reference ID/Investigator# 6653
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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:
- Age is greater than or equal to 18 years.
- Histologically or cytologically confirmed non-CNS primary solid malignancy.
- Pathologically or radiographically confirmed metastatic disease in the brain. Subjects with non-measurable lesions, including leptomeningeal carcinomatosis, are eligible.
- WBRT is clinically indicated, with the exception of prophylactic treatment.
- Karnofsky Performance Status (KPS) greater than or equal to a score of 70.
- Adequate hematology, renal and hepatic function.
Both men and women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and up to 2 months following completion of protocol therapy.
- Total abstinence from sexual intercourse (minimum one complete menstrual cycle)
- A vasectomized partner * Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration
- Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream)
- Subject is capable of understanding and complying with parameters as outlined in the protocol.
- Subject or the subject's legally acceptable representative has voluntarily signed and dated the informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Exclusion Criteria:
- Brain metastases secondary to germ cell tumor or lymphoma malignancy.
- Primary central nervous system (CNS) neoplasm.
Prior or concurrent administration of the following therapies or treatments:
- Prior treatment with WBRT
- SRS performed less than 14 days prior to WBRT D1, or is scheduled to occur within 30 days of the last WBRT session
- Last dose of chemotherapy, immunotherapy, biologic therapy, or investigational therapy was less than 14 days prior to WBRT D1. Bisphosphonates, hormone modification therapy, and trastuzumab are permitted without restriction
- Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment.
- Known seizure disorder (status epileptics) that is uncontrolled, or seizures occurring greater than or equal to 3 times a week over the past month.
- If female, subject is pregnant or breast-feeding.
Clinically significant and uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or neurological/psychiatric disease or disorder, including but not limited to:
- Active uncontrolled infection
- Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- Any other illness condition(s) that could exacerbate potential toxicities, confound safety assessments, require excluded therapy for management, or limit compliance with study requirements
- Unable to swallow and retain oral medications.
Known contraindication to enhanced MRI and CT, including but not limited to:
- Presence of metal objects within the body such as a cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or shrapnel
- History of immediate or delayed hypersensitivity reaction or other contraindication to contrast agents including but not limited to gadolinium and iodine
- Previous enrollment in this study or another study involving the investigation of ABT-888, with the exception of receiving a single dose of study drug.
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-888 and/or WBRT.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 1
This is an open label study; therefore, there are no numbered/labeled study arms. This is a dose escalation study, ABT-888 dose will be escalated in conjunction with two schedules of whole brain radiation therapy (WBRT). Subjects may be treated WBRT for 3 weeks (15 days) or 2 weeks (10 days). |
Oral Capsules
Andere namen:
15 fractions of 2.5 Gy over 3 weeks to a total dose of 37.5 GY or 10 fractions of 3.0 Gy over 2 weeks to a total dose of 30 Gy
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Determine the maximum tolerated dose of ABT-888 in combination with whole brain radiation therapy
Tijdsspanne: ABT-888 will be dose escalated until the largest dose is reached that is felt to be safe based on safety information from all subjects.
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ABT-888 will be dose escalated until the largest dose is reached that is felt to be safe based on safety information from all subjects.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Safety Assessment Physical and Neurological Exam
Tijdsspanne: be performed at all study visits, final and follow-up visit
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be performed at all study visits, final and follow-up visit
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Safety Assessment Mini-Mental State Examination
Tijdsspanne: be performed at all study visits, final and follow-up visit
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be performed at all study visits, final and follow-up visit
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Safety Assessment Laboratory testing
Tijdsspanne: be performed at all study visits, final and follow-up visit
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Chemistry and Hematology labs will be collected
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be performed at all study visits, final and follow-up visit
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Shepherd L Stacie, MD, AbbVie
Publicaties en nuttige links
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 (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Neoplasmata per site
- Neoplastische processen
- Neoplasmata van het centrale zenuwstelsel
- Neoplasmata
- Neoplasma metastase
- Ziekten van het zenuwstelsel
- Hersenneoplasmata
- Hersenziekten
- Neoplasmata van het zenuwstelsel
- Ziekten van het centrale zenuwstelsel
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Poly (ADP-ribose) polymeraseremmers
- Veliparib
Andere studie-ID-nummers
- M10-128
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 Hersenziekten
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Assistance Publique Hopitaux De MarseilleOnbekendBrain Awake ChirurgieFrankrijk
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University of Dublin, Trinity CollegeOnbekendBrain Health Gepensioneerde topsporters
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Medical University of ViennaVoltooidPerioperatief | Brain Natriuretisch Peptide | Aanvullende zuurstof | HartrisicopatiëntenOostenrijk
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Hospices Civils de LyonVoltooidPosterior Brain Fossa-tumoren bij kinderenFrankrijk
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Kartal Kosuyolu Yuksek Ihtisas Education and Research...Trakya University Faculty of Medicine HospitalVoltooidHartoperatie | Desfluraan | Cardiopulmonale bypass | Coronaire Bypass Graft Chirurgie | Brain Natriuretisch Peptide | Resultaat
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GE HealthcareCovance; i3 StatprobeVoltooidBrain Fibrillarab-niveausVerenigde Staten
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First Affiliated Hospital Xi'an Jiaotong UniversityVoltooidHartinfarct | Revalidatie | Brain-computer-interfaceChina
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Assiut UniversityVoltooidBrain Voxel-gebaseerde morfometrie in manieEgypte
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Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyBeëindigdChronisch hartfalen | Hoog B-type (of Brain) Natriuretic Peptide (BNP) niveau in het bloedDuitsland, Frankrijk, Nederland
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University of FloridaVoltooidBrain Imaging van Placebo-analgesieVerenigde Staten
Klinische onderzoeken op ABT-888
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National Cancer Institute (NCI)VoltooidRecidiverend eileidercarcinoom | Recidiverend ovariumcarcinoom | Recidiverend primair peritoneaal carcinoom | Borstcarcinoom | Ovariumcarcinoom | Pancreascarcinoom | Prostaatcarcinoom | Recidiverend mammacarcinoom | Oestrogeenreceptor negatief | HER2/Neu-negatief | Progesteronreceptor negatief | Triple-negatief... en andere voorwaardenVerenigde Staten
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National Cancer Institute (NCI)NRG OncologyVoltooidRecidiverend eileidercarcinoom | Recidiverend ovariumcarcinoom | Recidiverend primair peritoneaal carcinoom | BRCA1-mutatiedrager | BRCA2-mutatiedrager | Ovariële epitheliale tumorVerenigde Staten
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AbbVie (prior sponsor, Abbott)Prostate Cancer Clinical Trials ConsortiumVoltooid
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National Cancer Institute (NCI)Actief, niet wervendGeavanceerd maligne solide neoplasmaVerenigde Staten
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Radiation Therapy Oncology GroupNational Cancer Institute (NCI); NRG OncologyVoltooidHersenen en tumoren van het centrale zenuwstelselVerenigde Staten
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National Cancer Institute (NCI)VoltooidRecidiverend eileidercarcinoom | Recidiverend ovariumcarcinoom | Recidiverend primair peritoneaal carcinoom | Peritoneale carcinomatose | Volwassen vast neoplasmaVerenigde Staten, Canada
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Georgetown UniversityAbbottOnbekendUitgezaaide alvleesklierkankerVerenigde Staten
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Northwestern UniversityBristol-Myers Squibb; National Cancer Institute (NCI); AbbVieOnbekendInoperabel solide neoplasma | Terugkerend solide neoplasma | Refractair mantelcellymfoom | Agressief non-Hodgkin-lymfoom | Geavanceerd solide neoplasma | T-cel non-Hodgkin-lymfoomVerenigde Staten
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AbbVieNiet meer beschikbaarHoogwaardige sereuze eierstokkanker | Vaste tumoren met gedocumenteerde BRCA, BARD of PALB of andere acceptabele DNA-mutaties of afwijkingen die wetenschappelijk verantwoord zijn | Triple negatieve borstkanker (TNBC) | Patiënten die Veliparib-suspensieformulering nodig hebben