A Phase 1/2a Study of ABT-263 in Subjects With Small Cell Lung Cancer (SCLC) or Other Non-Hematological Malignancies
1 juni 2018 bijgewerkt door: AbbVie (prior sponsor, Abbott)
A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects With Small Cell Lung Cancer or Other Non-Hematological Malignancies
The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 with the objective of defining the dose limiting toxicity and maximum tolerated dose.
(This portion of the study is complete).
The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
86
Fase
- Fase 2
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Edmonton, Canada, T6G 1Z2
- Site Reference ID/Investigator# 7493
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Ottawa, Canada, K1H 8L6
- Site Reference ID/Investigator# 7635
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Leicester, Verenigd Koninkrijk, LE1 5WW
- Site Reference ID/Investigator# 18541
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Manchester, Verenigd Koninkrijk, M20 4BX
- Site Reference ID/Investigator# 2622
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Arizona
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Peoria, Arizona, Verenigde Staten, 85381
- Site Reference ID/Investigator# 13605
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Phoenix, Arizona, Verenigde Staten, 85013
- Site Reference ID/Investigator# 5261
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California
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Los Angeles, California, Verenigde Staten, 90095-7187
- Site Reference ID/Investigator# 11942
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Sacramento, California, Verenigde Staten, 95817
- Site Reference ID/Investigator# 4718
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045-0510
- Site Reference ID/Investigator# 3755
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Site Reference ID/Investigator# 8324
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Illinois
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Chicago, Illinois, Verenigde Staten, 60612
- Site Reference ID/Investigator# 2623
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21231-1000
- Site Reference ID/Investigator# 2625
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Bethesda, Maryland, Verenigde Staten, 20892
- Site Reference ID/Investigator# 12343
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02215
- Site Reference ID/Investigator# 11941
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Boston, Massachusetts, Verenigde Staten, 02215
- Site Reference ID/Investigator# 2626
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28204
- Site Reference ID/Investigator# 4934
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37203
- Site Reference ID/Investigator# 2624
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Washington
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Tacoma, Washington, Verenigde Staten, 98405
- Site Reference ID/Investigator# 6650
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- The subject must be >=18 years of age.(Phase 1 & 2a)
- Histologically and/or cytologically documented diagnosis of small cell lung cancer (North America & UK) or other non-hematological malignancy (North America only).(Phase 1 only)
- Histologically and/or cytologically documented diagnosis of SCLC.(Phase 2a)
- At least one prior chemotherapy treatment regimen(s) and their disease is refractory or experienced progressive disease following the treatment.(Phase 1)
- Extensive-stage SCLC & is chemotherapy naïve(US only) has experienced progressive disease following at least one chemotherapy regimen or their disease is refractory.(Phase 2a)
- Brain metastases with clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function & no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug.
- ECOG performance score <= 2(Ph 1) <=1(Phase 2a)
- Must be receiving a stable dose of Selective Serotonin Reuptake Inhibitor (SSRI) anti-depressants 21 days prior to 1st dose of study drug.
Adequate bone marrow, renal & hepatic function per local lab reference range at Screening as follows:
- Bone marrow: Absolute Neutrophil count (ANC)>=1000/µL
- Platelets>= 100,000/mm3
- Hemoglobin>=9.0g/dL
- Renal function: Serum creatinine<= 2.0mg/dL or calculated creatinine clearance>=50mL/min
- Hepatic function&enzymes: AST and ALT<=3.0 x the upper normal limit(ULN) of institution's normal range
- Bilirubin<=1.5xULN. If Gilbert's Syndrome may have Bilirubin> 1.5 x ULN
- Coagulation: aPTT and PT<=1.2 x the upper limit of normal
- Should have archived diagnostic tissue available for assessment of Bcl-2 family protein expression.(Phase 2a)
- All female subjects not surgically sterile or postmenopausal(for at least 1 year)and non-vasectomized male subject must practice at least one method of birth control.
Exclusion Criteria:
- Underlying or predisposing condition of bleeding or currently exhibits signs of bleeding.
- Recent history of non-chemotherapy induced thrombocytopenia associated bleeding within 1 year prior to first dose of study drug.
- Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
- The subject has active immune thrombocytopenic purpura (ITP),active autoimmune hemolytic anemia (AIHA), or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
- Currently receiving or requires anticoagulation therapy or any drug or herbal supplements that affect platelet function, with exception of low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter.
- Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (with the exception of hormones for hypothyroidism or estrogen replacement therapy (ERT), anti estrogen analogs, agonists required to suppress serum testosterone levels), or any investigational therapy within 14 days prior to the first dose of study drug, or has not recovered to less than a grade 2 adverse effect(s) of the previous therapy.
- Received a biologic (G-CSF, GM-CSF or erythropoietin) within 28 days prior to the first dose of study drug.
- Steroid therapy for anti-neoplastic intent within seven days prior to the first dose of study drug.
- Has consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
- Significant history of cardiovascular disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
- Positive for HIV
A history of other active malignancies within the past 3 years prior to screening, with the exception of:
- Adequately treated in situ carcinoma of the cervix uteri
- Basal or squamous cell carcinoma of the skin
- Previous malignancy confined and surgically resected with curative intent
Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Active systemic fungal infection
- Diagnosis of fever and neutropenia within 1 week prior to study drug administration.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
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: Phase 1 and Phase 2a
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Phase 1 dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing. - 50 patients with SCLC and non-hematologic malignancies. Enrollment is closed in this arm of the study. Phase 2a dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing. - 40 patients with SCLC |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Safety assessment
Tijdsspanne: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Dose limiting toxicity determination
Tijdsspanne: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Maximum tolerated dose determination
Tijdsspanne: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Pharmacokinetic profile evaluation
Tijdsspanne: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Extended safety assessment at the recommended Phase 2 dose
Tijdsspanne: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Preliminary efficacy assessment
Tijdsspanne: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2007
Primaire voltooiing (Werkelijk)
1 december 2010
Studie voltooiing (Werkelijk)
1 december 2010
Studieregistratiedata
Eerst ingediend
6 maart 2007
Eerst ingediend dat voldeed aan de QC-criteria
6 maart 2007
Eerst geplaatst (Schatting)
8 maart 2007
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 juni 2018
Laatste update ingediend die voldeed aan QC-criteria
1 juni 2018
Laatst geverifieerd
1 januari 2013
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- M06-822
- 2006-003298-28 (EudraCT-nummer)
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 .