A Phase 1/2a Study of ABT-263 in Subjects With Small Cell Lung Cancer (SCLC) or Other Non-Hematological Malignancies
1. juni 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
86
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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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, Det Forenede Kongerige, LE1 5WW
- Site Reference ID/Investigator# 18541
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Manchester, Det Forenede Kongerige, M20 4BX
- Site Reference ID/Investigator# 2622
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Arizona
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Peoria, Arizona, Forenede Stater, 85381
- Site Reference ID/Investigator# 13605
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Phoenix, Arizona, Forenede Stater, 85013
- Site Reference ID/Investigator# 5261
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California
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Los Angeles, California, Forenede Stater, 90095-7187
- Site Reference ID/Investigator# 11942
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Sacramento, California, Forenede Stater, 95817
- Site Reference ID/Investigator# 4718
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Colorado
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Aurora, Colorado, Forenede Stater, 80045-0510
- Site Reference ID/Investigator# 3755
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Site Reference ID/Investigator# 8324
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Site Reference ID/Investigator# 2623
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Maryland
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Baltimore, Maryland, Forenede Stater, 21231-1000
- Site Reference ID/Investigator# 2625
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Bethesda, Maryland, Forenede Stater, 20892
- Site Reference ID/Investigator# 12343
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Site Reference ID/Investigator# 11941
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Boston, Massachusetts, Forenede Stater, 02215
- Site Reference ID/Investigator# 2626
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28204
- Site Reference ID/Investigator# 4934
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Site Reference ID/Investigator# 2624
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Washington
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Tacoma, Washington, Forenede Stater, 98405
- Site Reference ID/Investigator# 6650
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Safety assessment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Extended safety assessment at the recommended Phase 2 dose
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2007
Primær færdiggørelse (Faktiske)
1. december 2010
Studieafslutning (Faktiske)
1. december 2010
Datoer for studieregistrering
Først indsendt
6. marts 2007
Først indsendt, der opfyldte QC-kriterier
6. marts 2007
Først opslået (Skøn)
8. marts 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. juni 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juni 2018
Sidst verificeret
1. januar 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- M06-822
- 2006-003298-28 (EudraCT nummer)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .