A Phase 1/2a Study of ABT-263 in Subjects With Small Cell Lung Cancer (SCLC) or Other Non-Hematological Malignancies
NCT ID: NCT00445198
Last Updated: 2018-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
86 participants
INTERVENTIONAL
2007-04-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1 and Phase 2a
ABT-263
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
Interventions
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ABT-263
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Locations
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Site Reference ID/Investigator# 13605
Peoria, Arizona, United States
Site Reference ID/Investigator# 5261
Phoenix, Arizona, United States
Site Reference ID/Investigator# 11942
Los Angeles, California, United States
Site Reference ID/Investigator# 4718
Sacramento, California, United States
Site Reference ID/Investigator# 3755
Aurora, Colorado, United States
Site Reference ID/Investigator# 8324
Atlanta, Georgia, United States
Site Reference ID/Investigator# 2623
Chicago, Illinois, United States
Site Reference ID/Investigator# 2625
Baltimore, Maryland, United States
Site Reference ID/Investigator# 12343
Bethesda, Maryland, United States
Site Reference ID/Investigator# 11941
Boston, Massachusetts, United States
Site Reference ID/Investigator# 2626
Boston, Massachusetts, United States
Site Reference ID/Investigator# 4934
Charlotte, North Carolina, United States
Site Reference ID/Investigator# 2624
Nashville, Tennessee, United States
Site Reference ID/Investigator# 6650
Tacoma, Washington, United States
Site Reference ID/Investigator# 7493
Edmonton, , Canada
Site Reference ID/Investigator# 7635
Ottawa, , Canada
Site Reference ID/Investigator# 18541
Leicester, , United Kingdom
Site Reference ID/Investigator# 2622
Manchester, , United Kingdom
Countries
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References
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Gandhi L, Camidge DR, Ribeiro de Oliveira M, Bonomi P, Gandara D, Khaira D, Hann CL, McKeegan EM, Litvinovich E, Hemken PM, Dive C, Enschede SH, Nolan C, Chiu YL, Busman T, Xiong H, Krivoshik AP, Humerickhouse R, Shapiro GI, Rudin CM. Phase I study of Navitoclax (ABT-263), a novel Bcl-2 family inhibitor, in patients with small-cell lung cancer and other solid tumors. J Clin Oncol. 2011 Mar 1;29(7):909-16. doi: 10.1200/JCO.2010.31.6208. Epub 2011 Jan 31.
Other Identifiers
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2006-003298-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M06-822
Identifier Type: -
Identifier Source: org_study_id
NCT00929513
Identifier Type: -
Identifier Source: nct_alias
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