This is a Phase 1 Study Evaluating the Safety of ABT-263 in Combination with Etoposide/Cisplatin in Subjects with Small Cell Lung Cancer (SCLC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
150mg of ABT-263 is taken daily for 3 out of 21 days. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
etoposide = 100 mg/m2 Days 1-3 of each Cycle; Max duration 6 cycles. cisplatin = 75 mg/m2 Day 1 of each Cycle; Max duration 6 cycles
Site Reference ID/Investigator# 13323
Chicago, Illinois, United States
Site Reference ID/Investigator# 12841
Maywood, Illinois, United States
Site Reference ID/Investigator# 12303
Baltimore, Maryland, United States
Site Reference ID/Investigator# 12305
Boston, Massachusetts, United States
Assess the safety profile of ABT-263 when administered in combination with etoposide/cisplatin in subjects with Cancer.
Time frame: Weekly
Characterize the pharmacokinetics of ABT-263 when administered in combination with etoposide/cisplatin .
Time frame: Weekly
Determine the maximum tolerable dose (MTD) of ABT-263 when administered in combination with etoposide/cisplatin.
Time frame: Weekly
Determine the recommended Phase 2 dose (RPTD) of ABT-263 when administered in combination with etoposide/cisplatin.
Time frame: Weekly
Evaluate preliminary data regarding progression free survival (PFS).
Time frame: Bi-monthly
Evaluate preliminary data regarding objective response rate (ORR).
Time frame: Bi-monthly
Evaluate preliminary data regarding time to tumor progression (TTP).
Time frame: Bi-monthly
Evaluate preliminary data regarding overall survival (OS).
Time frame: Bi-monthly
Evaluate preliminary data regarding duration of overall response.
Time frame: Bi-monthly
Evaluate preliminary data regarding Eastern Cooperative Oncology Group (ECOG) performance status.
Time frame: Bi-monthly
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Site Reference ID/Investigator# 20381
Boston, Massachusetts, United States
Site Reference ID/Investigator# 43505
Detroit, Michigan, United States
Site Reference ID/Investigator# 13322
New Brunswick, New Jersey, United States
Evaluate biomarkers
Define the relationship between disease state (related to patient selection and monitoring), B-Cell Lymphoma 2 (Bcl-2) family protein expression, and potential response to the proposed therapy ABT-263 and etoposide/cisplatin.
Time frame: Bi-monthly