A study consisting of a dose-escalation phase and a dose-expansion phase to evaluate the safety, tolerability, pharmacokinetics, and efficacy of venetoclax in combination with atezolizumab, carboplatin, and etoposide.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Venetoclax will be administered orally at escalating doses from 200mg to 800mg as 100mg tablets as per the dosing schedules described above.
Atezolizumab will be administered via intravenous (IV) infusion at a fixed dose of 1200mg as per the dosing schedules described above.
Carboplatin will be administered via IV infusion at a dose of 5mg/mL/min as per the dosing schedules described above.
Emory University
Atlanta, Georgia, United States
Rigshospitalet; Onkologisk Klinik
København Ø, Denmark
Severance Hospital, Yonsei University Health System
Seoul, South Korea
ICO I Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet ICO
L'Hospitalet de Llobregat, Barcelona, Spain
Number of Participants With Adverse Events (AEs)
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Baseline up until 30 days after the last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to a maximum of 6.5 weeks).
Overall Response Rate (ORR)
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Up to 24 months
Duration of Response (DOR)
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Up to 24 months
Progression Free Survival (PFS)
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Up to 24 months
Overall Survival (OS) After Enrolment
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Up to 49 months
Progression Free Survival (PFS) Rate at 6 Months
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Etoposide will be administered via IV infusion at a dose of 100mg/m\^2 as per the dosing schedules described above.
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
Madrid, Spain
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Up to 18 months
Overall Survival (OS) Rate at 1 Year
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Up to 18 months
Plasma Concentrations (ng/mL) of Venetoclax at Specified Timepoints
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Up to 24 months
Serum Concentrations (ng/mL) of Atezolizumab at Specified Timepoints
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Up to 24 months
Plasma Concentrations (ng/mL) of Carboplatin at Specified Timepoints
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Up to 24 months
Plasma Concentrations (ng/mL) of Etoposide at Specified Timepoints
The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time frame: Up to 24 months