A Phase 1/2 interventional study of Venetoclax 50 MG and Venetoclax 100 MG in Relapsed Small Cell Lung Cancer and Refractory Small Cell Lung Carcinoma, sponsored by Virginia Commonwealth University. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-03.
Sponsored by Virginia Commonwealth University · Phase 1/2, Interventional, and Treatment
This study is a single-arm, open-label, multicenter phase 1/2 trial designed to establish the recommended phase 2 dose (RP2D) of daily oral venetoclax when given in combination with irinotecan in patients with relapsed or refractory small cell lung cancer (SCLC).
Irinotecan will be given at 60 mg/m2 on days 1, 8, and 15 of each 28-day cycle. A 3+3 dose escalation design will be followed until the maximum tolerated dose (MTD) of venetoclax has been determined. Once the MTD is established, a RP2D that is the same as or less than the MTD will be determined. If no RP2D can be determined, the study will close to accrual. The RP2D will be used in an expansion cohort based on a Simon's two-stage minimax design to evaluate efficacy.
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Adequate bone marrow function as defined below:
Adequate hepatic function as defined below:
Persons with known HIV seropositivity are eligible if they meet the following criteria:
Exclusion Criteria:
Ongoing or planned treatment with any of the following:
Venetoclax 50mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15
Drug: Venetoclax 50 MG · Drug: Irinotecan 60 mg/m2
Venetoclax 100mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15
Drug: Venetoclax 100 MG · Drug: Irinotecan 60 mg/m2
Venetoclax 200mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15
Drug: Venetoclax 200 MG · Drug: Irinotecan 60 mg/m2
Venetoclax 400mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15
Drug: Venetoclax 400 · Drug: Irinotecan 60 mg/m2
Venetoclax 600mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15
Drug: Venetoclax 600 · Drug: Irinotecan 60 mg/m2
Venetoclax recommended phase 2 dose (RP2D) by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15
Drug: Irinotecan 60 mg/m2 · Drug: Venetoclax (RP2D)
Escalating doses to determine recommended phase 2 dose (RP2D)
Escalating doses to determine recommended phase 2 dose (RP2D)
Escalating doses to determine recommended phase 2 dose (RP2D)
Escalating doses to determine recommended phase 2 dose (RP2D)
Escalating doses to determine recommended phase 2 dose (RP2D)
Intravenously (IV), days 1, 8, and 15
orally, once per day
Phase 1: Determine the recommended phase 2 dose (RP2D) of venetoclax with irinotecan in patients with relapsed or refractory SCLC
Recommended phase 2 dose (RP2D) of venetoclax in combination with irinotecan that is less than or equal to the maximum tolerated dose (MTD). A 3+3 dose escalation design will be followed until the maximum tolerated dose (MTD) of venetoclax has been determined. Patients assigned to a dose level of venetoclax greater than 50 mg will undergo a ramp-up phase during the first week of irinotecan
Time frame: 90 Days
Phase 2: Evaluate the efficacy of venetoclax with irinotecan in patients with relapsed or refractory SCLC
The RP2D will be used in an expansion cohort based on a Simon's two-stage minimax design to evaluate efficacy.
Time frame: 180 Days
Assess the frequency of adverse events (AEs)
Assess adverse events (AEs) characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE V 5.0) to determine safety and toxicity of the combination of venetoclax and irinotecan.
Time frame: 120 Days
Evaluate the antitumor effects of venetoclax and irinotecan in combination.
Evaluate the anti tumor effects of tumor response based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Time frame: 180 Days
Observe survival in relapsed or refractory SCLC patients receiving venetoclax in combination with irinotecan
Progression-free survival and overall survival of patients with relapsed or refractory SCLC receiving venetoclax in combination with irinotecan
Time frame: 180 Days
No study locations are listed for this record.
This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University