Venetoclax and Irinotecan in Relapsed/Refractory SCLC

Sponsor
Virginia Commonwealth University
Study ID
NCT04543916
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Refractory Small Cell Lung Carcinoma
  • Relapsed Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Jun 30, 2021
Status verified
Mar 2021
Primary completion
May 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1
    Venetoclax 50mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15
  • Experimental: Dose Level 2
    Venetoclax 100mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15
  • Experimental: Dose Level 3
    Venetoclax 200mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15
  • Experimental: Dose Level 4
    Venetoclax 400mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15
  • Experimental: Dose Level 5
    Venetoclax 600mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15
  • Experimental: Phase 2 Expansion Cohort
    Venetoclax recommended phase 2 dose (RP2D) by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15

Primary Outcome Measure

Phase 1: Determine the recommended phase 2 dose (RP2D) of venetoclax with irinotecan in patients with relapsed or refractory SCLC [ Time Frame: 90 Days ]

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