NCT04543916

Venetoclax and Irinotecan in Relapsed/Refractory SCLC

A Phase 1/2 Study of Venetoclax and Irinotecan in Relapsed/Refractory Small Cell Lung Cancer

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Venetoclax 50 MG	Escalating doses to determine recommended phase 2 dose (RP2D)
DRUG	Venetoclax 100 MG	Escalating doses to determine recommended phase 2 dose (RP2D)
DRUG	Venetoclax 200 MG	Escalating doses to determine recommended phase 2 dose (RP2D)
DRUG	Venetoclax 400	Escalating doses to determine recommended phase 2 dose (RP2D)
DRUG	Venetoclax 600	Escalating doses to determine recommended phase 2 dose (RP2D)
DRUG	Irinotecan 60 mg/m2	Intravenously (IV), days 1, 8, and 15
DRUG	Venetoclax (RP2D)	orally, once per day

Timeline

• Start date: 2021-06-30
• Primary completion: 2028-05-30
• Completion: 2028-06-30
• First posted: 2020-09-10
• Last updated: 2021-03-03

Regulatory

• FDA-regulated drug study