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Venetoclax and Irinotecan in Relapsed/Refractory SCLC

NCT04543916 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-03-03

No results posted yet for this study

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).

Conditions

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

Interventions

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

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Sosipatros Boikos, MD · Massey Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2028-05-30
Completion
2028-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04543916 on ClinicalTrials.gov