Combined Simvastatin and Irinotecan in Treating ES-SCLC Patients Relapsed From 1st Chemotherapy

Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Study ID
NCT04985201
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Irinotecan intravenous infusion was administered at a dose of 60 mg/m\^2 on Day 1,8 of each 21-day cycle.
  • Simvastatin — DRUG
    Simvastatin 40 mg daily oral tablet taken.

Study Details

This Phase II study was designed to evaluate the safety and efficacy of irinotecan in combination with simvastatin compared with treatment with irinotecan alone in ES-SCLC patients relapsed from first-line chemotherapy. Participants will be divided in a 1:1 ratio to receive either irinotecan (4 cycles) + simvastatin (10 months) or irinotecan (4 cycles) until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

Key Dates

Start date
Nov 1, 2021
Status verified
Aug 2021
Primary completion
Dec 1, 2022
Completion
Aug 1, 2023

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Simvastatin + Irinotecan
    received intravenous infusions of Irinotecan 60 milligrams per square meter (mg/m\^2) on Day 1,8 of every 21-day cycle (4 cycles) in combination with oral simvastatin (20mg daily) (10 months)
  • Active Comparator: Irinotecan
    received intravenous infusions of Irinotecan 60 milligrams per square meter (mg/m\^2) on Day 1,8 of every 21-day cycle (4 cycles)

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 12 weeks ]

Central Contacts

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