NCT04698941

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

Clinical Study of Albumin Paclitaxel With or Without Simvastatin in Treating Extensive-Stage Small Cell Lung Cancer Patients Relapsed From First-line Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

PRIMARY OBJECTIVES: I.To assess disease control rate (DCR) after treatment. SECONDARY OBJECTIVES: I.To assess best overall response rate (ORR) after treatment. II.To evaluate the progression-free survival (PFS) of patients with extensive stage-small cell lung cancer (ES-SCLC) treated with albumin paclitaxel + simvastatin or with albumin paclitaxel alone. III.To estimate overall survival (OS) of patients with ES-SCLC. IV. To evaluate the toxicity profile of albumin paclitaxel + simvastatin. EXPLORATORY OBJECTIVES: I.To evaluate biomarkers correlatives. II.To explore the mechanism of albumin paclitaxel + simvastatin in the treatment of chemotherapy-resistant participants with ES-SCLC. OUTLINE: Patients are divided into two arms. ARM A: Participants received intravenous infusions of albumin paclitaxel 260 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle in combination with oral simvastatin (20mg daily) until persistent radiographic PD as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or symptomatic deterioration. ARM B:Participants received intravenous infusions of albumin paclitaxel 260 mg/m\^2 alone on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Albumin Paclitaxel	Albumin Paclitaxel intravenous infusion was administered at a dose of 260 mg/m\^2 on Day 1 of each 21-day cycle.
DRUG	Simvastatin	20mg daily oral tablet taken.

Timeline

• Start date: 2021-07-25
• Primary completion: 2021-12-30
• Completion: 2022-12-30
• First posted: 2021-01-07
• Last updated: 2021-07-29

Locations

2 sites across 1 country: China