NCT05975944

Study of Selinexor Combined With Olaparib in Relapsed/Refractory Extensive Stage Small Cell Lung Cancer

A Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, and Efficacy of Selinexor Combined With Olaparib in the Treatment of Recurrent/Refractory Extensive-stage Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, single arm, open, non-randomized, dose-escalation/ expansion phase Ib/II clinical study. The dose-escalation part of phase Ib clinical trial was conducted according to the Bayesian Optimal Interval Design (BOIN), with a total of three dose groups: low, medium, and high. Dose level 1: Selinexor 40mg PO QW, Olaparib 150mg PO BID; Dose level 2: Selinexor 60mg PO QW, Olaparib 150mg PO BID; Dose level 3: Selinexor 80mg PO QW, Olaparib 150mg PO BID. The number of patients in each group is 3, with a maximum sample size of 9, to evaluate the safety and effectiveness of the medication, and to provide a basis for recommended phase II dose (RP2D). Eligible subjects received medication on the first day and then entered a 21 day observation period of dose-limiting toxicity (DLT). DLT is defined as the occurrence of level 3 non hematological toxicity or level 4 hematological toxicity. Evaluate the efficacy every 6 weeks. In this study, an independent Data Safety Monitoring Committee (DSMC) and an Independent Review Committee (IRC) were established to regularly review the safety and effectiveness data of each research center, with the aim of protecting subjects safety, ensuring the reliability of clinical trials and the objectivity of trial results.

Detailed description

This study is a multicenter, single arm, open, non-randomized, dose-escalation/ expansion phase Ib/II clinical study. The dose-escalation part of phase Ib clinical trial was conducted according to the Bayesian Optimal Interval Design (BOIN), with a total of three dose groups: low, medium, and high. Dose level 1: Selinexor 40mg PO QW, Olaparib 150mg PO BID; Dose level 2: Selinexor 60mg PO QW, Olaparib 150mg PO BID; Dose level 3: Selinexor 80mg PO QW, Olaparib 150mg PO BID. The number of patients in each group is 3, with a maximum sample size of 9, to evaluate the safety and effectiveness of the medication, and to provide a basis for recommended phase II dose (RP2D). Eligible subjects received medication on the first day and then entered a 21 day observation period of dose-limiting toxicity (DLT). DLT is defined as the occurrence of level 3 non hematological toxicity or level 4 hematological toxicity. Evaluate the efficacy every 6 weeks. In this study, an independent Data Safety Monitoring Committee (DSMC) and an Independent Review Committee (IRC) were established to regularly review the safety and effectiveness data of each research center, with the aim of protecting subjects safety, ensuring the reliability of clinical trials and the objectivity of trial results.

Conditions

• Extensive-stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Selinexor，Olaparib	Dose level 1: Selinexor 40mg PO QW, Olaparib 150mg PO BID; Dose level 2: Selinexor 60mg PO QW, Olaparib 150mg PO BID; Dose level 3: Selinexor 80mg PO QW, Olaparib 150mg PO BID.

Timeline

• Start date: 2023-09-01
• Primary completion: 2023-09-01
• Completion: 2024-05-01
• First posted: 2023-08-04
• Last updated: 2023-08-04

Locations

1 site across 1 country: China