NCT03227016

Study in Patients With SCLC of Veliparib in Combination With Topotecan

Phase I/II Study in Patients With Small Cell Lung Cancer (SCLC) of Veliparib in Combination With Topotecan

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Central European Society for Anticancer Drug Research · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Phase I/II Study in Patients With Small Cell Lung Cancer (SCLC) of Veliparib in Combination With Topotecan

Detailed description

For this study sensitive or refractory SCLC patients (refractory to prior chemotherapy defined as having experienced no response or a relapse within 90 days after the end of chemotherapy) will be eligible. In total, around 130 patients will be enrolled, around 30 evaluable patients in phase I and 100 patients in phase II. The study will consist of two parts: A preceding Phase I part will be performed to identify the Recommended Dose of veliparib to be administered in the Phase II part in combination with topotecan at the dose regimen of 1.25 mg/m2 (on days 1-5 of a 3 week cycle \[d1-5q21d\]). Each patient will be subjected to an initial cycle of topotecan monotherapy (1.25 mg/m2 on day 1-5 of a 3 week cycle); this run-in cycle shall prove topotecan tolerance of the candidates. Only patients who do not reveal any DLTs receive further treatment with combination therapy. In a dose-escalating 3+3 design the RD of veliparib for the subsequent Phase II part of the study will be defined during a maximum of 5 cycles combination therapy. The Phase II part will follow upon completion of Phase I.

Conditions

• Small Cell Lung Cancer SCLC

Interventions

Type	Name	Description
DRUG	veliparib	Topotecan at increasing doses (1x or 2x per day) will be administered in each cycle.
DRUG	Topotecan	Topotecan at dose 1.25 mg/m2 will be administered in each cycle.

Timeline

• Start date: 2016-10-01
• Primary completion: 2021-05-01
• Completion: 2021-06-01
• First posted: 2017-07-24
• Last updated: 2021-01-27

Locations

1 site across 1 country: Germany