drugset / Trial / NCT01941316

Study of Carfilzomib With Irinotecan in Irinotecan-Sensitive Malignancies and Small Cell Lung Cancer Patients

NCT01941316

Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to determine a well-tolerated dose of Carfilzomib in combination with Irinotecan (Phase 1b portion of the study) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers and to assess the 6 month survival of relapsed small cell lung cancer patients treated with this combination therapy. \*\*The Phase 1b portion of the study is now complete\*\*. Phase 2 portion of the study. The safest, maximally tolerated dose established as established in Phase 1 for Phase 2 is as follows -- Carfilzomib will be provided at 20/36 mg/m\^2 with Irinotecan dosed at 125 mg/m\^2. The purpose of the Phase 2 portion of the study is to assess 6 month survival of relapsed small cell lung cancer ins subjects treated with this combination therapy.

Timeline

Start
2013-11
Primary completion
2018-12-31
Completion
2019-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Carfilzomib Other / unclassified 27 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 36 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 45 mg/m2 Intravenous
Subject Irinotecan Small molecule 125 mg/m2 Intravenous