11-MULTI-12-OPI/CRAB (11-001) Ph. 1b/II Trial: Carfilzomib w/ Irinotecan in Small Cell LC Pts Who Progressed on prior plat. chemo

Grants and Contracts Details

Description

Confidential Human Clinical Trial UK PI Initiated Study (1 of 4 contarcts - Membership Agreement with CRAB, Tri-Party Agreement wtih Onyx, CRAB and UKRF for funding, Site Agreement for UKRF and CRAB [this account], and Lab Services [Leggas Account MIS# 201309201036] CRAB CTC Study Number: 11-001 Version 4.0 Date of Original Protocol: January 17 , 2013 Amendment #1: April 30, 2013 Study Title: Phase 1b/II Trial of Carfilzomib with Irinotecan in Irinotecan-Sensitive Malignancies (Phase Ib) and Small Cell Lung Cancer Subjects (Phase II) Who Have Progressed on Prior Platinum-based Chemotherapy (Onyx IST Reference Number: CAR-IST-553) IND Number: 117350 Institution Name: CRAB Clinical Trials Consortium (multi-site study) Principal Investigator Information: Name: Susanne M. Arnold, MD Address: 800 Rose Street, cc445; Lexington, KY 40536 Phone No: 859-323-8043 Fax No: 859-257-7715 Email Address: [email protected] PROTOCOL SYNOPSIS TITLE: CTC 11-001: Phase 1b/II Trial of Carfilzomib with Irinotecan in Irinotecan-Sensitive Malignancies (Phase Ib) and Small Cell Lung Cancer Subjects (Phase II) Who Have Progressed on Prior Platinum-based Chemotherapy (Onyx IST Reference Number: CAR-IST-553) OBJECTIVES: Primary Objectives: Phase 1b: Determine maximum tolerated dose (MTD) of Carfilzomib (Day 1, 2, 8, 9, 15, and 16) in combination with Irinotecan (Days 1, 8 and 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers. Phase II: Assess 6 month survival of relapsed small cell lung cancer subjectsubjects treated with this combination therapy. Secondary Objectives: Phase 1b: Response rate, safety/tolerability, biomarker endpoints (see below). Biomarker testing to occur for all subjects in Phase 1b. Phase II: response rate, safety/tolerability, progression-free survival and biomarker endpoints: „X Chymotrypsin-like activity in PBMC (LMP7 and b5 activity) as a measure of carfilzomib¡¦s effect on proteasome activity in 15 subjectsubjects in each stratum. „X Topoisomerase-I protein expression as a measure of carfilzomib¡¦s capacity to prevent irinotecan induced topoisomerase-I degradation in 15 subjects in each stratum. „X Gamma-H2AX protein expression in PBMC, as a measure of irinotecan-mediated DNA damage and as a measure of carfilzomib¡¦s capacity to prevent irinotecan induced topoisomerase-I degradation in 15 subjects in each stratum. o Topoisomerase-I expression by immunohistochemistry will be determined in banked tissue, if available, in all subjects, as a biomarker of response. STUDY DESIGN: Study Design: 1. Phase 1b: standard 3+3 design using five dose levels of Carfilzomib. 2. Phase II: Single arm trial of this therapy (using the MTD as
StatusFinished
Effective start/end date9/15/1311/13/19

Funding

  • Cancer Research and Biostatistics: $204,613.00

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