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
Status | Finished |
---|---|
Effective start/end date | 9/15/13 → 11/13/19 |
Funding
- Cancer Research and Biostatistics: $204,613.00
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