Efficacy Study of CYT997 in Combination With Carboplatin in Glioblastoma
NCT00650949 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2013-05-03
Summary
This study seeks to (i) determine the safe dose of CYT997 when given in combination with carboplatin in patients with relapsed glioblastoma multiforme (glioma) and (ii) to determine whether the combination of CYT997 with carboplatin is a useful treatment for glioma.
Conditions
Interventions
- DRUG
-
CYT997
Escalating doses (100mg/m\^2 to 150mg/m\^2), 24-hour intravenous infusion on Day 2 of a 21-day cycle (Phase Ib component). Dose selected in Phase Ib component to be used for Phase II component.
- DRUG
-
Intravenous infusion over 1 hour at area under the concentration-time curve (AUC)=5 on Day 1 of a 21-day cycle
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Jason Lickliter, MD · Peninsula Health
-
Helen Wheeler, MD · Royal North Shore Hospital
-
Ganessan Kichenadasse, MD · Flinders Medical Centre
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-11-30
- Primary Completion
- 2011-06-30
- Completion
- 2011-06-30
Countries
- Australia
Study Locations
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