Dose-finding Study of Abraxane in Combination With Cisplatin to Treat Advanced Nasopharyngeal Carcinoma
NCT01735409 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 69
Last updated 2014-01-28
Summary
This is a single center, non-randomized phase IIa study to determine the tolerance and safety of Abraxane (ABX) in combination with cisplatin (DDP) in patients with advanced nasopharyngeal carcinoma (NPC). Patients in whom the standard therapy had failed or had been infeasible will be eligible.The safety and efficacy will be evaluated according to NCI-CTCAE V4.0 and RECIST 1.1 respectively.
Conditions
- Nasopharyngeal Neoplasms
Interventions
- DRUG
-
ABX + DDP
ABX 260 mg/m2 day 1 + DDP 75mg/m2 day 1
- DRUG
-
ABX + DDP
ABX 140 mg/m2 day 1,8 + DDP 75mg/m2 day 1
- DRUG
-
ABX + DDP
ABX 100 mg/m2 day 1,8,15 + DDP 75mg/m2 day 1
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Li Zhang, MD · Sun Yat-sen University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2014-03-31
- Completion
- 2014-06-30
Countries
- China
Study Locations
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