Advanced Solid, Malignant Tumors Clinical Trial
Official title:
An Open Label, Phase I, Rising Multiple Dose, Single Centre Study to Determine the PK and Tolerability of ZD6474 at Different Dose Levels in Chinese Patients With Solid Malignancy Tumor
Verified date | August 2016 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
An open, phase 1 to assess the PK of rising doses of ZD6474 when administered daily in Chinese patients with advanced solid malignant tumors.
Status | Completed |
Enrollment | 36 |
Est. completion date | November 2007 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - histological and/or cytological confirmation of a malignant solid tumor - refractory to standard therapies or for which no appropriate therapies exist - WHO performance status 0-2 Exclusion Criteria: - patients with brain tumors or symptomatic cerebral metastases - systemic anticancer therapy within the last 4 weeks |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Research Site | Guangzhou |
Lead Sponsor | Collaborator |
---|---|
Genzyme, a Sanofi Company |
China,
Zhang L, Li S, Zhang Y, Zhan J, Zou BY, Smith R, Martin PD, Jiang Y, Liao H, Guan Z. Pharmacokinetics and tolerability of vandetanib in Chinese patients with solid, malignant tumors: an open-label, phase I, rising multiple-dose study. Clin Ther. 2011 Mar;33(3):315-27. doi: 10.1016/j.clinthera.2011.04.005. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the curve (AUC) (0-24) (ng.h/mL) after single dose | Blood sample is collected at 1, 2, 4, 6, 8, 10 & 24 hour after first single dose on day 1 | No |