Phase I Chinese PK

NCT ID: NCT00503711

Last Updated: 2016-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

An open, phase 1 to assess the PK of rising doses of ZD6474 when administered daily in Chinese patients with advanced solid malignant tumors.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid, Malignant Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

100 mg Vandetanib eod

100 mg Vandetanib every other day dosing

Group Type EXPERIMENTAL

Vandetanib

Intervention Type DRUG

100 mg every other day, 100mg once daily

100 mg Vandetanib od

100 mg Vandetanib once daily dosing

Group Type EXPERIMENTAL

Vandetanib

Intervention Type DRUG

100 mg every other day, 100mg once daily

300 mg Vandetanib od

300 mg Vandetanib once daily dosing

Group Type EXPERIMENTAL

Vandetanib 300 mg

Intervention Type DRUG

300mg once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vandetanib

100 mg every other day, 100mg once daily

Intervention Type DRUG

Vandetanib 300 mg

300mg once daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ZD6474 ZACTIMA™ ZD6474 ZACTIMA™

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Guangzhou, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21600385 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D4200L00004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

6MW3511 in Patients With Advanced Solid Tumor
NCT05524194 UNKNOWN PHASE1/PHASE2
AMT-116 in Patients with Solid Tumors
NCT06782334 RECRUITING PHASE1/PHASE2
SG2918 For Advanced Malignant Tumors
NCT06167486 RECRUITING PHASE1