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Orantinib

Protein Kinase Inhibitors

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Patients receive oral SU6668 twice daily on days 1-28. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression of 100% or more.

Cohorts of at least 6 patients receive escalating doses of SU6668 until the OBD is determined. Once the OBD is reached, dose escalation continues until the maximum tolerated dose (MTD) is determined (if possible). The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

orantinib

laboratory biomarker analysis

pharmacological study

Roy Herbst

Phase I trial to study the effectiveness of SU6668 in treating patients who have advanced solid tumors. SU6668 may stop the growth of solid tumors by stopping blood flow to the tumor

OBJECTIVES:

I. Determine the optimal biologically effective dose of SU6668 in patients with advanced solid tumors.

II. Assess the safety and tolerability of this therapy in these patients. III. Determine the pharmacokinetic profile and interpatient pharmacologic variability of this therapy in these patients.

IV. Determine the extent, frequency, and duration of any tumor responses in patients treated with this therapy.

V. Determine a recommended phase II dose of SU6668 for future clinical studies.

OUTLINE: This is a dose-escalation study.

Patients receive oral SU6668 twice daily on days 1-28. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression of 100% or more.

Cohorts of at least 6 patients receive escalating doses of SU6668 until the optimal biologically effective dose (OBD) is determined. Once the OBD is reached, dose escalation continues until the maximum tolerated dose (MTD) is determined (if possible). The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

SU6668 in Treating Patients With Advanced Solid Tumors

A Phase I Surrogate Endpoint Trial of SU6668 in Patients With Incurable Solid Tumors

A mixed-effects analysis of variance (ANOVA) model will be used, and a fixed-effects model in which the same polynomial is fit for each patient will be used.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
SU6668 in Treating Patients With Advanced Solid Tumors	NCT00024206	Unspecified Adu...	orantinib laboratory biom... pharmacological...	18 Years -	National Cancer Institute (NCI)
SU6668 in Treating Patients With Advanced Solid Tumors	NCT00024206	Unspecified Adu...	orantinib laboratory biom... pharmacological...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for orantinib

Every month we try and update this database with for orantinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for orantinib

Every month we try and update this database with for orantinib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for orantinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.