Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT01552356
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2012-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pazopanib Hydrochloride in Treating Patients With Advanced or Refractory Solid Tumors
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Pharmacokinetic-Driven Individualization of Pazopanib Therapy in Patients With Solid Tumors: A Phase I Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the side effects and the best dose of pazopanib hydrochloride in treating patients with solid tumors that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or does not respond to treatment (refractory). Pazopanib hydrochloride may prevent the growth of new blood vessels that tumors need to grow. Studying samples of blood in the laboratory from patients receiving pazopanib hydrochloride may help doctors learn more about the effects of the body on the drug. It may also help doctors understand how well patients respond to treatment.
Detailed Description:
PRIMARY OBJECTIVES:
I. To assess the feasibility and safety of individualizing pazopanib (pazopanib hydrochloride) monotherapy based upon attained pazopanib plasma concentrations so as to achieve desired target pazopanib plasma concentration in the highest possible fraction of treated patients.
SECONDARY OBJECTIVES:
I. To assess whether patient cytochrome P450 (CYP) or other polymorphisms may correlate with attained pazopanib levels in response to standard pazopanib dosing.
II. To assess whether patient trough pazopanib levels attained 24 hours after initiation of 800 mg daily fasting may predict steady state trough pazopanib levels after 14 days of pazopanib administration.
III. To assess whether patient trough pazopanib levels may correlate with observed pazopanib toxicities.
OUTLINE: This is a dose-escalation study.
Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Course length can be extended to 56 days at the discretion of the treating physician after 12 courses (1 year) of treatment on study.
After completion of study treatment, patients are followed up for 3 months.
I. To assess the feasibility and safety of individualizing pazopanib (pazopanib hydrochloride) monotherapy based upon attained pazopanib plasma concentrations so as to achieve desired target pazopanib plasma concentration in the highest possible fraction of treated patients.
SECONDARY OBJECTIVES:
I. To assess whether patient cytochrome P450 (CYP) or other polymorphisms may correlate with attained pazopanib levels in response to standard pazopanib dosing.
II. To assess whether patient trough pazopanib levels attained 24 hours after initiation of 800 mg daily fasting may predict steady state trough pazopanib levels after 14 days of pazopanib administration.
III. To assess whether patient trough pazopanib levels may correlate with observed pazopanib toxicities.
OUTLINE: This is a dose-escalation study.
Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Course length can be extended to 56 days at the discretion of the treating physician after 12 courses (1 year) of treatment on study.
After completion of study treatment, patients are followed up for 3 months.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-00690 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| MAYO-MC1112 | None | None | View | |
| CDR0000727235 | None | None | View | |
| MC1112 | None | None | View | |
| MC1112 | OTHER | Mayo Clinic in Rochester | View | |
| 9076 | OTHER | CTEP | View | |
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA069912 | NIH | None | https://reporter.nih.gov/quic… | View |
| UM1CA186686 | NIH | None | https://reporter.nih.gov/quic… | View |