Ignite Creation Date:
2024-05-05 @ 11:49 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01427322
Status:
TERMINATED
Last Update Posted:
2015-07-08
First Post:
2011-08-30
Brief Title:
Randomized RT - Lapatinib for Advanced Solid Tumor Cancer Patients Receiving Radiation Therapy for Metastatic Disease
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
A Randomized Study of Lapatinib With Radiation Versus Radiation Alone in Advanced Solid Tumor Cancer Patients Receiving Radiation Therapy for Metastatic Disease
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lapatinib will prevent radiation-induced increase in Transforming Growth Factor alpha TGFα an important growth factor in cancer cell recovery after ionizing irradiation
Detailed Description:
Lapatinib is an orally bioavailable small molecule inhibitor of ERBB1 and ERBB2 HER2 It is currently indicated for use in patients with HER2 over-expressing metastatic breast cancer Serum increases in TGFα can have growth potentiating effects on distant sites of metastatic disease Palliative irradiation paradoxically may promote distant tumor growth blocking shedding of TGFα from irradiated tumors may prevent this effect and improve the therapeutic index of radiation therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-02734 | REGISTRY | CTRP | None |