Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117299
Status:
COMPLETED
Last Update Posted:
2010-05-27
First Post:
2005-06-30
Brief Title:
PTK787ZK222584 in the Treatment of Metastatic Gastrointestinal Stromal Tumors Resistant to Imatinib
Sponsor:
University of Helsinki
Organization:
University of Helsinki
Study Overview
Official Title:
A Phase II Open-Label Study of PTK787ZK222584 in the Treatment of Metastatic Gastrointestinal Stromal Tumors GISTs Resistant to Imatinib Mesylate
Status:
COMPLETED
Status Verified Date:
2010-05
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 study evaluates the safety and efficacy of a novel tyrosine kinase inhibitor PTK787ZK222584 in the treatment of GIST gastrointestinal stromal tumor that is resistant to imatinib mesylate Gleevec The study participants are required to have histologically confirmed GIST with prior imatinib treatment for metastatic GIST is administered orally 1250 mgday Six patients will first enter the study If clinical benefit is obtained in 1 of 6 patients 9 and 30 additional patients will be entered into the protocol in two stages a maximum of 45 patients will be entered Patients who benefit from the study treatment will be treated with PTK787ZK222584 until treatment failure
Detailed Description:
This is an open-label phase II study of PTK787ZK222584 designed to determine the safety and efficacy of PTK787ZK222584 in the treatment of imatinib-resistant GIST The PTK787ZK222584 dose used is 1250 mg daily Six patients will first enter the study using a two-stage approach If clinical benefit is obtained in 1 of 6 patients 9 and 30 additional patients will be entered into the protocol a maximum total number of 45 patients will be entered Clinical benefit is defined as the occurrence of one or more of the following 3 measures 1 objective response to PTK787 a confirmed or unconfirmed partial response PR or a complete response CR 2 metabolic response defined as 50 decrease in the standardized uptake value SUV of FDG uptake in 1 FDG-avid lesions in one or more of the patients or 3 stabilized disease for 3 months or longer accompanied by symptomatic or performance status improvement Medical history current medical conditions weight height and an electrocardiogram are recorded prior to the study entry Other baseline examinations include a chest X-ray hematologic tests a coagulation panel serum chemistries urine analysis a serum pregnancy test and a radiological assessment of the tumor Tumor response is monitored with imaging at 4- to 8-week intervals Hematological tests and serum chemistries are evaluated at 1- to 4-week intervals and adverse events are collected continuously Research blood tests are collected at the times of tumor evaluations Dose adjustments are carried out as per the protocol Patients who benefit from the study treatment will be treated with PTK787ZK222584 until treatment failure
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 |
|---|---|---|---|
| GIST PTK787ZK222584 | None | None | None |