A Phase II, Open-Label Study of PTK787/ZK222584 in the Treatment of Metastatic Gastrointestinal Stromal Tumors (GISTs) Resistant to Imatinib Mesylate
This is an open-label, phase II study of PTK787/ZK222584 designed to determine the safety
and efficacy of PTK787/ZK222584 in the treatment of imatinib-resistant GIST. The
PTK787/ZK222584 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 PTK787/ZK222584 until treatment failure.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate
1 year
No
Heikki Joensuu, M.D.
Principal Investigator
Department of Oncology, Helsinki University Central Hospital
Finland: Finnish Medicines Agency
CPTK787 A2401/300267
NCT00117299
September 2004
January 2009
Name | Location |
---|