PTK787/ZK222584 in the Treatment of Metastatic Gastrointestinal Stromal Tumors Resistant to Imatinib

NCT00117299 | Completed Phase 2

• 2 other identifiers: CPTK787 A2401/300267GIST PTK787/ZK222584
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety and efficacy of a novel tyrosine kinase inhibitor, PTK787/ZK222584, 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 mg/day. 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 PTK787/ZK222584 until treatment failure.

Conditions

Sarcoma

Keywords

Gastrointestinal stromal tumor; GIST; Sarcoma; PTK787; ZK 222584; Tyrosine kinase inhibitor; Tyrosine kinase; VEGF; Vascular endothelial growth factor; VEGFR; Vascular endothelial growth factor receptor; KDR; KIT; c-KIT; Platelet derived growth factor receptor; PDGFR

Outcome Measures

Primary Outcomes (1)

• Response rate

  1 year

Study Arms (1)

A

EXPERIMENTAL

PTK/ZK o.d. 1250 mg p.o.

Drug: PTK787/ZK222584

Interventions

PTK787/ZK222584 DRUG

PTK787/ZK222584 is administered at the dosage of 1250 mg o.d. orally

Also known as: vatalanib

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed GIST
• Imatinib resistance (primary resistance with progression, or progression after initial response). Resistance is defined as objective evidence of progression after at least 4 weeks of treatment with imatinib.
• Imatinib therapy has been interrupted \>7 days before study entry
• Metastatic disease confirmed histologically, cytologically or radiologically
• Presence of measurable tumor lesions as determined by RECIST criteria
• Age 18 years or older
• WHO performance status of 2 or less
• Blood neutrophil count (ANC) 1.5 x 10\^9/L or higher
• Platelet count 100 x 10\^9/L or higher
• Serum bilirubin 1.5 x ULN (upper limit of normal) or less
• Serum creatinine 2.0 x ULN or less
• Written informed consent obtained according to local guidelines

You may not qualify if:

• Patients who have received chemotherapy less than 4 weeks prior to entry into this study or who have not recovered from side effects of such therapy
• Patients who have received a cumulative dose of doxorubicin \>450 mg/m2 or epirubicin 800 mg/m2
• Patients who have received immunotherapy within 2 weeks or who have not recovered from side effects of such therapy
• Patients who have received radiotherapy within 2 weeks or who have not recovered from side effects of such therapy
• Major surgery within 2 weeks prior to entry into this study or patients who have not recovered from side effects of such therapy
• Patients who have received investigational drugs within 4 weeks prior to entry into this study or who have not recovered from side effects of such therapy
• Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control
• Concurrent severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months, poorly controlled hypertension, history of labile hypertension, history of poor compliance with antihypertensive regimen, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study
• Acute or chronic liver disease (e.g., hepatitis, cirrhosis)
• Confirmed diagnosis of HIV infection
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK222584 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow the capsules/tablets)
• Patients who are taking Coumadin (warfarin sodium); heparin is acceptable.
• Patients unwilling to, or unable to, comply with the protocol

Sponsors & Collaborators

• University of Helsinki: lead
• Bayer: collaborator

Study Sites (1)

Helsinki University Central Hospital

Helsinki, FIN-00029, Finland

Location

MeSH Terms

Conditions

Sarcoma; Gastrointestinal Stromal Tumors

Interventions

vatalanib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Heikki Joensuu, M.D.

  Department of Oncology, Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 6, 2005
• Study Start: September 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: January 1, 2009
• Last Updated: May 27, 2010

Record last verified: 2010-05

Locations

FI (1)