AzTrials
AzTrials

SarcomaPhase 2NCT00117299

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

A Phase 2 study testing PTK787/ZK222584 in people with Sarcoma, run by University of Helsinki at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma
What is being tested?
PTK787/ZK222584
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteFinland
Study dates
Sep 2004to Jan 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Helsinki University Central Hospital

    Helsinki, FIN-00029

Other trials in Finland

About this study

Official title: A Phase II, Open-Label Study of PTK787/ZK222584 in the Treatment of Metastatic Gastrointestinal Stromal Tumors (GISTs) Resistant to Imatinib Mesylate

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.

Read the detailed description

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.

Conditions
Sarcoma
Being tested
PTK787/ZK222584
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
Medical subject headings
Sarcoma, Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PTK787/ZK222584Drug

    Also called vatalanib

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

Study groups in NCT00117299
Study groupRoleWhat they receive
AExperimentalPTK/ZK o.d. 1250 mg p.o.
Receives: Drug: PTK787/ZK222584

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2005 (estimated)
  2. Study startSep 2004
  3. Primary completionSep 2007
  4. Study completionJan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00117299
Sponsor's protocol ID
CPTK787 A2401/300267
Other IDs
GIST PTK787/ZK222584
Status last verified
May 2010
First submitted
30 Jun 2005
Last updated
27 May 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PTK787/ZK222584 in people with Sarcoma, run by University of Helsinki at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00117299.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in