PTK787 in Refractory or Relapsed Diffuse Large Cell Lymphoma

Stopped early · Phase 2

Conditions studied: Lymphoma, Large-Cell, Diffuse

In brief

This is a phase II open label study to assess the efficacy and safety of PTK787/ZK222584 in adults with relapsed or refractory diffuse large cell lymphoma (DLCL). All subjects will receive PTK787/ZK222584. Subjects who tolerate the study target dose of 1250mg will remain on that dose until study completion at 12 months or until disease progression, unacceptable toxicity, withdrawal of consent or non-compliance with the protocol requirement.

Key facts

Study ID

NCT00511043

Run by

David Rizzieri, MD

People needed

20

Starts

2005-11-01

Expected to finish

2010-06-01

Last updated by the study team

2014-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed DLCL (de novo or transformed).
• Measurable/evaluable disease by radiographs, physical exam or bone marrow involvement.
• Refractory disease, induction chemotherapy failure or relapsed disease.
• Age ≥ 18 years old
• Performance Status:KPS ≥ 70
• Laboratory tests as specified by the protocol.
• Written informed consent

You may not qualify if…

• History of known central nervous system disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis).
• History of another primary malignancy ≤ 5 years, with the exception of inactive basal or squamous cell carcinoma of the skin
• Prior chemotherapy ≤ 3 weeks prior to registration. There is no limit to the number of prior chemotherapy regimens.
• Prior allogeneic transplant if >2.5% donor cells remain by engraftment studies (prior autologous transplant is allowed)
• Prior biologic or immunotherapy ≤ 2 weeks prior to registration.
• Prior full field (total organ site) radiotherapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to registration.
• Major surgery (i.e., laparotomy) ≤ 4 weeks prior to registration. Minor surgery ≤ 2 weeks prior to registration.
• Patients who have received investigational drugs ≤ 4 weeks prior to registration and/or registration
• Prior therapy with anti-VEGF targeted agents
• Pleural effusion or ascites that causes respiratory compromise (≥ CTC grade 2 dyspnea)
• QTc > 450 (male) or > 470 (female). Patients with congenital or acquired prolonged QTc syndrome
• Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control.
• Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
• Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
• Unstable angina pectoris
• Symptomatic congestive heart failure
• Myocardial infarction ≤ 6 months prior to registration
• Serious uncontrolled cardiac arrhythmia
• Uncontrolled diabetes
• Severe active or uncontrolled infection
• Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
• Chronic renal disease with documented nephritic or nephrotic syndrome.
• Acute or chronic liver disease
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK222584
• Patients with confirmed diagnosis of human immunodeficiency virus (HIV) infection are excluded at the investigator's discretion if he/she feels that 1) a potential drug interaction between PTK787/ZK 222584 and anti-HIV medications that could influence the efficacy of the anti-HIV medication, or 2) it may place the patient at risk due to the pharmacologic activity of PTK787/ZK 222584.

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• South Carolina Oncology Associates — Columbia, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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