PTK787 in Refractory or Relapsed Diffuse Large Cell Lymphoma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00511043
• Date of registration: 01/08/2007
• Primary sponsor: David Rizzieri
• Public title: PTK787 in Refractory or Relapsed Diffuse Large Cell Lymphoma
• Scientific title: Phase II Open Label Study of PTK787/ZK222584 in Adults Patients With Refractory or Relapsed Diffuse Large Cell Lymphoma
• Date of first enrolment: November 2005
• Target sample size: 20
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00511043
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: David A Rizzieri, MD
• Affiliation: Duke University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

- Patients who are taking therapeutic warfarin sodium (Coumadin) or similar oral
anticoagulants that are metabolized by the cytochrome P450 system.

- Patients unwilling to or unable to comply with the protocol

- Other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration or may interfere with the interpretation of study results and in
the judgment of the investigator would make the patient inappropriate for entry into
this study.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphoma, Large-Cell, Diffuse

Intervention(s)

Drug: PTK787

Primary Outcome(s)

Response [Time Frame: approximately 1 year]

Secondary Outcome(s)

Safety [Time Frame: 30 days post last dose of study drug]

Secondary ID(s)

CPTK787AUS39

Pro00008648 (7416)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis Pharmaceuticals