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PTK787 in Refractory or Relapsed Diffuse Large Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00511043
Recruitment Status : Terminated (Manufacturer stopped drug development)
First Posted : August 3, 2007
Last Update Posted : December 9, 2014
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
David Rizzieri, MD, Duke University

Tracking Information
First Submitted Date  ICMJE August 1, 2007
First Posted Date  ICMJE August 3, 2007
Last Update Posted Date December 9, 2014
Study Start Date  ICMJE November 2005
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2007)
Response [ Time Frame: approximately 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
Safety [ Time Frame: 30 days post last dose of study drug ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2007)
  • Time to progression [ Time Frame: until progression or death ]
  • Safety [ Time Frame: 30 days post last dose of study drug ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PTK787 in Refractory or Relapsed Diffuse Large Cell Lymphoma
Official Title  ICMJE Phase II Open Label Study of PTK787/ZK222584 in Adults Patients With Refractory or Relapsed Diffuse Large Cell Lymphoma
Brief Summary 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.
Detailed Description

In order for tumors to grow and spread to other parts of the body, they need to have a growing blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. In adults, blood vessel cells normally divide very rapidly. It is thought that PTK787/ZK222584 may interfere with the growth of new blood vessels. A drug that interferes with the growth of new blood vessels might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Since normal blood vessel cells divide very rapidly, it might be possible to stop tumor growth without harming normal tissues.

The purpose of this study is to find out if an investigational drug, PTK787/ZK 222584 is safe and effective in treating relapsed or refractory diffuse large cell lymphoma.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, Large-Cell, Diffuse
Intervention  ICMJE Drug: PTK787
PTK787 - 1250mg p.o. daily. Initial dose of 750mg p.o daily starting on day 1 and increased weekly to an intermediate dose of 1000 mg and then a target dose of 1250mg unless a grade ≥ 2 toxicity. Patients 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 patient non-compliance with the protocol requirement.
Other Names:
  • Vatalanib
  • ZK 222584
  • PTK787/ZK 222584
Study Arms  ICMJE Experimental: All pts
PTK787
Intervention: Drug: PTK787
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 6, 2008)
20
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2007)
35
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00511043
Other Study ID Numbers  ICMJE Pro00008648
CPTK787AUS39
7416 ( Other Identifier: Legacy Duke IRB number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Rizzieri, MD, Duke University
Study Sponsor  ICMJE David Rizzieri, MD
Collaborators  ICMJE Novartis Pharmaceuticals
Investigators  ICMJE
Principal Investigator: David A Rizzieri, MD Duke University
PRS Account Duke University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP