PTK787 in Refractory or Relapsed Diffuse Large Cell Lymphoma

NCT00511043 | Terminated Phase 2 DMC

• 3 other identifiers: Pro00008648CPTK787AUS397416
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Lymphoma, Large-Cell, Diffuse

Keywords

PTK787; DLCL; Diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Response

  approximately 1 year

Secondary Outcomes (1)

• Safety

  30 days post last dose of study drug

Study Arms (1)

All pts

EXPERIMENTAL

PTK787

Drug: PTK787

Interventions

PTK787 DRUG

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.

Also known as: Vatalanib, ZK 222584, PTK787/ZK 222584

All pts

Eligibility Criteria

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

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

Sponsors & Collaborators

• David Rizzieri, MD: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (3)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

South Carolina Oncology Associates

Columbia, North Carolina, 29210, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

vatalanib

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• David A Rizzieri, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine, Division of Cellular Therapy

Study Record Dates

• First Submitted: August 1, 2007
• First Posted: August 3, 2007
• Study Start: November 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: June 1, 2010
• Last Updated: December 9, 2014

Record last verified: 2014-11

Locations

US (3)