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A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Twice a Week in Adult Patients With Advanced Solid Malignancies Including Lymphoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, NHL, Non-Hodgkin Lymphoma

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Trial Information

A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Twice a Week in Adult Patients With Advanced Solid Malignancies Including Lymphoma


Inclusion Criteria:



- Part A: Advanced solid tumors (including lymphoma without bone marrow involvement)
for which standard treatment doesn't exist or is no longer effective.

- Part B: B-cell non-Hodgkin lymphoma that is not eligible for curative therapy or has
relapsed.

- Relatively good overall health other than your cancer

Exclusion Criteria:

- Poor bone marrow function (not producing enough blood cells). Serious heart
conditions. Poor liver or kidney function

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To identify a maximum tolerated dose of AZD4877 by assessment of the incidence of dose limiting toxicities

Outcome Time Frame:

on a twice a week schedule for two weeks out of every three weeks

Safety Issue:

No

Principal Investigator

Jeffrey Skolnik, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D2782C00006

NCT ID:

NCT00471367

Start Date:

April 2007

Completion Date:

December 2008

Related Keywords:

  • Lymphoma
  • NHL
  • Non-Hodgkin Lymphoma
  • Phase I
  • AZD4877
  • Lymphoma
  • B-cell non-Hodgkin lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Research SiteAlbany, New York  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina