Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD4877

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: NHL; Lymphoma; Non-Hodgkin Lymphoma

Treatments: Drug: AZD4877

Study type: Interventional

Funder types: Industry

Identifiers

NCT00471367

D2782C00006

Details and patient eligibility

About

This study has two parts (A and B). The primary purpose of Part A is to find the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a twice a week basis. For Part B, an additional 20 patients will be treated at the maximum dose identified in Part A. AZD4877 is an Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)