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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00471367

Enrollment

Registered

2007-05-09

Start date

2007-04-30

Completion date

2008-12-31

Last updated

2009-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, NHL, Non-Hodgkin Lymphoma

Keywords

Phase I, AZD4877, Lymphoma, B-cell non-Hodgkin lymphoma

Brief summary

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

Interventions

DRUGAZD4877

intravenous infusion administered twice a week for 2 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
To identify a maximum tolerated dose of AZD4877 by assessment of the incidence of dose limiting toxicities	on a twice a week schedule for two weeks out of every three weeks

Secondary

Measure	Time frame
To evaluate the safety and tolerability of AZD4877 by assessment of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE) grade and type of AE, changes in laboratory values, vital signs, and incidence of protocol defined dose modification	assessed after each course of treatment
Dose Expansion (Part B):Estimate efficacy of AZD4877 through evaluation of objective response rate, progression-free survival and disease control rate in patients with B-cell non-Hodgkin lymphoma using the revised response criteria for malignant lymphoma	Assessed during treatment and post treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026