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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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NHL, Lymphoma, Non-Hodgkin Lymphoma

Intervention / Treatment
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* Drug: AZD4877


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD4877|intravenous infusion administered twice a week for 2 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, AZD4877, Lymphoma, B-cell non-Hodgkin lymphoma