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A Phase I Open-label, Multi-center, Dose-escalation and Safety Expansion Study to Assess Safety, Tolerability, and Pharmacokinectics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose of Irinotecan in Patients With Advanced Solid Malignancies.


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors, Cancer, Advanced Solid Malignancies

Thank you

Trial Information

A Phase I Open-label, Multi-center, Dose-escalation and Safety Expansion Study to Assess Safety, Tolerability, and Pharmacokinectics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose of Irinotecan in Patients With Advanced Solid Malignancies.


Inclusion Criteria:



- Advanced solid tumors for which standard treatment doesn't exist or is no longer
effective.

- Must be suitable for treatment with irinotecan

- 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

- Any prior anthracycline treatment

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary objective of this study is to assess the safety and tolerability of AZD7762 alone and in combination with Irinotecan

Outcome Time Frame:

assessed after each course of treatment

Safety Issue:

No

Principal Investigator

Peter Langmuir, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D1040C00004

NCT ID:

NCT00473616

Start Date:

May 2007

Completion Date:

January 2011

Related Keywords:

  • Advanced Solid Tumors
  • Cancer
  • Advanced Solid Malignancies
  • Phase I
  • solid tumors
  • solid malignancies
  • cancer Eligibility
  • Neoplasms

Name

Location
Research Site Beverly, Massachusetts  
Research Site Albany, New York  
Research Site Chattanooga, Tennessee