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A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly or Every Two Weeks in Patients With Advanced Solid Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly or Every Two Weeks in Patients With Advanced Solid Malignancies


Inclusion Criteria:



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

- 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 as measured by the Common Terminology Criteria for Adverse Events (CTCAE) grade and type of AEs experienced in the first cycle of treatment.

Outcome Time Frame:

assessed at each treatment

Safety Issue:

No

Principal Investigator

Judith Ochs, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D2782C00001

NCT ID:

NCT00389389

Start Date:

September 2006

Completion Date:

October 2008

Related Keywords:

  • Neoplasms
  • Advanced Solid Malignancies
  • Advanced solid tumors
  • Cancer
  • Phase I
  • Solid tumors
  • Solid malignancies
  • Neoplasms

Name

Location

Research SiteBoulder, Colorado  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas