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A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a 2 Hour Intravenous Infusion on Two Dose Schedules in Patients With Advanced Solid Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a 2 Hour Intravenous Infusion on Two Dose Schedules in Patients With Advanced Solid Malignancies


Inclusion Criteria:



- Histological or cytological confirmation of a solid, malignant tumour

- At least measurable or non measurable site of disease as defined by modified RECIST
criteria.

Exclusion Criteria:

- Participation in an investigational drug study within 30 days prior to entry or who
have not recovered from the effects of an investigational study drug

- Treatment with radiotherapy/chemotherapy with 4 weeks of first dose

- Recent major surgery within 4 weeks prior to entry to the study

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:

Safety and Tolerability

Outcome Time Frame:

Assessed at each visit

Principal Investigator

Jan Schellens, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NKI

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

D1531C00001

NCT ID:

NCT00497731

Start Date:

May 2005

Completion Date:

April 2009

Related Keywords:

  • Solid Tumors
  • Advanced solid tumors

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