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A Phase I Open Label Multi Center Dose Escalation Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose Gemcitabine 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 Center Dose Escalation Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose Gemcitabine in Patients With Advanced Solid Malignancies


Inclusion Criteria:



- Histologically or cytologically confirmed malignancy that is metastatic or
unresectable and for which standard curative or palliative measures do not exist or
are no longer effective

- ECOG performance status of 0 or 1

- Patient and tumor type must be suitable for treatment with weekly standard
gemcitabine.

Exclusion Criteria:

- Inadequate bone marrow reserve, inadequate liver function or impaired renal function

- Any troponin elevation (above normal range)

- Stage II, III, or IV cardiac status, according to New York Heart Association (NYHA)
classification; recent history (ie, within 6 months) of coronary artery disease or
arteriosclerotic cardiovascular disease (angina, myocardial infarction [MI])

- 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:

To assess the safety and tolerability of AZD7762 alone and in combination with Gemcitabine

Outcome Time Frame:

Assessed after each course of treatment

Safety Issue:

No

Principal Investigator

Peter Langmuir, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D1040C00002

NCT ID:

NCT00413686

Start Date:

December 2006

Completion Date:

May 2010

Related Keywords:

  • Solid Tumors
  • Mixed solid tumors

Name

Location

Research SiteBaltimore, Maryland  
Research SiteBattle Kreek, Michigan