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A Phase I, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies


Phase 1
20 Years
74 Years
Not Enrolling
Both
Cancer, Solid Tumors, Advanced Solid Malignancies

Thank you

Trial Information

A Phase I, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies


Inclusion Criteria:



- Japanese patients with advanced solid tumors for which standard treatment does not
exist or is no longer effective.

- Must be suitable for treatment with gemcitabine

- Relatively good overall health other than cancer

Exclusion Criteria:

- Poor bone marrow function (not producing enough blood cells).

- Poor liver or kidney function.

- Serious heart conditions

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:

Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram

Outcome Time Frame:

Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2

Safety Issue:

Yes

Principal Investigator

Peter Langmuir, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

D1040C00008

NCT ID:

NCT00937664

Start Date:

July 2009

Completion Date:

February 2011

Related Keywords:

  • Cancer
  • Solid Tumors
  • Advanced Solid Malignancies
  • Phase I
  • cancer
  • solid tumors
  • advanced solid malignancies
  • dose escalation
  • combination treatment
  • CHK inhibitor
  • Japanese
  • Neoplasms

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