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A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6918 Administered Daily as a Single Agent and in Combination Treatment in Adult Patients With Refractory Solid Malignancies


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

Thank you

Trial Information

A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6918 Administered Daily as a Single Agent and in Combination Treatment in Adult Patients With Refractory Solid Malignancies


Inclusion Criteria:



- Advanced solid tumors for which standard treatment does not exist or is no longer
effective.

- For chemotherapy combination treatment, must be suitable for treatment with either
gemcitabine or pemetrexed.

- 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

- History of uncontrolled epilepsy, Parkinson's disease, Alzheimer's disease, brain
tumor or any uncontrolled psychiatric or nervous system condition

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, Karnofsky performance status

Outcome Time Frame:

Weekly for first two treatment cycles, then every 2-4 weeks

Safety Issue:

Yes

Principal Investigator

Judith Ochs, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D2785C00002

NCT ID:

NCT00733031

Start Date:

August 2008

Completion Date:

March 2009

Related Keywords:

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

Name

Location
Research Site Boulder, Colorado  
Research Site Chattanooga, Tennessee