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Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00733031
Recruitment Status : Terminated (PK results demonstrate low and variable plasma concentrations so that achieving therapeutic concentrations is unlikely.)
First Posted : August 12, 2008
Last Update Posted : December 10, 2010
Information provided by:

Brief Summary:
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.

Condition or disease Intervention/treatment Phase
Cancer, Solid Tumors Advanced Solid Malignancies Drug: AZD6918 Drug: gemcitabine Drug: pemetrexed Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: gemcitabine
gemcitabine administered in combination with AZD6918
Drug: gemcitabine
intravenous, doses are on an intermittent schedule
Other Name: Gemzar

Experimental: pemetrexed
pemetrexed administered in combination with AZD6918
Drug: pemetrexed
intravenous, dose administered every 21-days
Other Name: Alimta

Experimental: AZD6918
AZD6918 administered alone
Drug: AZD6918
liquid suspension, daily, oral dose

Primary Outcome Measures :
  1. Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, Karnofsky performance status [ Time Frame: Weekly for first two treatment cycles, then every 2-4 weeks ]

Secondary Outcome Measures :
  1. Pharmacokinetic effect of AZD6918 when administered alone and in combination with chemotherapy [ Time Frame: According to protocol specified schedule, the number of PK samples collected during Cycle 1 (up to 28 days) based on treatment with AZD6918 alone or in combination with chemotherapy ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00733031

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United States, Colorado
Research Site
Aurora, Colorado, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
Sponsors and Collaborators
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Study Director: Judith Ochs, MD AstraZeneca
Principal Investigator: Jeffrey Infante, MD SCRI Development Innovations, LLC
Principal Investigator: Lia Gore, MD University of Colorado, Denver
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Responsible Party: Judith Ochs, M.D. Medical Science Director, AstraZeneca Pharmaceuticals, LP Identifier: NCT00733031    
Other Study ID Numbers: D2785C00002
First Posted: August 12, 2008    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: December 2010
Keywords provided by AstraZeneca:
Phase I,
solid tumors,
advanced solid malignancies,
dose escalation,
combination treatment,
TRK inhibitor
Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors