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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Locations

United States, Colorado
Research Site
Aurora, Colorado, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Judith Ochs, MD	AstraZeneca
Principal Investigator:	Jeffrey Infante, MD	SCRI Development Innovations, LLC
Principal Investigator:	Lia Gore, MD	University of Colorado, Denver

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Judith Ochs, M.D. Medical Science Director, AstraZeneca Pharmaceuticals, LP
ClinicalTrials.gov Identifier:	NCT00733031 History of Changes
Other Study ID Numbers:	D2785C00002
First Posted:	August 12, 2008
Last Update Posted:	December 10, 2010
Last Verified:	December 2010

Keywords provided by AstraZeneca:

Phase I,; cancer,; solid tumors,; advanced solid malignancies,	dose escalation,; combination treatment,; TRK inhibitor

Additional relevant MeSH terms:

Neoplasms; Gemcitabine; Pemetrexed; Antimetabolites, Antineoplastic; Antimetabolites; 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