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

This study has been terminated.

(PK results demonstrate low and variable plasma concentrations so that achieving therapeutic concentrations is unlikely.)

Sponsor:

ClinicalTrials.gov Identifier:

NCT00733031

First Posted: August 12, 2008

Last Update Posted: December 10, 2010

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.

Information provided by:

AstraZeneca

Purpose

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	Intervention	Phase
Cancer, Solid Tumors Advanced Solid Malignancies	Drug: AZD6918 Drug: gemcitabine Drug: pemetrexed	Phase 1


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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:

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 ]


Estimated Enrollment:	75
Study Start Date:	August 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Information from the National Library of Medicine

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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

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 ClinicalTrials.gov identifier (NCT number): NCT00733031

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


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 Submitted:	August 8, 2008
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

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