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.

ClinicalTrials.gov 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

Sponsor:

Information provided by:

AstraZeneca

Study Description

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

Layout table for study information

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

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Arms and Interventions

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

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 ]

Eligibility Criteria

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.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

Layout table for location information

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

Sponsors and Collaborators

AstraZeneca

Investigators

Layout table for investigator information

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

Layout table for additonal information

Responsible Party:	Judith Ochs, M.D. Medical Science Director, AstraZeneca Pharmaceuticals, LP
ClinicalTrials.gov 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, cancer, solid tumors, advanced solid malignancies,	dose escalation, combination treatment, TRK inhibitor

Additional relevant MeSH terms:

Layout table for 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

To Top