Phase I Single Ascending Dose/Multiple Ascending Dose in Patients Treated With AZD7762 and Irinotecan - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00473616

Purpose

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug Irinotecan based on the side effects experienced by patients that receive both drugs

Condition	Intervention	Phase
Advanced Solid Tumors Cancer Advanced Solid Malignancies	Drug: AZD7762 Drug: Irinotecan	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	A Phase I, Open-Label, Multi-Centre, Dose Escalation Study to Assess Safety, Tolerability and PK of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose Irinotecan in Patients With Advanced Solid Malignancies.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary objective of this study is to assess the safety and tolerability of AZD7762 alone and in combination with Irinotecan [ Time Frame: assessed after each course of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762. [ Time Frame: assessed after each course of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	May 2007
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZD7762 monotherapy followed by AZD7762 + irinotecan	Drug: AZD7762 intravenous infusion Drug: Irinotecan intravenous injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Advanced solid tumors for which standard treatment doesn't exist or is no longer effective.
Must be suitable for treatment with irinotecan
Relatively good overall health other than your cancer

Exclusion Criteria:

Poor bone marrow function (not producing enough blood cells)
Serious heart conditions
Poor liver or kidney function
Any prior anthracycline treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473616

Contacts

Contact: AstraZeneca Cancer Study Locator Service	877-400-4656	astrazeneca@emergingmed.com
Contact: AstraZeneca Information (Outside, US)	001-800-236-9933

Locations

United States, Massachusetts
Research Site	Recruiting
Boston, Massachusetts, United States
United States, New York
Research Site	Recruiting
New York, New York, United States
United States, Tennessee
Research site	Recruiting
Nashville, Tennessee, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Judith Ochs, MD

AstraZeneca

More Information

Additional Information:

US and Canada only This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	D1040C00004
Study First Received:	May 14, 2007
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00473616 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Phase I
solid tumors
solid malignancies
cancer Eligibility

Study placed in the following topic categories:

Irinotecan
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Irinotecan
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009