A Study to Assess Safety, Tolerability and PK of AZD2171 and Chemotherapy on Patients With Solid Tumors - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00502567

Purpose

A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of AZD2171 when administered with various anticancer regimens (part A) and to confirm the tolerability of its combination with FOLFOX (part B).

Condition	Intervention	Phase
Advanced Solid Tumor	Drug: AZD2171 Drug: FOLFOX Drug: Pemetrexed Drug: Irinotecan (administered with & without Cetuximab) Drug: Docetaxel	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1, Open Label Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2171 and Selected Chemotherapy Regimens When Given in Combination to Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Irinotecan U 101440E Docetaxel Irinotecan hydrochloride Pemetrexed Pemetrexed disodium Cetuximab Cediranib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Determine the safety and tolerability of once daily oral doses of AZD2171 when given in combination with one of these anticancer regimens; FOLFOX, Pemetrexed, Irinotecan, Docetaxel [ Time Frame: After 5 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Examine the PK interaction of AZD2171 with one of the 4 different chemotherapeutic regimens. Make a preliminary evaluation of clinical response as measured by objective response rate. [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ]

Enrollment:	104
Study Start Date:	January 2005
Estimated Study Completion Date:	January 2010

Intervention Details:

oral tablet once daily

intravenous infusion

intravenous injection

intravenous infusion

Eligibility

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

Criteria

Inclusion Criteria:

histologically confirmed metastatic cancer that is not amenable to surgery or radiation therapy with curative intent
measurable lesion by CT or other techniques according to RECIST

Exclusion Criteria:

Inadequate bone marrow reserve
history of poorly controlled hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502567

Locations

United States, Michigan
Research Site
Detroit, Michigan, United States
Research Site
Ann Arbor, Michigan, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Jane Robertson	AstraZeneca
Study Chair:	Marcello Marotti, MD	AstraZeneca
Principal Investigator:	Patricia LoRusso, DO	Wayne State University

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	D8480C00008
Study First Received:	July 16, 2007
Last Updated:	September 8, 2009
ClinicalTrials.gov Identifier:	NCT00502567 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

advanced solid tumors
AZD2171
Phase I

Study placed in the following topic categories:

Antimetabolites
Irinotecan
Cetuximab
Leucovorin
Folate
Folic Acid Antagonists
Folinic Acid

Vitamin B9
Docetaxel
Pemetrexed
Folic Acid
Oxaliplatin
Fluorouracil
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Antimetabolites
Pemetrexed
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Irinotecan
Enzyme Inhibitors
Folic Acid Antagonists
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009