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

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 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

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 ]

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 ]


Enrollment:	104
Study Start Date:	January 2005
Study Completion Date:	June 2011
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Intervention Details:

oral tablet once daily

Other Names:

cediranib
RECENTIN™.

intravenous infusion

Other Name: 5-Fluorouracil, Leucovorin and Oxaliplatin

intravenous infusion

Other Names:

Alimta®
Pemetrexed disodium

intravenous injection

Other Names:

Campto®
Camptosar®
irinotecan hydrochloride

intravenous infusion

Other Name: Taxotere®

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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, see Learn About Clinical Studies.

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

Locations


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

Sponsors and Collaborators

AstraZeneca

Investigators


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

More Information


Responsible Party:	Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00502567 History of Changes
Other Study ID Numbers:	D8480C00008
Study First Received:	July 16, 2007
Last Updated:	July 26, 2011

Keywords provided by AstraZeneca:


advanced solid tumors AZD2171 Phase I

Additional relevant MeSH terms:


Irinotecan Cediranib Cetuximab Pemetrexed Antineoplastic Agents, Phytogenic Antineoplastic Agents Topoisomerase I Inhibitors	Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on June 23, 2017