Investigational Agent AG-013736 In Combinations With Standard Of Care Treatments For Patient's With Advanced Solid Tumor - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00454649

Purpose

To determine the best dose of this investigational agent AG-013736 in combination with various standard of care treatments for advanced solid tumors.

Condition	Intervention	Phase
Neoplasms	Drug: AG-013736 + chemotherapy combination	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 1 Dose-Finding Study Of The Anti-Angiogenesis Agent, AG-013736, In Combinations Of Paclitaxel/Carboplatin, Weekly Paclitaxel, Docetaxel, Capecitabine, Gemcitabine/Cisplatin and Pemetrexed/Cisplatin In Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Paclitaxel Axitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Determine maximally tolerated dose of AG-013736 in combination with various chemotherapeutic regimens. [ Time Frame: 4.5 yrs ] [ Designated as safety issue: Yes ]
To determine the overall safety and tolerability of Carboplatin/Paclitaxel and Axitinib in patients with squamous-cell Non-Small Cell Lung Cancer (NSCLC). [ Time Frame: 4.5 yrs ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate pharmacokinetic (PK) parameters of AG-013736 and chemotherapy regimens [ Time Frame: 4.5 yrs ] [ Designated as safety issue: Yes ]
Determine preliminary efficacy via objective response rate [ Time Frame: 4.5 yrs ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	December 2005
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: AG-013736 + chemotherapy combination the following separate groups were included: axitinib plus carboplatin plus paclitaxel in three different schedules plus paclitaxel weekly plus docetaxel plus capecitabine plus gemcitabine/cisplatin plus pemetrexed/cisplatin

Eligibility

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

Criteria

Inclusion Criteria:

Advanced solid tumors suitable for treatment with Taxanes, with or without carboplatin, or treatment with Capecitabine, Gemcitabine/Cisplatin. or Pemetrexed/Cisplatin

Exclusion Criteria:

Tumors abutting or providing support for blood vessels
Any significant gastrointestinal abnormalities or active bleeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454649

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

United States, Georgia
Pfizer Investigational Site	Recruiting
Augusta, Georgia, United States, 30912
United States, Illinois
Pfizer Investigational Site	Active, not recruiting
Harvey, Illinois, United States, 60426
Pfizer Investigational Site	Active, not recruiting
Harvey, Illinois, United States, 60426-4265
Pfizer Investigational Site	Active, not recruiting
Tinley Park, Illinois, United States, 60477
United States, Indiana
Pfizer Investigational Site	Active, not recruiting
Hobart, Indiana, United States, 46342
Pfizer Investigational Site	Active, not recruiting
Munster, Indiana, United States, 46321
United States, Pennsylvania
Pfizer Investigational Site	Active, not recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Pfizer Investigational Site	Active, not recruiting
Houston, Texas, United States, 77030-4009
United States, Washington
Pfizer Investigational Site	Completed
Kennewick, Washington, United States, 99336
Poland
Pfizer Investigational Site	Active, not recruiting
Warszawa, Poland, 02-781
Spain
Pfizer Investigational Site	Completed
BARCELONA, Spain, 08003
Pfizer Investigational Site	Recruiting
MADRID, Spain, 28046

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4061019
Study First Received:	March 29, 2007
Last Updated:	September 8, 2009
ClinicalTrials.gov Identifier:	NCT00454649 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

axitinib, chemotherapy, anti-angiogenesis, VEGF inhibition

Study placed in the following topic categories:

Pemetrexed
Docetaxel
Signs and Symptoms
Capecitabine
Cisplatin
Paclitaxel

Tubulin Modulators
Antimitotic Agents
Carboplatin
Gemcitabine
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors

Additional relevant MeSH terms:

Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Paclitaxel
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009