A Phase I, Open-Label, Multi-Center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886) - Full Text View

Purpose

This study is being conducted to determine if a combination of AZD6244 given orally twice a day with standard doses of selected chemotherapies will be safe and tolerable for cancer patients with advanced solid tumors. The highest tolerated dose of AZD6244 in combination with selected chemotherapies will be evaluated. The study will also investigate how AZD6244 in combination with standard chemotherapies are absorbed, distributed and excreted by the body as well as the length of time that the drugs remain in the body. Initial and periodic assessments will establish patient response to the combination therapies.

Condition	Intervention	Phase
Breast Cancer Breast Neoplasms Colon Cancer Colonic Cancer Colon Neoplasms Lung Cancer Melanoma Kidney Cancer	Drug: AZD6244 Drug: Dacarbazine Drug: Erlotinib Drug: Docetaxel Drug: Temsirolimus	Phase I

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer Kidney Cancer Lung Cancer Melanoma

Drug Information available for:

Docetaxel Dacarbazine Erlotinib Erlotinib hydrochloride CCI 779 ARRY 142886

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study

Official Title:	A Phase I, Open-Label, Multi-Center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886) When Given in Combination With Standard Doses of Selected Chemotherapies to Patients With Advanced Solid Tumors

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety and tolerability of twice daily oral doses of AZD6244 when administered in combination with standard doses of selected chemotherapies.

Secondary Outcome Measures:

PK of AZD6244 and selected chemotherapies.
Define highest tolerated dose of AZD6244 when in combination with selected chemotherapies.
Tumor response.
Identify factors which may influence the sensitivity to AZD6244 or agents used in combination

Estimated Enrollment:	80
Study Start Date:	December 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZD6244 + docetaxel	Drug: AZD6244 twice daily oral dose Drug: Docetaxel intravenous infusion
2: Experimental AZD6244 + Dacarbazine	Drug: AZD6244 twice daily oral dose Drug: Dacarbazine intravenous infusion
3: Experimental AZD6244 + Erlotinib	Drug: AZD6244 twice daily oral dose Drug: Erlotinib intravenous injection
4: Experimental AZD6244 + Temsirolimus	Drug: AZD6244 twice daily oral dose Drug: Temsirolimus intravenous infusion

Eligibility

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

Criteria

Inclusion Criteria:

Patients will have measurable and/or non-measurable disease, lacking curative options for whom the selected chemotherapy agents represent the standard of care
WHO performance status 0-1
Patients must be able to swallow AZD6244 capsules

Exclusion Criteria:

Prior treatment with a MEK inhibitor
Participation in a clinical study during the last 30 days or have not recovered from side effects of an investigational study drug
Brain metastases or spinal cord compression unless treated and stable (for at least 1 month) off steroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600496

Contacts


Contact: AstraZeneca Clinical Study Information	800-236-9933	information.center@astrazeneca.com

Locations


United States, Michigan
	Research Site	Recruiting
	Detroit, Michigan, United States

United States, Pennsylvania
	Research Site	Recruiting
	Philadelphia, Pennsylvania, United States

United States, Tennessee
	Research Site	Recruiting
	Nashville, Tennessee, United States

Sponsors and Collaborators

AstraZeneca

Investigators


Principal Investigator:	Patricia LoRusso, DO	Karmanos Cancer Institute

Principal Investigator:	Roger Cohen, MD	Fox Chase Cancer Center

Principal Investigator:	Jeffrey Infante, MD	Sarah Cannon Research Institute

More Information

Responsible Party:	AstraZeneca ( Clive Morris, MD - Medical Science Director )
Study ID Numbers:	D1532C00004
First Received:	January 15, 2008
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00600496
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

ARRY-142886

AZD6244

Cancer

Colon Cancer

Breast Cancer

Lung Cancer

Melanoma

Kidney Cancer

Study placed in the following topic categories:

Thoracic Neoplasms

Dacarbazine

Gastrointestinal Diseases

Colonic Diseases

Urogenital Neoplasms

Kidney cancer

Urologic Neoplasms

Melanoma

Docetaxel

Respiratory Tract Diseases

Urologic Diseases

Kidney Neoplasms

Lung Neoplasms

Nevus, Pigmented

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Kidney Diseases

Breast Diseases

Erlotinib

Digestive System Neoplasms

Skin Diseases

Breast Neoplasms

Renal cancer

Intestinal Diseases

Intestinal Neoplasms

Neuroendocrine Tumors

Carcinoma

Neuroectodermal Tumors

Digestive System Diseases

Lung Diseases

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Histologic Type

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Neoplasms, Nerve Tissue

Nevi and Melanomas

Antineoplastic Agents, Alkylating

Alkylating Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00600496