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

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

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Kidney Cancer Lung Cancer Melanoma

Drug Information available for: Sirolimus Docetaxel Everolimus CCI 779 Erlotinib hydrochloride Erlotinib ARRY 142886 Dacarbazine

U.S. FDA Resources

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:	March 2011
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 AZD6244 + docetaxel	Drug: AZD6244 twice daily oral dose Other Name: ARRY-142886 Drug: Docetaxel intravenous infusion Other Name: Taxotere®
Experimental: 2 AZD6244 + Dacarbazine	Drug: AZD6244 twice daily oral dose Other Name: ARRY-142886 Drug: Dacarbazine intravenous infusion
Experimental: 3 AZD6244 + Erlotinib	Drug: AZD6244 twice daily oral dose Other Name: ARRY-142886 Drug: Erlotinib daily oral dose
Experimental: 4 AZD6244 + Temsirolimus	Drug: AZD6244 twice daily oral dose Other Name: ARRY-142886 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

Locations

United States, Michigan
Research Site
Detroit, Michigan, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
United States, Texas
Research Site
Houston, Texas, 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
Principal Investigator:	Kevin Kim, MD	M.D. Anderson Cancer Center

More Information

Additional Information:

Cancer Study Locator (US and Canada only) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Rajesh Chopra, MD - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00600496 History of Changes
Other Study ID Numbers:	D1532C00004
Study First Received:	January 15, 2008
Last Updated:	March 31, 2011
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

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Colonic Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Lung Neoplasms
Melanoma
Neoplasms by Site
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases

Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012