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

Tracking Information

First Received Date ^ICMJE

January 15, 2008

Last Updated Date

January 15, 2010

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00600496 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Non-Randomized
Control:  Dose Comparison
Endpoint Classification:  Safety Study
Intervention Model:  Parallel Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

Breast Cancer
Breast Neoplasms
Colon Cancer
Colonic Cancer
Colon Neoplasms
Lung Cancer
Melanoma
Kidney Cancer

Intervention ^ICMJE

Drug: AZD6244
twice daily oral dose

Other Name: ARRY-142886
Drug: Dacarbazine
intravenous infusion
Drug: Erlotinib
daily oral dose
Drug: Docetaxel
intravenous infusion

Other Name: Taxotere®
Drug: Temsirolimus
intravenous infusion

Study Arms / Comparison Groups

1: Experimental
AZD6244 + docetaxel
Interventions:
- Drug: AZD6244
- Drug: Docetaxel
2: Experimental
AZD6244 + Dacarbazine
Interventions:
- Drug: AZD6244
- Drug: Dacarbazine
3: Experimental
AZD6244 + Erlotinib
Interventions:
- Drug: AZD6244
- Drug: Erlotinib
4: Experimental
AZD6244 + Temsirolimus
Interventions:
- Drug: AZD6244
- Drug: Temsirolimus

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2009

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: AstraZeneca Cancer Locator Service, (US and CA only)

877-400-4656

astrazeneca@emergingmed.com

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00600496

Responsible Party

Rajesh Chopra, MD - Medical Science Director, AstraZeneca

Study ID Numbers ^ICMJE

D1532C00004

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

AstraZeneca

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP