A Study of ARRY-334543 in Patients With Advanced Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Array BioPharma

ClinicalTrials.gov Identifier:

NCT00637702

First received: March 12, 2008

Last updated: February 15, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	March 12, 2008
Last Updated Date	February 15, 2013
Start Date ^ICMJE	February 2008
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 28, 2012)	Characterize the safety profile of the new formulation of study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ] Establish the maximum tolerated dose (MTD) of the new formulation of study drug. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ] Characterize the pharmacokinetics (PK) of the new formulation of study drug (in terms of plasma concentrations) when administered in a fed versus fasted state. [ Time Frame: Day 1 and Day 8 ] [ Designated as safety issue: No ] Assess the exposure of the new formulation of study drug in terms of plasma concentrations. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: March 12, 2008)	Safety and Tolerability of ARRY-334543 Tablets [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ] Determination of the maximum tolerated dose [ Time Frame: Cycle 1 ] [ Designated as safety issue: No ] Determination of the effect of food on the plasma pharmacokinetics of the ARRY-334543 tablet formulation [ Time Frame: Duration ] [ Designated as safety issue: No ] Determination of the plasma pharmacokinetics [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00637702 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 28, 2012)	Assess the efficacy of the new formulation of study drug in terms of tumor dimension assessment. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: March 12, 2008)	Preliminary assessment of efficacy [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of ARRY-334543 in Patients With Advanced Cancer
Official Title ^ICMJE	Not Provided
Brief Summary	This is a Phase 1 study during which patients with advanced solid tumors will receive a new formulation of investigational study drug ARRY-334543. Patients will receive increasing doses of study drug in order to achieve the highest dose possible that will not cause unacceptable side effects. The patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. In addition, the effect of food on the new formulation will be evaluated. Approximately 24 patients from Canada will be enrolled in this study (Active, not recruiting).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Advanced Cancer
Intervention ^ICMJE	Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral single dose and multiple dose, escalating
Study Arm (s)	Experimental: ARRY-334543 Intervention: Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	31
Completion Date	October 2012
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Key Inclusion Criteria: Histological or cytological evidence of malignancy. Patients with advanced solid tumors who are no longer candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy. Cardiac ejection fraction ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition (MUGA). Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2. Additional criteria exist. Key Exclusion Criteria: Uncontrolled brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days). Use of an investigational medication or device within 30 days prior to first dose of study drug. Major surgery within 30 days prior to first dose of study drug. Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites). Active, uncontrolled infection requiring systemic antibiotic therapy or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment. Pregnancy or lactation. Known positive serology for the human immunodeficiency virus (HIV), 'active' hepatitis B and/or hepatitis C. Additional criteria exist.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT00637702
Other Study ID Numbers ^ICMJE	ARRAY-543-103
Has Data Monitoring Committee	Not Provided
Responsible Party	Array BioPharma
Study Sponsor ^ICMJE	Array BioPharma
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Array BioPharma
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top