A Study of ARRY-334543 and Docetaxel in Patients With Advanced Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Array BioPharma

ClinicalTrials.gov Identifier:

NCT00833326

First received: January 29, 2009

Last updated: September 28, 2012

Last verified: September 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 29, 2009
Last Updated Date	September 28, 2012
Start Date ^ICMJE	January 2009
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 28, 2012)	Establish the maximum tolerated dose (MTD) of study drug in combination with docetaxel. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ] Characterize the safety profile of study drug in combination with docetaxel in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ] Characterize the pharmacokinetics (PK) of study drug and docetaxel. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: January 30, 2009)	To determine the maximum tolerated dose (MTD) of ARRY-334543 when combined with docetaxel [ Time Frame: 10 months ] [ Designated as safety issue: No ] To assess the safety of ARRY-334543 in combination with docetaxel [ Time Frame: 10 months ] [ Designated as safety issue: Yes ] To assess the pharmacokinetic parameters of ARRY-334543 and docetaxel [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00833326 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 28, 2012)	Assess the efficacy of the study drug in combination with docetaxel in terms of tumor response. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: January 30, 2009)	To assess the preliminary efficacy of ARRY-334543 in combination with docetaxel in regards to tumor response [ Time Frame: 10 months ] [ 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 and Docetaxel in Patients With Advanced Cancer
Official Title ^ICMJE	Not Provided
Brief Summary	This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and docetaxel (with prophylactic growth factor support). Patients will receive increasing doses of study drug in combination with docetaxel in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in this study.
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 multiple dose, escalating Drug: Docetaxel, mitotic inhibitor; intravenous multiple dose, single schedule Drug: Prophylactic growth factors; subcutaneous standard of care
Study Arm (s)	Experimental: ARRY-334543 + docetaxel + prophylactic growth factors Interventions: Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral Drug: Docetaxel, mitotic inhibitor; intravenous Drug: Prophylactic growth factors; subcutaneous
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	27
Completion Date	July 2010
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Key Inclusion Criteria: Histologically or cytologically confirmed diagnosis of any advanced/metastatic solid tumor suitable for treatment with docetaxel. Tumor recurred or progressed following at least one line of chemotherapy, except if no standard of care exists or if the patient refuses standard of care treatment. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2. Must be able to take and retain oral medications. Other criteria exist. Key Exclusion Criteria: Active concomitant malignancies. Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days prior to study start). Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C. Requiring intravenous (IV) alimentation. Pregnancy or lactation. Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug. Anti-ErbB1 and/or ErbB2 targeted therapy or anticancer hormonal therapy within 14 days prior to first dose of study drug. History of hypersensitivity to or intolerance of docetaxel. Other 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	United States

Administrative Information
NCT Number ^ICMJE	NCT00833326
Other Study ID Numbers ^ICMJE	ARRAY-543-104
Has Data Monitoring Committee	No
Responsible Party	Array BioPharma
Study Sponsor ^ICMJE	Array BioPharma
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Array BioPharma
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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