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

March 12, 2008
February 15, 2013
February 2008
October 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00637702 on ClinicalTrials.gov Archive Site
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 ]
Preliminary assessment of efficacy [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of ARRY-334543 in Patients With Advanced Cancer
Not Provided

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).

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Cancer
Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral
single dose and multiple dose, escalating
Experimental: ARRY-334543
Intervention: Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00637702
ARRAY-543-103
Not Provided
Array BioPharma
Array BioPharma
Not Provided
Not Provided
Array BioPharma
February 2013

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