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

January 29, 2009
September 28, 2012
January 2009
July 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00833326 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
A Study of ARRY-334543 and Docetaxel in Patients With Advanced Cancer
Not Provided

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.

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
    multiple dose, escalating
  • Drug: Docetaxel, mitotic inhibitor; intravenous
    multiple dose, single schedule
  • Drug: Prophylactic growth factors; subcutaneous
    standard of care
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00833326
ARRAY-543-104
No
Array BioPharma
Array BioPharma
Not Provided
Not Provided
Array BioPharma
September 2012

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