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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00833326
Recruitment Status : Completed
First Posted : February 2, 2009
Last Update Posted : October 1, 2012
Sponsor:
Information provided by (Responsible Party):
Array BioPharma

Tracking Information
First Submitted Date  ICMJE January 29, 2009
First Posted Date  ICMJE February 2, 2009
Last Update Posted Date October 1, 2012
Study Start Date  ICMJE January 2009
Actual 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 ]
  • 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 ]
  • Characterize the pharmacokinetics (PK) of study drug and docetaxel. [ Time Frame: Duration of study ]
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 ]
  • To assess the safety of ARRY-334543 in combination with docetaxel [ Time Frame: 10 months ]
  • To assess the pharmacokinetic parameters of ARRY-334543 and docetaxel [ Time Frame: 10 months ]
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 ]
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE 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
Actual Enrollment  ICMJE
 (submitted: April 11, 2011)
27
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2009)
30
Actual Study Completion Date  ICMJE July 2010
Actual 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00833326
Other Study ID Numbers  ICMJE ARRAY-543-104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Array BioPharma
Study Sponsor  ICMJE Array BioPharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Array BioPharma
Verification Date September 2012

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