Full Text View
Tabular View
No Study Results Posted
Related Studies
A Phase I, Open-Label, Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ARRY-380 Given on a Daily Oral Regimen in Subjects With Advanced Cancer
This study is currently recruiting participants.
Verified by Array BioPharma, January 2009
First Received: March 31, 2008   Last Updated: January 8, 2009   History of Changes
Sponsored by: Array BioPharma
Information provided by: Array BioPharma
ClinicalTrials.gov Identifier: NCT00650572
  Purpose

The purpose of this Phase I study is to assess the safety and tolerability of ARRY-380 in patients with advanced solid malignancies who have failed at least one previous standard therapy and who are no longer candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy, and to determine the maximum tolerated dose as defined by significant dose limiting toxicity.


Condition Intervention Phase
Cancer
Drug: ARRY-380
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title: A Phase I, Open-Label, Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ARRY-380 Given on a Daily Oral Regimen in Subjects With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Assessment of safety and tolerability of ARRY-380 in patients with advanced solid malignancies. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Determination of maximum tolerated dose as defined by significant dose limiting toxicity. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the expression of ErbB2 and other relevant pathway genes in archival tumor tissue, to evaluate the amplification of relevant pathway genes (such as ErbB2) in tumor tissue. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ARRY-380: Experimental Drug: ARRY-380
Drug in capsule

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological evidence of one of the following malignancies: breast, colorectal, prostate, lung, ovarian, endometrial, bladder, salivary gland or other cancer which the Investigator and Sponsor believe may express the ErbB2 target.
  • Subjects with advanced solid tumors that have failed at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
  • Subjects with ErbB2 positive breast cancer and with clinical indication for trastuzumab or lapatinib should have received prior therapy with trastuzumab and lapatinib (if available) or declined the treatment option of trastuzumab and lapatinib prior to entry into the study.
  • Subject has an ECOG performance status between 0-2 (Part A) and between 0-1 (Part B)
  • Measurable disease (at least 1 target lesion) according to modified RECIST (Part B Only)

Exclusion Criteria:

  • Subject has uncontrolled or symptomatic brain metastases (If a subject 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 of initiating study therapy.
  • Major surgery within 30 days prior to first dose.
  • Radiotherapy or chemotherapy within 28 days prior to first dose (not including palliative radiotherapy at focal sites).
  • Pregnancy or lactation.
  • Known positive for HIV, Hepatitis B and/or Hepatitis C
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650572

Locations
United States, Texas
The University of Texas, MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77230
Contact: Alicia Thierry     713-745-6787     athierry@mdanderson.org    
Principal Investigator: Stacy Moulder, M.D.            
Canada, British Columbia
British Columbia Cancer Agency Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Christina Chandra     604-877-6098 ext 2806     CChandra@bccancer.bc.ca    
Principal Investigator: Stephen Chia, M.D.            
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: Tracie Hanna     613-544-2631 ext 6641     tracie.hanna@krcc.on.ca    
Principal Investigator: Tara Baetz, M.D.            
Sponsors and Collaborators
Array BioPharma
  More Information

No publications provided

Responsible Party: Array BioPharma Inc. ( Julie Kang, Clinical Program Manager )
Study ID Numbers: ARRAY-380-101
Study First Received: March 31, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00650572     History of Changes
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

ClinicalTrials.gov processed this record on September 11, 2009