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Sponsored by: |
Array BioPharma |
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Information provided by: | Array BioPharma |
ClinicalTrials.gov Identifier: | NCT00650572 |
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 |
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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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. |
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 |