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| Sponsor: | Oncothyreon Inc. |
|---|---|
| Information provided by: | Oncothyreon Inc. |
| ClinicalTrials.gov Identifier: | NCT00726583 |
Purpose
This study is being conducted to determine the safety and maximally tolerated dose of PX-866 when given orally on two different schedules: daily on days 1-5 and 8-12 of a 28 day cycle and daily on days 1-28 of a 28 day cycle.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: PX-866 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
| Official Title: | A Phase I Trial of Oral PX-866 (a PI-3K Inhibitor) in Patients With Advanced Solid Tumors |
| Estimated Enrollment: | 90 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Investigational Drug: Experimental
Dose Escalation
|
Drug: PX-866
Oral solution, dose escalation, once per day on days 1 to 5 and 8 to 12 or days 1-28 of a 28 day cycle, until progression or development of unacceptable toxicity
|
PX-866 is a targeted inhibitor of PI-3K. This study is being conducted to determine the maximally tolerated dose of PX-866 when given orally on two different schedules: daily on days 1-5 and 8-12 of a 28 day cycle and daily on days 1-28 of a 28 day cycle.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Colorado | |
| University of Colorado Health Sciences Center | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Sharon Hecker 720-848-0667 sharon.hecker@ucdenver.edu | |
| Principal Investigator: Antonio Jimeno, MD | |
| United States, Texas | |
| M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jonathan Choe 713-794-4443 jmchoe@mdanderson.org | |
| Principal Investigator: Roy Herbst, MD | |
| Sub-Investigator: David Hong, MD | |
More Information
| Responsible Party: | Oncothyreon Inc. ( Larry Romel ) |
| Study ID Numbers: | PX-866-001 |
| Study First Received: | July 30, 2008 |
| Last Updated: | February 3, 2010 |
| ClinicalTrials.gov Identifier: | NCT00726583 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Cancer Solid Tumors Carcinoma |