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| Sponsor: | Oncothyreon Inc. |
|---|---|
| Information provided by (Responsible Party): | 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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Investigational Drug
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
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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 | |
| Aurora, Colorado, United States, 80045 | |
| United States, Texas | |
| M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
More Information
| Responsible Party: | Oncothyreon Inc. |
| ClinicalTrials.gov Identifier: | NCT00726583 History of Changes |
| Other Study ID Numbers: | PX-866-001 |
| Study First Received: | July 30, 2008 |
| Last Updated: | October 27, 2011 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
|
Cancer Solid Tumors Carcinoma |
PI-3K PI3 kinase PI3K |
|
Neoplasms |