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| Sponsor: | Tyrogenex |
|---|---|
| Information provided by (Responsible Party): | Tyrogenex |
| ClinicalTrials.gov Identifier: | NCT01296581 |
Purpose
The purpose of this study is to determine the maximum tolerated dose (MTD) of X-82 as a single agent.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: X-82 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I, First in Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of X-82 in Patients With Advanced Solid Tumors |
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ system function, defined as follows:
Exclusion Criteria:
Contacts and Locations| Contact: Gina Courtney, M.D. | 615-339-4214 | Gina.courtney@scresearch.net |
| United States, Oklahoma | |
| Peggy and Charles Stephens Oklahoma Cancer Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Rachel Higbee 405-271-8777 rachel-higbee@ouhsc.edu | |
| United States, Tennessee | |
| Sarah Cannon Research Institute | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
More Information
| Responsible Party: | Tyrogenex |
| ClinicalTrials.gov Identifier: | NCT01296581 History of Changes |
| Other Study ID Numbers: | X82-CLI-101 |
| Study First Received: | February 14, 2011 |
| Last Updated: | October 11, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Cancer Tumors VEGFR PDGFR |
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Neoplasms |