Trials / Completed
CompletedNCT01606579
Safety and Efficacy Study of PRI-724 in Subjects With Advanced Myeloid Malignancies
An Open-Label, Dose-Escalation Phase I/II Study of PRI-724 for Patients With Advanced Myeloid Malignancies
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Prism Pharma Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
PRI-724 is a new investigational drug being studied to treat subjects with cancer who have advanced myeloid malignancies. PRI-724 is thought to work by blocking the Wnt signaling pathway that cancer cells need to grow and spread (metastasize).
Detailed description
PRI-724 is a new investigational drug being studied to treat subjects with cancer who have advanced myeloid malignancies. PRI-724 is thought to work by blocking the Wnt signaling pathway that cancer cells need to grow and spread (metastasize). Purpose: * To test the safety of PRI-724 when taken intravenously (through the vein). * To observe whether PRI-724 can slow or stop the progression of leukemia. * To find the Maximum Tolerated Dose (highest safe dose) in the first two parts of the study. * To find the dose of PRI-724 that should be used in the third part of the study and possible future clinical trials that will study effectiveness and additional safety. * To test the safety of combining PRI-724 with an approved cancer drug called dasatinib in treating chronic myeloid leukemia (CML). * To evaluate whether the combination of PRI-724 with the approved cancer drug dasatinib slows or stops the progression of chronic myeloid leukemia (CML). * To test the safety of combining PRI-724 with an approved cancer drug called Cytarabine in treating acute myelogenous leukemia (AML). * To evaluate whether the combination of PRI-724 with the approved cancer drug Cytarabine slows or stops the progression of acute myelogenous leukemia (AML). * To measure how much PRI-724 appears and remains in the blood after infusion. * To measure several signals called biomarkers associated with cancer in the blood to see if PRI-724 affects those signals. Study Design: This will be a single center, open-label escalating-dose cohort study with 3 parts: Part I during which the MTD will be determined in acute group patients; Part II during which the MTD will be determined in non-acute group patients; and Part III during which safety and tolerability of escalating doses of PRI-724 will be assessed in combination with dasatinib for CML patients or low dose ara-C therapy for AML patients ≥ 65 years of age.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PRI-724 | PRI-724 |
| DRUG | PRI-724 | PRI-724 in combination with dasatinib |
| DRUG | PRI-724 | PRI-724 in combination with low dose ara-C therapy |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2016-12-30
- Completion
- 2016-12-30
- First posted
- 2012-05-25
- Last updated
- 2017-08-17
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01606579. Inclusion in this directory is not an endorsement.