Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to test the safety of PRLX 93936 and see what kind of effect it has on patients and their cancer. This study will also determine the highest dose of PRLX 93936 that can be given without causing adverse side effects and the dose of PRLX 93936 that should be used in future studies.
This study will assess the safety, pharmacokinetics, and pharmacodynamics of PRLX 93936 administered intravenously over 1 hr daily for 5 days in patients with advanced solid tumors. Patients will be evaluated prior to dosing, during dosing and following dosing, on a 28-day cycle. Tumor response will be evaluated every other cycle.
Three patients will be assigned per dose level until the Maximum Tolerated Dose (MTD) is reached or a a Dose-Limited Toxicity (DLT) is encountered. Sequential cohorts of three patients will be treated with escalating doses until the Maximum Tolerated Dose (MTD) is reached.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRLX 93936 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRLX 93936 | Drug | PRLX 93936 will be administered intravenously over one hour daily for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical laboratory tests | Weekly | |
| Vital signs | Daily during dosing, then weekly during followup | |
| Electrocardiograms (ECGs) | Multiple times during dosing, then weekly during followup | |
| Echocardiograms (ECHO) | Baseline and every other cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor assessment | Baseline and every other cycle | |
| Blood sampling for pharmacokinetics | Days 1 and 5 of dosing |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Von Hoff, M.D. | TGen Clinical Research Services at Scottsdale Healthcare | Principal Investigator |
| Peter J. Rosen, M.D. | Tower Cancer Research Foundation | Principal Investigator |
| Andrew Wagner, M.D., Ph.D. | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TGen Clinical Research Services at Scottsdale Healthcare | Scottsdale | Arizona | 85258 | United States | ||
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tower Cancer Research Foundation |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |