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This study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamic effects of a novel anti-cancer drug, EPC2407, administered to patients with advanced cancer which have not responded to or have recurred following treatment with available therapies
This is a Phase I, open label, multicenter, dose-escalation, safety, pharmacokinetic, and pharmacodynamic study of EPC2407 administered intravenously over 60 minutes on a QDx3 schedule repeated every 21 days. Patients are enrolled and dosed at the level defined by the escalation scheme. The primary goal of the study design is to assess toxicity at the fixed dose levels according to the modified Fibonacci schema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPC2407 (crinobulin) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPC2407 (crinobulin) | Drug | IV infusion 1 to 4 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Duration of drug exposure |
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Inclusion Criteria:
Histologically or cytologically confirmed solid tumor or lymphoma,which has progressed on standard therapies, for which effective therapy is not available or for patients who are unwilling to undergo such therapies.
Males and Females at least 18 years of age
Laboratory data as specified below (according to the site's clinical laboratory ranges for normal):
i. Hematology: ANC >1500 cells/mm3, platelet count >100,000 cells/mm3 and Hemoglobin > 9 gm/L ii. Hepatic: Direct bilirubin <1.5 X ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 X ULN. For patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5.0 X ULN iii. Renal: serum creatinine WNL or creatinine clearance >60 mL/min
12-lead electrocardiogram (ECG) QT intervals: QTc ≤ 450 msec for men and ≤ 470 msec for women.
Estimated life expectancy of at least 3 months
ECOG Performance Status < or = 1
Previously treated CNS disease allowed if treatment completed and stable for 4 weeks.
For men and women of child-producing potential - willingness to employ appropriate contraceptive methods (including abstinence) during the study
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments
Cardiac ejection fraction ≥50% by 2D Echocardiogram or > institutional lower limits of normal
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Healthcare | Scottsdale | Arizona | 85258 | United States | ||
| Tower Oncology Research |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000598757 | crolibulin |
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| Beverly Hills |
| California |
| 90211 |
| United States |
| Rebecca and John Moores UCSD Cancer Center | San Diego | California | 92093 | United States |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |