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Business Decision
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To evaluate the safety and tolerability of ART-123 in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab
To compare the safety and tolerability of ART-123 to placebo in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lowest Dose | Experimental | Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab) |
|
| Low Dose | Experimental | Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)" |
|
| Medium Dose | Experimental | Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)" |
|
| High Dose | Experimental | Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)" |
|
| Highest Dose | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thrombomodulin alfa | Drug | Weight based dose of reconstituted treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) | Number and percentage of participants experiencing one or more adverse events which occurred or worsened in severity after the start of the first dose of investigational medicinal product (IMP) | From start of first IMP dose (Cycle 1, Day 1) through End of Treatment (EOT) visit; planned for 6 weeks |
| Number and Percentage of Participants with Serious TEAEs | Number and percentage of participants experiencing one or more serious adverse events which occurred or worsened in severity after the start of the first dose of IMP | From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks |
| Number and Percentage of Participants with TEAEs Leading to Death | Number and percentage of participants with TEAEs that resulted in death | From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks |
| Number and Percentage of Participants with TEAEs Leading to IMP Discontinuation | Number and percentage of participants with TEAEs that lead to discontinuation of IMP | From start of first IMP dose (Cycle 1, Day 1) through planned third IMP dose; planned for 4 weeks |
| Number and Percentage of Participants with Bleeding Events | Number and percentage of participants experiencing bleeding events | From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks |
| Number and Percentage of Participants with Serious Bleeding Events | Number and percentage of participants with bleeding events that represent serious adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of Thrombomodulin | Plasma concentrations of thrombomodulin associated with Cycle 1 dosing (each cycle is 14 days) | Cycle 1, Day 1 (each cycle is 14 days) |
| Plasma Concentrations of 5-fluorouracil (5-FU) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Libbie McKenzie, MD FASN | Veloxis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills Cancer Center | Beverly Hills | California | 90210 | United States | ||
| UCLA Dept. of Medicine - Hematology/Oncology |
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Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
|
| Placebo | Placebo Comparator | Lyophilized placebo reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)" |
|
|
| Placebo | Drug | Weight based dose of reconstituted treatment |
|
| From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks |
| Number and Percentage of Participants with Dose Limiting Toxicity (DLT) | Number and percentage of participants experiencing DLT | From start of first IMP dose (Cycle 1, Day 1) until the start of the third IMP dose; planned for 4 weeks |
| Number and Percentage of Participants with Abnormal Complete Blood Count (CBC) Results | Descriptive statistics will summarize the following by cohort: red blood cell count, hemoglobin, hematocrit, white blood cell count, white blood cell differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), and platelet count | 6 weeks |
| Number and Percentage of Participants with Abnormal Serum Chemistry Results | Descriptive statistics will summarize the following by cohort: aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, lactate dehydrogenase, total bilirubin, total protein, albumin, blood urea nitrogen, creatinine, glucose, and electrolytes (sodium, potassium, chloride) | 6 weeks |
| Number and Percentage of Participants with Abnormal Coagulation Panel Results | Descriptive statistics will summarize the following by cohort: international normalized ratio (INR), activated partial thromboplastin time (APTT) | 6 weeks |
| Number and Percentage of Participants with Abnormal Qualitative Urinalysis Results | Qualitative summary of the following by cohort: protein, glucose, and occult blood | 6 weeks |
| Number and Percentage of Participants with Abnormal Vital Signs | Descriptive statistics will summarize the following by cohort: body temperature, pulse, and blood pressure | 6 weeks |
| Number and Percentage of Participants with Anti-ART-123 Antibodies | Number and Percentage of Participants with detectable anti-ART-123 antibodies; samples testing positive for anti-ART-123 antibodies will be tested for the presence of neutralizing antibodies | 6 weeks |
Plasma concentrations of 5-FU associated with Cycle 1 dosing (each cycle is 14 days)
| Cycle 1, Day 1 (each cycle is 14 days) |
| Plasma Concentrations of Oxaliplatin | Plasma concentrations of oxaliplatin associated with Cycle 1 and Cycle 3 dosing (each cycle is 14 days) | Cycle 1, Day 1 and Cycle 3, Day 1 (each cycle is 14 days) |
| Serum Concentrations of Bevacizumab | Serum concentrations of bevacizumab associated with Cycle 1 and Cycle 3 dosing (each cycle is 14 days) | Cycle 1, Day 1 and Cycle 3, Day 1 (each cycle is 14 days) |
| Los Angeles |
| California |
| 90095 |
| United States |
| Eastern Connecticut Hematology & Oncology Associates | Norwich | Connecticut | 06360 | United States |
| Mid-Florida Hematology & Oncology Centers | Orange City | Florida | 32763 | United States |
| Horizon Oncology Research, Inc. | Lafayette | Indiana | 47905 | United States |
| American Oncology Partners, P.A. | Bethesda | Maryland | 20817 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| St. Vincent Frontier Cancer Center | Billings | Montana | 59101 | United States |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | United States |
| Site #115 | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Prisma Health Cancer Institute | Greenville | South Carolina | 29605 | United States |
| Nashville Oncology Associates, PC | Nashville | Tennessee | 37203 | United States |
| Site #120 | Dallas | Texas | 75230 | United States |
| Site #114 | Houston | Texas | 77024 | United States |
| MultiCare Regional Cancer Center | Tacoma | Washington | 98405 | United States |
| Yokohama City University Medical Center | Yokohama | Kanagawa | 232-0024 | Japan |
| Kurashiki Central Hospital | Kurashiki-shi | Okyama | 710-8602 | Japan |
| NHO Kyushu Cancer Center | Fukuoka | Japan |
| Gifu University Hospital | Gifu | Japan |
| Kagawa University Hospital | Kita-gun | Japan |
| Kitakyushubyoin Kitakyusyu General Hospital | Kitakyushu-shi | Japan |
| Kumpukai Sano Hospital | Kobe | Japan |
| NHO Shikoku Cancer Center | Matsuyama | Japan |
| Kochi Medical School Hospital | Nankoku-shi | Japan |
| NHO Osaka National Hospital | Osaka | Japan |
| Osaka General Medical Center | Osaka | Japan |
| Tonan Hospital | Sapporo | Japan |
| Shizuoka Cancer Center | Sunto-gun | Japan |
| University of Tsukuba Hospital | Tsukuba | Japan |
| ID | Term |
|---|---|
| C472045 | ART123 |
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