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The primary objective of this clinical study is as follows:
• To determine the MTD and to assess the safety and tolerability of C31510 administered as a single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors
The secondary objective of this study is as follows:
• To evaluate plasma PK and estimate renal elimination of C31510 administered as a single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors
The exploratory objectives of this study are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 5.62 mg/kg Sterile Compound C31510 for Injection |
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| Cohort 2 | Experimental | 11.25 mg/kg Sterile Compound C31510 for Injection |
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| Cohort 3 | Experimental | 22.5 mg/kg Sterile Compound C31510 for Injection |
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| Cohort 4 | Experimental | 33.0 mg/kg |
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| Cohort 5 | Experimental | 44.0 mg/kg Sterile Compound C31510 for Injection |
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| Cohort 6 | Experimental | 58.7 mg/kg Sterile Compound C31510 for Injection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterile Compound C31510 for Injection | Drug | During the treatment period, subjects in each initial dose level cohort will have a single 4-hour IV infusion of C31510 at the assigned dose level of their particular cohort, three times per week for 26 days (on Day 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26) followed by a 28-day follow up period that will be counted from the first dose given on Day 1. In the absence of unacceptable toxicity or disease progression during the treatment period, those subjects may receive similar 28-day repeat treatment cycles of 3 times per week for up to 1 year, at the discretion of the investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Assessment | Tumors will be assessed by standard methods ex. computerized tomography (CT), MRI etc; at baseline and then once every two treatment cycles of 28 days (2 months) thereafter in the absence of clinical rapid progression of disease. Assessment of tumor vascularity (using DCE-MRI) for at least 6 subjects who received C31510 at the MTD, will be done within 24 hours pre-dose and post-dose. | at baseline and then once every two treatment cycles of 28 days (2 months) thereafter in the absence of clinical rapid progression of disease. |
| Measure | Description | Time Frame |
|---|---|---|
| blood samples taken for plasma pharmacokinetics (PK) evaluation | samples are taken to evaluate plasma pharmacokinetics (PK) and estimate renal elimination of C31510 administered as a single IV infusion in subjects with solid tumors PK will be collected during Day 1 of the first month of each cohort at the following timepoints: pre-dose, post-start of infusion at 0.5, 1, 2, 3.75 (15 min prior to end of infusion), 4.083 (5 min after end of the infusion) 4.5, 6, 8, 10, and 24 hrs. after start of the infusion Additional PK will be done at pre-dose time and at 24 hours post the dose of Day 3, and on Day 28. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarcoma Oncology Center | Santa Monica | California | 90403 | United States |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Cohort 7 | Experimental | 78.2 mg/kg Sterile Compound C31510 for Injection |
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| Cohort 8 | Experimental | 104.3 mg/kg Sterile Compound C31510 for Injection |
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| Cohort 9 | Experimental | 139.0 mg/kg Sterile Compound C31510 for Injection |
|
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| Blood samples collected at pre-dose, post-start of infusion at 0.5, 1, 2, 3.75 (15 min prior to end of infusion), 4.083 (5 min after the end of the infusion) 4.5, 6, 8, 10, and 24 hrs. after the start of the infusion |
| blood samples taken for plasma pharmacodynamics evaluation | blood samples are taken to evaluate the pharmacodynamic correlation of C31510 activity in plasma and peripheral blood cells | Pharmacodynamic blood samples will be collected pre-dose and at 4 and 24 hours post dose after start of the infusion of Day 1 of each treatment cycle. |