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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003950-25 | EudraCT Number |
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| Name | Class |
|---|---|
| Threshold Pharmaceuticals | INDUSTRY |
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This is an open-label, Phase 1, two-center trial to evaluate the mass balance and metabolite profile of carbon 14 [14C]-labeled TH-302 (Label 1 and Label 2) followed by subsequent treatment with unlabeled TH-302 in cancer subjects with locally advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C] TH-302 (Label 1) | Experimental |
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| [14C] TH-302 (Label 2) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] TH-302 (Label 1) | Drug | [14C]-labeled TH-302 (Label 1) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics profile in plasma: Cmax, Tmax, AUC (0-t), lambda_z, t1/2, AUC (0-infinity), CL, Vss, Vz, MRT for TH-302 and its active metabolite Br-IPM | Days 1 and 8 of Cycle 1 | |
| Pharmacokinetics profile in excreta: Cumulative Ae (0-t), Ae (0-infinity), percent radioactive dose excreted in urine and feces, AeUF, CLR, CLNR for TH-302 and its active metabolite Br-IPM | Day 1 of Cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Treatment-emergent adverse events (TEAEs) | Baseline up to Day 30 after the last dose of study treatment | |
| Blood to plasma ratio of total 14C-radioactivity | Days 1 and 8 of Cycle 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please contact the Merck KGaA Communication Center located in | Darmstadt | Germany |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 25, 2017 | |
| Reset | Jul 12, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 25, 2017 | Jul 12, 2018 |
| ID | Term |
|---|---|
| C552526 | TH 302 |
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| [14C] TH-302 (Label 2) | Drug | [14C]-labeled TH-302 (Label 2) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A. |
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| Unlabeled TH-302 | Drug | Unlabeled TH-302 will be administered along with labeled TH-302 at the dose of 340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Day 1 of Part A, followed by recommended Phase 2 dose (RP2D) of 480 mg/m^2 as monotherapy infusion over 30 minutes on Days 8 and 15 of Part A; and on Days 1, 8 and 15 of Part B, until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow up, or death. |
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| Total and free plasma concentrations of TH-302 in plasma | Day 1 of Cycle 1 |
| Number of subjects with tumor response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) | Tumor response was defined as the occurrence of complete response (CR) or partial response (PR) based on the investigator's assessment according to RECIST v 1.1. | Up to 1 year |
| Unbound fraction (fu) of TH-302 in plasma | Day 1 of Cycle 1 |