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This is a Phase 1 safety and dose escalation study to define the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) following IV administration of GPX-150 once every 3 weeks. Escalating doses starting at the dose of 14 mg/m2 and increasing to the dose of 265 mg/m2 will be administered IV once every 3 weeks for up to 8 cycles of treatment. Patients who have previously received an anthracycline are limited to 4 cycles of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GPX-150 for Injection | Experimental | GPX-150 is administered IV on Day 1, followed by a 20 day rest period, every 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GPX-150 for Injection | Drug | Escalating doses starting at the dose of 14 mg/m2 and increasing to the dose of 265 mg/m2 will be administered IV once every 3 weeks for up to 8 cycles of treatment. Patients who have previously received an anthracycline are limited to 4 cycles of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Define maximum tolerated dose and identify dose limiting toxicities following IV administration of GPX-150 for Injection once every 3 weeks | Every 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics and any antitumor activity | Every 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond J Hohl, MD, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | United States |
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| ID | Term |
|---|---|
| C000604876 | 5-imino-13-deoxydoxorubicin |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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