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Phase I study was to investigate the safety and tolerability of the photosensitizer (PS) 2-[1-hexyloxyethyl]-2-devinyl pyropheophorbide-a (HPPH) for injection in patients with Esophageal Cancer. It was to characterize the pharmacokinetics of HPPH and efficacy of HPPH.
The present study is phase I study to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending injection doses of HPPH in Patients with Esophageal Cancer. Up to 30 patients are planned to be enrolled in 6 cohorts with each cohort consisting of 3-6 patients ( male and/or female patients). In each cohort, patients will receive HPPH and Lyophilized treatment. The dose escalation in Cohorts was from 2.5 to 3, 3.5, 4, 5, and 6mg/m2 of HPPH, respectively, administered intravenous drop infusion over 1 hour, once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPPH 2.5 mg/m2 | Experimental | HPPH 2.5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH. |
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| HPPH 3 mg/m2 | Experimental | HPPH 3 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH. |
|
| HPPH 3.5 mg/m2 | Experimental | HPPH 3.5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH. |
|
| HPPH 4 mg/m2 | Experimental | HPPH 4 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH. |
|
| HPPH 5 mg/m2 | Experimental | HPPH 5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPPH 2.5 mg/m2 | Drug | HPPH was administered as a single, 2.5 mg/m2, slow intravenous infusion over 1 hour , and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of dose-limiting toxicity | Dose-limiting toxicity would be assesed by CTCAE4.0 | Day 1 to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | PK measurement expressed as Cmax for HPPH | Day 1 to Day 84 |
| Time to maximum concentration (tmax) | PK measurement expressed as Tmax for HPPH |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huilong Liu, PhD | General Hospital of Beijing Miitary Command of PLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, General Hospital of Beijing Miitary Command of PLA | Beijing | Beijing Municipality | 100010 | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C083998 | 2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a |
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Multiple Ascending Dose, Multiple groups, Multiple centers
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open
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| HPPH 6 mg/m2 | Experimental | HPPH 6 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH. |
|
| HPPH 3 mg/m2 | Drug | HPPH was administered as a single, 3 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH. |
|
| HPPH 3.5 mg/m2 | Drug | HPPH was administered as a single, 3.5 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH. |
|
| HPPH 4 mg/m2 | Drug | HPPH was administered as a single, 4 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH. |
|
| HPPH 5 mg/m2 | Drug | HPPH was administered as a single, 5 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH. |
|
| HPPH 6 mg/m2 | Drug | HPPH was administered as a single, 6 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH. |
|
| Day 1 to Day 84 |
| Apparent terminal elimination phase half (t1/2) | PK measurement expressed as t1/2 for HPPH | Day 1 to Day 84 |
| Area under the concentration-time curve over the dosing interval (AUC0-t) | PK measurement expressed as AUC0-t for HPPH | Day 1 to Day 84 |
| Area under the concentration-time curve from zero extrapolated to infinity (AUC0-∞) | PK measurement expressed as AUC0-∞ for HPPH | Day 1 to Day 84 |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |