Esophageal Cancer
Conditions
Keywords
PHHP, Esophageal cancer, Phase I study
Brief summary
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.
Detailed description
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.
Interventions
DRUGHPPH 2.5 mg/m2
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.
DRUGHPPH 3 mg/m2
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.
DRUGHPPH 3.5 mg/m2
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.
DRUGHPPH 4 mg/m2
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.
DRUGHPPH 5 mg/m2
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.
DRUGHPPH 6 mg/m2
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.
Sponsors
Zhejiang Hisun Pharmaceutical Co. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
open
Intervention model description
Multiple Ascending Dose, Multiple groups, Multiple centers
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older, Male and female subjects with practicing a highly effective form of birth control, and a signed consent; * Subjects who was diagnosed as Esophageal Cancer or carcinoma of gastric cardia by endoscopy and Biopsy pathology at T1-T3 stage. * Subjects who could not be taken surgery or chemotherapy; with unsucessful surgery or failed chemotherapy; who had refused surgery and chemotherapy * ECOG 0-2, Life expectancy would be more than 3-month
Exclusion criteria
* Subjects were diagnosed as Tracheoesophageal fistula or Esophageal mediatinal fistula, or more than 60 years old with having three kinds of Heart, Lung, Liver and Kidney commorbities; * Hematopoietic WBC \< 3×109/L; HGB \<80g/L; PLT \<80×109/L; PLT \<1.5 times upper limit of normal (ULN) * Hepatic TBIL\>1.5ULN, ALT or AST \>2.5 ULN * Alkaline phosphatase \> 3 times ULN * Uncontrol Hypertension: Bp\>160/100mmHg * Uncomtrol Diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of dose-limiting toxicity | Day 1 to Day 10 | Dose-limiting toxicity would be assesed by CTCAE4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed concentration (Cmax) | Day 1 to Day 84 | PK measurement expressed as Cmax for HPPH |
| Time to maximum concentration (tmax) | Day 1 to Day 84 | PK measurement expressed as Tmax for HPPH |
| Apparent terminal elimination phase half (t1/2) | Day 1 to Day 84 | PK measurement expressed as t1/2 for HPPH |
| Area under the concentration-time curve over the dosing interval (AUC0-t) | Day 1 to Day 84 | PK measurement expressed as AUC0-t for HPPH |
| Area under the concentration-time curve from zero extrapolated to infinity (AUC0-∞) | Day 1 to Day 84 | PK measurement expressed as AUC0-∞ for HPPH |
Countries
China
Outcome results
None listed