HPPH Photodynamic Therapy for Patients With Esophageal Cancer

Esophageal Cancer Clinical Trial

— HPPH  

Official title:

Evalution of Safety, Tolerability and Pharmacokinetics of of HPPH in Ascending Dose for Cancer Patients in Phase I Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03757754
• Other study ID #: HISUN-HPPH-I-2014
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 3, 2015
• Est. completion date: May 27, 2019

Study information

• Verified date: November 2018
• Source: Zhejiang Hisun Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 27, 2019
• Est. primary completion date: January 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• HPPH 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.
• HPPH 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.
• HPPH 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.
• HPPH 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.
• HPPH 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.
• HPPH 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.

Locations

Country	Name	City	State
China	Department of Oncology, General Hospital of Beijing Miitary Command of PLA	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Hisun Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of dose-limiting toxicity	Dose-limiting toxicity would be assesed by CTCAE4.0	Day 1 to Day 10
Secondary	Maximum observed concentration (Cmax)	PK measurement expressed as Cmax for HPPH	Day 1 to Day 84
Secondary	Time to maximum concentration (tmax)	PK measurement expressed as Tmax for HPPH	Day 1 to Day 84
Secondary	Apparent terminal elimination phase half (t1/2)	PK measurement expressed as t1/2 for HPPH	Day 1 to Day 84
Secondary	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
Secondary	Area under the concentration-time curve from zero extrapolated to infinity (AUC0-8)	PK measurement expressed as AUC0-8 for HPPH	Day 1 to Day 84