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HPPH Photodynamic Therapy for Patients With Esophageal Cancer (HPPH)

Primary Purpose

Esophageal Cancer

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

HPPH 2.5 mg/m2

HPPH 3 mg/m2

HPPH 3.5 mg/m2

HPPH 4 mg/m2

HPPH 5 mg/m2

HPPH 6 mg/m2

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring PHHP, Esophageal cancer, Phase I study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Oncology, General Hospital of Beijing Miitary Command of PLA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

HPPH 2.5 mg/m2

HPPH 3 mg/m2

HPPH 3.5 mg/m2

HPPH 4 mg/m2

HPPH 5 mg/m2

HPPH 6 mg/m2

Arm Description

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.

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, 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, 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, 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 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.

Outcomes

Primary Outcome Measures

The number of dose-limiting toxicity

Dose-limiting toxicity would be assesed by CTCAE4.0

Secondary Outcome Measures

Maximum observed concentration (Cmax)

PK measurement expressed as Cmax for HPPH

Time to maximum concentration (tmax)

PK measurement expressed as Tmax for HPPH

Apparent terminal elimination phase half (t1/2)

PK measurement expressed as t1/2 for HPPH

Area under the concentration-time curve over the dosing interval (AUC0-t)

PK measurement expressed as AUC0-t for HPPH

Area under the concentration-time curve from zero extrapolated to infinity (AUC0-∞)

PK measurement expressed as AUC0-∞ for HPPH

Full Information

NCT ID

NCT03757754

First Posted

October 22, 2018

Last Updated

November 27, 2018

Sponsor

Zhejiang Hisun Pharmaceutical Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03757754

Brief Title

HPPH Photodynamic Therapy for Patients With Esophageal Cancer

Acronym

HPPH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 3, 2015 (Actual)

Primary Completion Date

January 20, 2019 (Anticipated)

Study Completion Date

May 27, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Hisun Pharmaceutical Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

Keywords

PHHP, Esophageal cancer, Phase I study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

Multiple Ascending Dose, Multiple groups, Multiple centers

Masking

None (Open Label)

Masking Description

open

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HPPH 2.5 mg/m2

Arm Type

Experimental

Arm Description

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.

Arm Title

HPPH 3 mg/m2

Arm Type

Experimental

Arm Description

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.

Arm Title

HPPH 3.5 mg/m2

Arm Type

Experimental

Arm Description

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.

Arm Title

HPPH 4 mg/m2

Arm Type

Experimental

Arm Description

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.

Arm Title

HPPH 5 mg/m2

Arm Type

Experimental

Arm Description

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.

Arm Title

HPPH 6 mg/m2

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

HPPH 2.5 mg/m2

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

HPPH 3 mg/m2

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

HPPH 3.5 mg/m2

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

HPPH 4 mg/m2

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

HPPH 5 mg/m2

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

HPPH 6 mg/m2

Intervention Description

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.

Primary Outcome Measure Information:

Title

The number of dose-limiting toxicity

Description

Dose-limiting toxicity would be assesed by CTCAE4.0

Time Frame

Day 1 to Day 10

Secondary Outcome Measure Information:

Title

Maximum observed concentration (Cmax)

Description

PK measurement expressed as Cmax for HPPH

Time Frame

Day 1 to Day 84

Title

Time to maximum concentration (tmax)

Description

PK measurement expressed as Tmax for HPPH

Time Frame

Day 1 to Day 84

Title

Apparent terminal elimination phase half (t1/2)

Description

PK measurement expressed as t1/2 for HPPH

Time Frame

Day 1 to Day 84

Title

Area under the concentration-time curve over the dosing interval (AUC0-t)

Description

PK measurement expressed as AUC0-t for HPPH

Time Frame

Day 1 to Day 84

Title

Area under the concentration-time curve from zero extrapolated to infinity (AUC0-∞)

Description

PK measurement expressed as AUC0-∞ for HPPH

Time Frame

Day 1 to Day 84

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huilong Liu, PhD

Organizational Affiliation

General Hospital of Beijing Miitary Command of PLA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Oncology, General Hospital of Beijing Miitary Command of PLA

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100010

Country

China

12. IPD Sharing Statement

Learn more about this trial

HPPH Photodynamic Therapy for Patients With Esophageal Cancer

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