HPPH Photodynamic Therapy for Patients With Esophageal Cancer

NCT03757754 | Unknown Phase 1

• 1 other identifier: HISUN-HPPH-I-2014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

PHHP; Esophageal cancer; Phase I study

Outcome Measures

Primary Outcomes (1)

• The number of dose-limiting toxicity

  Dose-limiting toxicity would be assesed by CTCAE4.0

  Day 1 to Day 10

Secondary Outcomes (5)

• Maximum observed concentration (Cmax)

  Day 1 to Day 84

• Time to maximum concentration (tmax)

  Day 1 to Day 84

• Apparent terminal elimination phase half (t1/2)

  Day 1 to Day 84

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

  Day 1 to Day 84

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

  Day 1 to Day 84

Study Arms (6)

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.

Drug: HPPH 2.5 mg/m2

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.

Drug: HPPH 3 mg/m2

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.

Drug: HPPH 3.5 mg/m2

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.

Drug: HPPH 4 mg/m2

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.

Drug: HPPH 5 mg/m2

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.

Drug: HPPH 6 mg/m2

Interventions

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.

HPPH 2.5 mg/m2

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 mg/m2

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 3.5 mg/m2

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 4 mg/m2

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 5 mg/m2

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.

HPPH 6 mg/m2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Hisun Pharmaceutical Co. Ltd.: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Huilong Liu, PhD

  General Hospital of Beijing Miitary Command of PLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: open
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiple Ascending Dose, Multiple groups, Multiple centers

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: November 29, 2018
• Study Start: June 3, 2015
• Primary Completion: January 20, 2019
• Study Completion: May 27, 2019
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

CN (1)