Esophageal CancerPhase 1HPPHNCT03757754
HPPH Photodynamic Therapy for Patients With Esophageal Cancer
A Phase 1 study testing HPPH 2.5 mg/m2, HPPH 3 mg/m2 and HPPH 3.5 mg/m2 in people with Esophageal Cancer, run by Zhejiang Hisun Pharmaceutical Co. Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- HPPH 2.5 mg/m2, HPPH 3 mg/m2 and HPPH 3.5 mg/m2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2015to 27 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Oncology, General Hospital of Beijing Miitary Command of PLA
Beijing, Beijing Municipality, 100010
About this study
Official title: Evalution of Safety, Tolerability and Pharmacokinetics of of HPPH in Ascending Dose for Cancer Patients in Phase I Clinical Trial
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.
Read the 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.
- Conditions
- Esophageal Cancer
- Being tested
- HPPH 2.5 mg/m2, HPPH 3 mg/m2, HPPH 3.5 mg/m2, HPPH 4 mg/m2, HPPH 5 mg/m2
- Keywords
- PHHP, Esophageal cancer, Phase I study
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPPH 2.5 mg/m2Drug
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/m2Drug
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/m2Drug
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/m2Drug
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/m2Drug
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/m2Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: HPPH 6 mg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of dose-limiting toxicity
Dose-limiting toxicity would be assesed by CTCAE4.0
Measured: Day 1 to Day 10
Secondary outcomes (5)
Maximum observed concentration (Cmax)
PK measurement expressed as Cmax for HPPH
Measured: Day 1 to Day 84
Time to maximum concentration (tmax)
PK measurement expressed as Tmax for HPPH
Measured: Day 1 to Day 84
Apparent terminal elimination phase half (t1/2)
PK measurement expressed as t1/2 for HPPH
Measured: 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
Measured: Day 1 to Day 84
Area under the concentration-time curve from zero extrapolated to infinity (AUC0-∞)
PK measurement expressed as AUC0-∞ for HPPH
Measured: Day 1 to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start3 Jun 2015
- Primary completion20 Jan 2019 (estimated)
- Study completion27 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Multiple Ascending Dose, Multiple groups, Multiple centers
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huilong Liu, PhD, Principal investigator, General Hospital of Beijing Miitary Command of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757754
- Sponsor's protocol ID
- HISUN-HPPH-I-2014
- Acronym
- HPPH
- Status last verified
- Nov 2018
- First submitted
- 22 Oct 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evalution of Safety, Tolerability and Pharmacokinetics of of HPPH in Ascending Dose for Cancer Patients in Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT03757754
- Acronym / sponsor ID
- HPPH / HISUN-HPPH-I-2014
- Conditions
- Esophageal Cancer
- Keywords
- PHHP, Esophageal cancer, Phase I study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2015 (actual)
- Primary completion
- 20 Jan 2019 (estimated)
- Study completion
- 27 May 2019 (estimated)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Multiple Ascending Dose, Multiple groups, Multiple centers
| Arm | Type | Receives |
|---|---|---|
| HPPH 2.5 mg/m2 | Experimental | Drug: HPPH 2.5 mg/m2HPPH 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 | Experimental | Drug: HPPH 3 mg/m2HPPH 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 | Drug: HPPH 3.5 mg/m2HPPH 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 | Drug: HPPH 4 mg/m2HPPH 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 | Drug: HPPH 5 mg/m2HPPH 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 | Experimental | Drug: HPPH 6 mg/m2HPPH 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPPH 2.5 mg/m2HPPH 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. | Drug | HPPH 2.5 mg/m2 |
| HPPH 3 mg/m2HPPH 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. | Drug | HPPH 3 mg/m2 |
| HPPH 3.5 mg/m2HPPH 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. | Drug | HPPH 3.5 mg/m2 |
| HPPH 4 mg/m2HPPH 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. | Drug | HPPH 4 mg/m2 |
| HPPH 5 mg/m2HPPH 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. | Drug | HPPH 5 mg/m2 |
| HPPH 6 mg/m2HPPH 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. | Drug | HPPH 6 mg/m2 |
Primary outcome
The number of dose-limiting toxicity
Time frame: Day 1 to Day 10
Dose-limiting toxicity would be assesed by CTCAE4.0
5 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Day 1 to Day 84
Time to maximum concentration (tmax)
Time frame: Day 1 to Day 84
Apparent terminal elimination phase half (t1/2)
Time frame: Day 1 to Day 84
Area under the concentration-time curve over the dosing interval (AUC0-t)
Time frame: Day 1 to Day 84
Area under the concentration-time curve from zero extrapolated to infinity (AUC0-∞)
Time frame: Day 1 to Day 84
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huilong Liu, PhD principal investigator
General Hospital of Beijing Miitary Command of PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HPPH 2.5 mg/m2, HPPH 3 mg/m2 and HPPH 3.5 mg/m2 in people with Esophageal Cancer, run by Zhejiang Hisun Pharmaceutical Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of dose-limiting toxicity (time frame: Day 1 to Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.