Solid TumorPhase 1NCT03448211
A Study of PTS for Patients With Solid Tumors
A Phase 1 study testing Para-toluenesulfonamide Injection (PTS) in people with Solid Tumor, run by PTS International Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to determine the MTD of PTS following local and intratumoral injections over a treatment course of two 5-day cycles to patients with palpable advanced solid malignancies who have failed standard treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Para-toluenesulfonamide Injection (PTS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 1 Aug 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
- Subjects are diagnosed as unsuitable for surgical operations or refuse to do so.
- Subject's performance status is classified as Grade 0 to Grade 3. Estimated survival time should be longer than 6 months of time.
- Physical examinations show no serious functional disorders of the heart, liver, kidneys, or blood.
- Subjects were treated with radio or chemotherapy previously. A minimum of 2 to 3 months recovery time is required before treating with this investigational drug.
- Subject is diagnosed as intratracheal lesions with metastasized pulmonary cancer not suitable for surgery, or refuses to be operated.
- Subject should show lobular atelectasis with either complete or incomplete obstruction of the bronchi.
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- Physical examinations should show no functional disorders of the heart, liver, kidneys, central nervous system, and blood.
- Subject performance status to be classified from Grade 0 to Grade 3, who can tolerate the fiberoptic bronchoscopy treatments.
- In-patient is preferred. When subject is in satisfactory conditions, the out Cpatient can also be enrolled in this trial.
- Two to three months recovery time is required for the subject has just received radio or chemotherapy.
- Emergency request, subjects with serious lobular atelectasis and almost complete obstruction of the bronchi.
- With the aid of a tracheal intubation and the help of the respirator, PTS may be intraumorally injected into the obstructed lesion via fiberoptic bronchoscopy outside of the tube, alongside of the intubation.
Who cannot join
- Pregnant women and children will not be used as test subjects.
- Subjects with serious functional disorders of the heart, liver, kidneys, or blood will be excluded.
- Subjects who do not want to participate in the trial will not be used as test subjects.
- Subject does not agree to participate.
- Subject performance status is Grade 4, and the one who does not want to tolerate the discomfort of the PTS treatments via fiberoptic bronchscopy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase I Open-Label, Dose-Escalation Study of Para-toluenesulfonamide Injection (PTS) Administered Intratumorally and Locally to Patients With Solid Tumors
The primary objective of this study is to determine the MTD of PTS following local and intratumoral injections over a treatment course of two 5-day cycles to patients with palpable advanced solid malignancies who have failed standard treatment.
Read the detailed description
The study will be an open, uncontrolled, single-center, phase I study to assess the safety and tolerability of local intra-tumoral injection 2.0ml (660mg), 4.0ml (1220mg), 6.0ml (1880mg) and 8.0ml (2440mg) PTS in female breast cancer patients.
- Conditions
- Solid Tumor
- Being tested
- Para-toluenesulfonamide Injection (PTS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Para-toluenesulfonamide Injection (PTS)Drug
Also called PTS
Intratumoral injection
| Study group | Role | What they receive |
|---|---|---|
| Para-toluenesulfonamide Injection (PTS) | Experimental | Investigational product Receives: Drug: Para-toluenesulfonamide Injection (PTS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerable dose
Maximum tolerable dose
Measured: 4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 May 2018 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Why it stopped: Development strategy reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PTS International Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nan-Shan Zhong, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448211
- Sponsor's protocol ID
- US-01
- Status last verified
- Apr 2018
- First submitted
- 6 Feb 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label, Dose-Escalation Study of Para-toluenesulfonamide Injection (PTS) Administered Intratumorally and Locally to Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT03448211
- Acronym / sponsor ID
- US-01
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Development strategy reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PTS International Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 28 Feb 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.
The primary objective of this study is to determine the MTD of PTS following local and intratumoral injections over a treatment course of two 5-day cycles to patients with palpable advanced solid malignancies who have failed standard treatment.
Detailed description
The study will be an open, uncontrolled, single-center, phase I study to assess the safety and tolerability of local intra-tumoral injection 2.0ml (660mg), 4.0ml (1220mg), 6.0ml (1880mg) and 8.0ml (2440mg) PTS in female breast cancer patients.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Para-toluenesulfonamide Injection (PTS) | Experimental | Drug: Para-toluenesulfonamide Injection (PTS)Investigational product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects are diagnosed as unsuitable for surgical operations or refuse to do so.
- Subject's performance status is classified as Grade 0 to Grade 3. Estimated survival time should be longer than 6 months of time.
- Physical examinations show no serious functional disorders of the heart, liver, kidneys, or blood.
- Subjects were treated with radio or chemotherapy previously. A minimum of 2 to 3 months recovery time is required before treating with this investigational drug.
- Subject is diagnosed as intratracheal lesions with metastasized pulmonary cancer not suitable for surgery, or refuses to be operated.
Key exclusion criteria (5 listed)
- Pregnant women and children will not be used as test subjects.
- Subjects with serious functional disorders of the heart, liver, kidneys, or blood will be excluded.
- Subjects who do not want to participate in the trial will not be used as test subjects.
- Subject does not agree to participate.
- Subject performance status is Grade 4, and the one who does not want to tolerate the discomfort of the PTS treatments via fiberoptic bronchscopy.
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 |
|---|---|---|
| Para-toluenesulfonamide Injection (PTS)Also: PTSIntratumoral injection | Drug | Para-toluenesulfonamide Injection (PTS) |
Primary outcome
Maximum tolerable dose
Time frame: 4 weeks post-treatment
Maximum tolerable dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 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.
Nan-Shan Zhong principal investigator
The First Affiliated Hospital of Guangzhou Medical University
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 Para-toluenesulfonamide Injection (PTS) in people with Solid Tumor, run by PTS International Inc. at 1 site in United States.
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 12 inclusion and 5 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: withdrawn, as of the sponsor's last update on 5 Apr 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Maximum tolerable dose (time frame: 4 weeks post-treatment). 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 5 Apr 2018.