A Study of PTS for Patients With Solid Tumors

NCT ID: NCT03448211

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-08-01

Brief Summary

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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

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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

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Solid Tumor

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Para-toluenesulfonamide Injection (PTS)

Investigational product

Group Type EXPERIMENTAL

Para-toluenesulfonamide Injection (PTS)

Intervention Type DRUG

Intratumoral injection

Interventions

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Para-toluenesulfonamide Injection (PTS)

Intratumoral injection

Intervention Type DRUG

Other Intervention Names

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PTS

Eligibility Criteria

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Inclusion Criteria

* 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.
* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PTS International Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nan-Shan Zhong

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Guangzhou Medical University

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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US-01

Identifier Type: -

Identifier Source: org_study_id

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