A Study of PTS for Patients With Solid Tumors

NCT03448211 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: US-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Maximum tolerable dose

  Maximum tolerable dose

  4 weeks post-treatment

Study Arms (1)

Para-toluenesulfonamide Injection (PTS)

EXPERIMENTAL

Investigational product

Drug: Para-toluenesulfonamide Injection (PTS)

Interventions

Para-toluenesulfonamide Injection (PTS) DRUG

Intratumoral injection

Also known as: PTS

Para-toluenesulfonamide Injection (PTS)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PTS International Inc.: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Interventions

4-toluenesulfonamide

Study Officials

• Nan-Shan Zhong

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 28, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: August 1, 2019
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

US (1)