A Study of PTS for Patients With Solid Tumors

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.

Study Overview

• Status: Withdrawn
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Para-toluenesulfonamide Injection (PTS)

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 Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Para-toluenesulfonamide Injection (PTS); Investigational product	Drug: Para-toluenesulfonamide Injection (PTS); Intratumoral injection; Other Names: PTS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tolerable dose	Maximum tolerable dose	4 weeks post-treatment

Collaborators and Investigators

• Sponsor: PTS International Inc.
• Investigators: Principal Investigator: Nan-Shan Zhong, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: US-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No