A Study of PTS for Patients With Solid Tumors

PTS International Inc.

Status and phase: Withdrawn; Phase 1

Conditions: Solid Tumor

Treatments: Drug: Para-toluenesulfonamide Injection (PTS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03448211

US-01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

Para-toluenesulfonamide Injection (PTS)

Experimental group

Description:

Investigational product

Treatment:

Drug: Para-toluenesulfonamide Injection (PTS)