Neoplasms

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Neurofibroma, Plexiform

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Neurofibromatosis

Neurofibromatosis Type 1

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Pirfenidone

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Dusica Babovic-Vuksanovic, M.D.

The study is a phase II, open label trial of oral Pirfenidone in 24 adult patients with neurofibromatosis type 1.

Pirfenidone is a new, broad-spectrum anti-fibrotic drug, with proven in vitro and in vivo negative effects on fibroblast growth and collagen matrix synthesis. Human studies indicate promising therapeutic effects in arresting and reversing fibrosis in a variety of different conditions, where the excessive formation of fibrous tissue is a major pathogenic mechanism. Since the fibrous tissue is a significant component of neurofibroma, reduction of fibrosis could diminish tumor progression and lead to tumor shrinkage. Therefore, Pirfenidone is an excellent candidate for the treatment of plexiform neurofibromas and surgically unresectable tumors in patients with NF1.

Specific aims of this study are:

1. To evaluate efficacy of Pirfenidone in NF1 patients with disfiguring or disabling plexiform neurofibroma (PN) and spinal neurofibromas (SN)
2. To determine the acute, subacute and chronic toxicity of Pirfenidone in patients with NF1.

Clinical Trial of Pirfenidone in Adult Patients With Neurofibromatosis 1

Phase II Clinical Trial of Pirfenidone for the Treatment of Patients With Neurofibromatosis Type I

Mayo Clinic

Respiratory Tract (Lung and Bronchial) Diseases

Wounds and Injuries

Lung Neoplasms

Lung Injury

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Thoracic Injuries

Immune Checkpoint Inhibitors

Pirfenidone: synchronized with RT, 200 mg TID in the first week, 300 mg TID in the second week, and maintenance treatment of 400 mg TID from the third week until 3 months

Radiotherapy: no limitation, TD≥50Gy (BED/ α/β： 10）

200 mg TID in the first week, 300 mg TID in the second week, and maintenance treatment of 400 mg TID from the third week until 3 months

Guang Han, MD,PhD

Guang Han, MD.Phd

Patients with advanced lung cancer who have previously received immunocheckpoint inhibitor therapy, undergone chest radiation therapy again have developed radiation induced lung injury. Pirfenidone has anti-inflammatory and anti fibrosis effects. This study is intended to evaluate the effectiveness of pirfenidone combined with radiotherapy in the prevention of radiation pneumonitis.

Pifenidone Prophylactic Therapy for Radiation Lung Injury in Patients Who Have Previously Received Immune Checkpoint Inhibitors

Pifenidone is Used to Reduce Radiation Lung Injury in Lung Cancer Patients Previously Treated With Immune Checkpoint Inhibitors: A Single-arm, Open-label, Phase II Study

Incidence rate of radiation pneumonia ≥ grade 2 (1 month, 3 month, 6 month)

Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.

DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator

PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator

overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.

Hubei Cancer Hospital

professor

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Calculate from 2 weeks before the start of radiotherapy: week 1: pirfenidone 200mg, tid; week 2: pirfenidone 400mg tid; during radiotherapy: pirfenidone 600mg tid.

Calculate from 2 weeks before the start of radiotherapy: week 1: placebo 200mg, tid; week 2: placebo 400mg tid; during radiotherapy: placebo 600mg tid.

Dose climbing started two weeks before the start of radiotherapy, and the maintenance dose of 600mg bid was reached in the third week until the end of radiotherapy.

Placebo

Jian Guan, M.D.

Yongmei Dai

Yunming Tian

Peibao Lai

Jianda Sun

Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer worldwide, with a 5-year survival rate of less than 50%. Radiotherapy is an important measure to control tumor recurrence. Although radiotherapy has been widely used in patients with head and neck squamous cell carcinoma, the 2-year local recurrence rate of patients with locally advanced disease is still as high as 50%-60%, and the distant metastasis rate is as high as 20%-30%. This is associated with a lower radiosensitivity in HNSCC. Our previous study has confirmed that type I collagen secreted by cancer-associated fibroblasts (CAFs) can enhance the radioresistance of head and neck squamous cell carcinoma. We also confirmed that pirfenidone could reduce type I collagen expression in CAFs and enhance radiosensitivity in vitro and in vivo. Therefore, we plan to translate the basic research into clinical practice and conduct a prospective interventional phase II clinical trial to investigate the safety and efficacy of pirfenidone as a radiosensitizer in HNSCC.

Pirfenidone as a Radiosensitizer in the Treatment of Head and Neck Squamous Cell Carcinoma

Application of Pirfenidone as a Radiosensitizer in the Treatment of Head and Neck Squamous Cell Carcinoma: Phase II Clinical Study

The correlations between ORR, OS and cancer associated fibroblasts, collagen type I, PD-L1 expression in tissues, tumor mutation burden, tumor-related gene changes, plasma cytokines or other biomarkers were explored.

The objective response rate (ORR) is the proportion of patients who achieve a prespecified reduction in tumor volume that is maintained for a minimum duration. The objective response rate was defined as the sum of complete response plus partial response (CR+PR). According to RECIST1.1 criteria, CR was defined as the disappearance of target lesions and the reduction of the short diameter of pathological lymph nodes to less than 10mm. PR: the sum of the measured diameters of the target lesions reduced by 30% compared with the baseline; PD: the sum of the major diameters of all target lesions increased by at least 20%, and the absolute value of the sum of the major diameters increased by more than 5mm, or new lesions appeared. SD: Changes between PR and PD.

OS was defined as the time from the date of inclusion until death from any cause.

treatment-related adverse events will be assessed by CTCAE v5.0

Nanfang Hospital, Southern Medical University

Infections

Pneumonia

Communicable Diseases

Respiratory Tract Infections

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Glucocorticoids

Hormones

Hormone Antagonists

Protective Agents

Antineoplastic Agents, Hormonal

Grade 3-4 checkpoint inhibitor-related pneumonitis

Methylprednisolone 2 mg / kg / d+ pirfenidone (starting from 200mg tid, increasing to 600mg tid within one week and maintaining) . Methylprednisolone was reduced according to the researcher's evaluation of the patient's condition and the specific course of treatment was determined.

Pirfenidone, methylprednisolone

Methylprednisolone 2 mg / kg / d . Methylprednisolone was gradually reduced after the improvement of symptoms and imaging. The treatment course was 6-8 weeks

Chengzhi Zhou, MD

Xinqing Lin, Doctor

Chengzhi Zhou, Professor

Chengzhi Zhou, MA

Checkpoint inhibitor-related pneumonitis (CIP）is a common fatal immune-related adverse event of PD-1/PD-L1 inhibitors. Some CIP patients have poor effect on hormone therapy, and the remission time of CIP varies greatly. Antifibrotic drugs may be effective in patients with CIP.

Pirfenidone can inhibit the occurrence and development of pulmonary fibrosis, reduce pulmonary exudation by inhibiting VEGF and promote pulmonary recovery. In our study, subjects with checkpoint inhibitor-related pneumonitis receive pirfenidone plus methylprednisolone or methylprednisolone.

We randomly divided the patients into two groups and received pirfenidone combined with methylprednisolone or methylprednisolone.

Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of CIP

Clinical Study of Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of Checkpoint Inhibitor-related Pneumonitis

According to CTCAE 4.0 and imaging grade of CIP, the time of reduction by one grade was evaluated.

The number of enrollments reduced by grade 1 in 3 months divided by the total number of enrollments.

Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTCAE 4.0)

Change of Modified Medical Research Council Dyspnea Scale

Beijing Continent Pharmaceutical Co, Ltd.

Zhou Chengzhi

Professor

Carcinoma, Non-Small-Cell Lung

Micronutrients

Hematinics

Vitamins

Paclitaxel

Carboplatin

Pemetrexed

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Arm A Combination Therapy: Pirfenidone combined with standard first-line chemotherapy. Participants will receive the combination of Pirfenidone and carboplatin plus paclitaxel in study treatment cycles that last 21 days. Phase 1 Dose Escalation; followed by Phase 1b Dose Expansion.

Arm B Combination Therapy: Pirfenidone combined with standard first-line chemotherapy. Participants will receive the combination of Pirfenidone and carboplatin plus pemetrexed in study treatment cycles that last 21 days. Phase 1 Dose Escalation; followed by Phase 1b Dose Expansion.

Pirfenidone: 267 mg Capsules by mouth (PO) 3 times per day (TID). Dose Escalation: Level 1:One capsule (total daily dose 801 mg); Level 2: Two capsules (total daily dose 1602 mg); Level 3: Three capsules (total daily dose 2403 mg).

Dose Expansion: Treatment at dose determined by the Phase 1 Dose Escalation.

Area under the curve (AUC) 6 on Day 1 of a 21-day cycle for 4 - 6 cycles.

200 mg/m\^2 on Day 1 of a 21-day cycle for 4 - 6 cycles.

500 mg/m\^2 on Day 1 of a 21-day cycle for 4 - 6 cycles.

Jhanelle Gray, M.D.

The purpose of this study is to find out what effects (good and/or bad) Pirfenidone combined with standard first-line chemotherapy will have on you and non-small cell lung cancer (NSCLC). The investigational drug Pirfenidone is being combined with standard chemotherapy in participants with advanced non-small cell lung cancer. Pirfenidone is approved to treat idiopathic pulmonary fibrosis (IPF) but it isn't currently approved to treat non-small cell lung cancer.

This study will be conducted in two phases: 1) a Phase I dose escalation study with a Standard 3+3 design to determine the recommended Phase II dose and 2) a Phase Ib expansion study to evaluate early signs of efficacy and obtain more toxicity data. The Phase I trial will be a single center, dose-escalation study of pirfenidone combined with standard chemotherapy in the treatment of advanced/metastatic NSCLC, followed by a Phase Ib trial to determine early clinical efficacy \[objective tumor response rate (ORR)\] and toxicity data.

Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC

A Phase I/Ib Trial of Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC

Recommended Phase 1b dose of Pirfenidone in combination with standard first-line chemotherapy, based on Dose Limiting Toxicity (DLT) from phase 1. Dose-limiting Toxicity: The occurrence of any of the following toxicities will be considered a DLT, if judged by the Investigator to be possibly, probably, or definitely related to study drug administration, referring to grade 3-5 adverse events as listed in the protocol document.

ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Complete Response (CR) plus Partial Response (PR). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

PFS according to RECIST 1.1: defined as the time from study registration to progression or death, whichever comes first. PFS for patients last known to be alive and progression free will be censored at the date of last disease assessment. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm).

(Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Overall survival (OS) defined as the time from study registration or death due to any cause. OS for patients last known to be alive will be censored at the date of last contact.

H. Lee Moffitt Cancer Center and Research Institute

Fibrosis

Radiation Fibrosis Syndrome

Radiation Injuries

pirfenidone

Kevin Camphausen, MD

RATIONALE: Pirfenidone may prevent or lessen fibrosis caused by radiation therapy.

PURPOSE: Pilot trial to study the effectiveness of pirfenidone in preventing or lessening fibrosis in patients who have undergone radiation therapy for cancer.

OBJECTIVES:

* Determine the safety and therapeutic efficacy of pirfenidone in cancer patients with radiation-induced fibrosis.

OUTLINE: Patients receive oral pirfenidone 3 times daily. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.

Principal functional abilities are assessed at baseline, every 3 months, and at termination of therapy.

PROJECTED ACCRUAL: A total of 10-25 patients will be accrued for this study within 1 year.

Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer

A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis

National Cancer Institute (NCI)

Precancerous Conditions

Brigitte C. Widemann, MD

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Pirfenidone may slow the growth or prevent further development of plexiform neurofibromas.

PURPOSE: Phase I trial to study the effectiveness of pirfenidone in treating young patients who have neurofibromatosis type 1 and plexiform neurofibroma.

OBJECTIVES:

* Determine the maximum tolerated dose or "comparable dose" of pirfenidone in pediatric patients with neurofibromatosis type 1 and inoperable, symptomatic plexiform neurofibromas.
* Determine the toxic effects of this drug in these patients.
* Determine the plasma pharmacokinetics of this drug in these patients.
* Determine, preliminarily, if this drug could be beneficial for pediatric patients with refractory solid tumors.
* Assess the quality of life of patients treated with this drug.

OUTLINE: This is an open-label, multicenter, dose-escalation study.

Patients receive oral pirfenidone three times daily on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of pirfenidone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Quality of life is assessed at baseline, before course 4, and then after every 6 courses.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 18 months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial of Pirfenidone in Adult Patients With Neurofibromatosis 1	NCT00754780	Neurofibromatos...	Pirfenidone	18 Years - 70 Years	Mayo Clinic
Pifenidone Prophylactic Therapy for Radiation Lung Injury in Patients Who Have Previously Received Immune Checkpoint Inhibitors	NCT05801133	Lung Cancer	Pirfenidone	18 Years -	Hubei Cancer Hospital
Pirfenidone as a Radiosensitizer in the Treatment of Head and Neck Squamous Cell Carcinoma	NCT06142318	Head and Neck S... Radiotherapy Radiosensitizer Pirfenidone	Pirfenidone Placebo	18 Years -	Nanfang Hospital, Southern Medical University
Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of CIP	NCT05280873	Pneumonitis Malignant Tumor	Pirfenidone, me... Methylprednisol...	18 Years - 75 Years	Guangzhou Institute of Respiratory Disease
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC	NCT03177291	Lung Cancer Non Small Cell ... Advanced Cancer Metastatic Lung... Squamous Cell L... Non-Squamous No...	Pirfenidone Carboplatin Paclitaxel Pemetrexed	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer	NCT00020631	Radiation Fibro...	pirfenidone	18 Years -	National Cancer Institute (NCI)
Pirfenidone in Treating Young Patients With Neurofibromatosis Type 1 and Plexiform Neurofibromas	NCT00053937	Neurofibromatos... Precancerous Co...	pirfenidone	3 Years - 21 Years	National Cancer Institute (NCI)
Pifenidone Prophylactic Therapy for Radiation Lung Injury in Patients Who Have Previously Received Immune Checkpoint Inhibitors	NCT05801133	Lung Cancer	Pirfenidone	18 Years -	Hubei Cancer Hospital

Spots Global Cancer Trial Database for pirfenidone

Every month we try and update this database with for pirfenidone cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pirfenidone

Every month we try and update this database with for pirfenidone cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pirfenidone cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.