Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

After 15 consecutive days of takeing 100mg Umorestat capsule of each participant, 2 mL of peripheral venous blood is collected at 3 h, 8 h and 24 h (D16) on the 15th day into the vacuum blood collection tube via EDTA anticoagulation for genotyping and metabolite determination.

After 15 consecutive days of takeing 200mg Umorestat capsule of each participant, 2 mL of peripheral venous blood is collected at 3 h, 8 h and 24 h (D16) on the 15th day into the vacuum blood collection tube via EDTA anticoagulation for genotyping and metabolite determination.

After 15 consecutive days of takeing 400mg Umorestat capsule of each participant, 2 mL of peripheral venous blood is collected at 3 h, 8 h and 24 h (D16) on the 15th day into the vacuum blood collection tube via EDTA anticoagulation for genotyping and metabolite determination.

After 15 consecutive days of takeing 600mg Umorestat capsule of each participant, 2 mL of peripheral venous blood is collected at 3 h, 8 h and 24 h (D16) on the 15th day into the vacuum blood collection tube via EDTA anticoagulation for genotyping and metabolite determination.

Genotyping is performed using the subjects' blood cells

Genotyping

Herui Yao

Herui Yao, PhD

Yunfang Yu, MD

Based on the tolerability, safety and pharmacokinetics phase I/II clinical trials of ulimostat hydrochloride capsules (LH011) combined with gemcitabine hydrochloride (GEM) in locally advanced/metastatic pancreatic cancer patients, to determine pharmacokinetics, the biotransformation pathway and metabolite profile of ulimostat in patients with locally advanced/metastatic pancreatic cancer.

This study is a research on the pharmacokinetics and gene polymorphisms of ulimostat hydrochloride capsules in patients with locally advanced/metastatic pancreatic cancer. Aims to collect the "Phase I/II clinical trials of the tolerability, safety and pharmacokinetics of ulimostat capsules (LH011) combined with gemcitabine hydrochloride (GEM) in patients with locally advanced/metastatic pancreatic cancer" patient's peripheral blood sample to determine the structure of the metabolites of ulimostat in the biological samples and trough concentration and genotyping tests were performed on patients to investigate the correlation between gene polymorphisms of metabolic enzymes, transporters, target protein uPA and proteins expressed in upstream and downstream signaling pathways and blood drug concentration, efficacy, safety and tolerance of ulimostat.

This experiment involves genotyping of blood cells。

Study on Umorestat Hydrogen Sulfate Capsule in Patients With Locally Advanced/Metastatic Pancreatic Cancer

Study on Pharmacokinetics and Gene Polymorphism of Umorestat Hydrogen Sulfate Capsule in Patients With Locally Advanced/Metastatic Pancreatic Cancer

Determine the drug metabolite profile: Serum samples were detected by ultra-high pergormance liquid tandem chromatography quadrupole time of flight mass spectrometry(LC-MS). Differential metabolites were screened by principal component analysis(PCA), orthogonal projections to latent structures-discriminant analysis(OPLS-DA) and Student's t-test. Then the hierarchical clustering analysis(HCA) was carried out for the screened differential metabolites.

To determine the relationship between genotyping and drug exposure, efficacy and safety: Employs PCR to amplify the regions of the genome containing each SNP, then use MassARRAY to detect mass differences between fragments differing by a single base. Use genotyping test results to do correlation analysis with drug concentration, safety results, and efficacy results to determine the relationship between different types of gene locus mutations and drug concentration, efficacy, and adverse reactions.

Sun Yat-sen University

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Androgens

Prednisone

Satraplatin

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

satraplatin - 80 mg/m\^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days

80 mg/m\^2 days 1-5 of every 35 day cycle

prednisone

William L Dahut, M.D.

Background:

Satraplatin is an experimental drug that may be of benefit to patients with prostate cancer.

Prednisone is approved for treating prostate cancer.

The gene excision repair cross-complementing rodent repair deficiency complementation group 1 (ERCC1) helps repair cell damage caused by satraplatin. It is possible that patients who have a variant of this gene will not benefit from treatment with satraplatin because the drug will not be able to damage the cancer cells effectively.

Objectives:

To determine if satraplatin may help treat prostate cancer in patients with certain variants of the ERCC1 gene.

Eligibility:

Patients with advanced androgen-independent prostate cancer whose disease has not responded to hormonal therapy or at least one type of chemotherapy and whose x-rays, scans or other tests have shown their cancer to be spreading.

Design:

Participants have a blood test to determine if they have a variant of the ERCC1 gene.

Participants take satraplatin by mouth every day for 5 consecutive days out of every 35 days and prednisone by mouth every day. These 35-day treatment cycles may continue for 6 months or longer, depending on the benefits and side effects of the treatment.

During the treatment period, patients undergo the following tests and procedures:

* Blood tests on days 1 of the treatment cycle.
* Weekly blood draws for the first 3 treatment cycles.
* Imaging studies (e.g., bone scans, computed tomography (CT) scans) every two cycles to determine the response to treatment.
* Surgical or medical suppression of testosterone in patients whose cancer cells continue to grow due to exposure to the hormone....

Background:

* Satraplatin is an oral, third-generation platinum analog that has recently been shown to increase prostatic specific antigen (PSA) decline rates and progression-free survival in hormone-resistant prostate cancer.
* Satraplatin acts by binding to deoxyribonucleic acid (DNA) forming intra- and interstrand cross links (DNA adducts), resulting in cell-cycle arrest in G2 phase and eventual apoptosis. One of the mechanisms that bring about resistance to platinum-based chemotherapy is removal of the platinum-DNA adducts by DNA repair pathways, called nucleotide excision repair (NER) and base excision repair (BER) pathways.
* Polymorphisms in the DNA repair genes causing impaired NER and BER capability has recently been shown in some cancers, including head and neck squamous cell carcinoma, non-small cell lung carcinoma, and ovarian carcinoma to predict better treatment outcome and response to platinum treatment.

Objectives:

* Primary objective of this single arm study is to determine if the presence of ERCC1 variant gene polymorphism which is involved with DNA damage repair may be associated with an impact on the progression-free survival of patients with metastatic prostate cancer.
* Secondary objectives of this study includes demonstration of biologic effect by the drug satraplatin in the patient and in the tumor whenever possible, by obtaining tissue biopsy and white blood cell collections, to determine correlation of biologic or clinical effects with PSA progression, evaluate correlations between genotype expression, repair pathways and clinical events, and obtain laboratory correlates which will include pharmacogenetic analysis of prostate cancer patients with genotyping using Polymerase chain reaction (PCR) followed by either restriction fragment length polymorphism or direct sequencing to genotype single nucleotide polymorphisms of ERCC1, x-ray repair cross-complementing protein 1 (XRCC1), and poly (ADP-ribose) polymerase 1 (PARP1).

Eligibility:

* Patients with metastatic androgen-independent prostate cancer.
* Had docetaxel-based chemotherapy, but no more than 1 previous cytotoxic chemotherapy line.
* Good organ function.

Design:

* Phase II trial with single stage design and a planned accrual of 66 patients.
* Progression-free survival will be determined using a Fisher's exact test.
* Will treat all enrolled patients with oral satraplatin 80 mg/m\^2 dose on days 1-5 of every 35-days cycle plus Prednisone 5 mg twice daily every 35 days.
* Genotyping will be performed after the first 20 patients to determine if the proportion for wild-type ERCC1 and variants follow a 20:80 split.

Satraplatin and Prednisone to Treat Prostate Cancer

A Phase II Study of Satraplatin and Prednisone in Metastatic Androgen Independent Prostate Cancer (AIPC)

Time between the start of therapy and progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive Disease is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Overall Survival is the time between the first day of treatment to the day of death.

National Cancer Institute (NCI)

Principal investigator

The time frame for adverse events includes one year follow-up data.

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. William Dahut

24 pts were enrolled but only 21/24 were assessed for OS. One pt died on treatment and (e.g.3 pts were non-evaluable for analysis of response).

Progression Free Survival.

Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)

Median Overall Survival (OS)

Overall Study

Behaviors and Mental Disorders

Colorectal Neoplasms

Alcohol Drinking

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Drinking Behavior

Anti-Infective Agents

Central Nervous System Depressants

Ethanol

Histologically confirmed colorectal adenocarcinoma

without the diagnosis of CRC and accompanied the patient to the primary care clinic visit

Yen-Hui CHEN

According to the statistic reports from World Health Organization (WHO) International Agency for Research on Cancer (IARC), the incidence and mortality rate of colorectal cancer ranked third and fourth respectively among ten most commonly diagnosed cancer worldwide; moreover, based on the statistics from Health Promotion Administration, Ministry of Health and Welfare in Taiwan, the incidence and mortality rate of colorectal cancer ranked second and third respectively among call cancer in Taiwanese population. However, if colorectal cancer is diagnosed and treated in early phase, the 5-year survival rate for stage I colorectal cancer can be up to 90%; on the other hand, the 5-year survival rate for end stage colorectal cancer is only approximately 10%. Therefore, the screening, early diagnosis od colorectal cancer is crucial. To date, there are some known risk factors for colorectal cancer, including familial adenomatous polyposis, obesity, physical inactivity, etc. Alcohol had also been identified as an important risk factor for colorectal cancer, and the risk could be higher among Asian population because of the reduced enzymatic activity of some of the alcohol metabolizing enzymes. Thus, through this study, the investigators hope to find out the risk factors of colorectal cancer among Taiwanese population, including alcohol metabolizing enzyme gene polymorphisms and their interaction with environmental factors, to attain the purpose of early prevention of colorectal cancer.

The purpose of this study is to find out relationship between alcohol metabolizing enzyme gene polymorphism and colorectal cancer, and discuss the impact of the interaction between gene polymorphism and environmental factors on the risk of colorectal cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study on Umorestat Hydrogen Sulfate Capsule in Patients With Locally Advanced/Metastatic Pancreatic Cancer	NCT05329597	Pharmacokinetic... Pancreatic Canc... Gene Polymorphi...	Genotyping	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Satraplatin and Prednisone to Treat Prostate Cancer	NCT00634647	Prostate Cancer Genetic Polymor...	Satraplatin prednisone	18 Years -	National Institutes of Health Clinical Center (CC)
Alcohol Intake, Alcohol Metabolizing Enzymes Gene Polymorphisms and the Risk of Colorectal Cancer	NCT03155542	Colorectal Neop...		20 Years -	National Taiwan University Hospital

Spots Global Cancer Trial Database for gene polymorphisms