Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Behaviors and Mental Disorders

Critical Illness

Prostatic Neoplasms

Fatigue

Anemia

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Hematologic Diseases

Quality of Life

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Hematinics

Hormones

Chrysarobin

Epoetin Alfa

Darbepoetin alfa

Darbepoetin Alfa

Michael Borre, MD, PhD

The purpose of this study is to determine whether or not Aranesp® (Darbepoetin Alfa), administered every fourth week, is effective in the treatment of blood shortage (anemia) compared to standard care of treatment (blood transfusions) in patients with anemia due to hormone refractory prostate cancer.

In the past, prostate cancer has been regarded a relatively benign disease, which elderly men were expected to die with rather than from, however, prostate cancer has become the second most common non-skin cancer in Danish men and the second most common cause of male cancer death. Two out of three patients with clinically significant prostate cancer die from and not with their cancer disease, and the misery of this population is evident. Regular treatments with opiates or equivalent drugs as well are required in nearly one third of the patients.

Patients with advanced hormone insensitive (refractory) prostate cancer have a median survival rate of about one year and during this time they often suffer from anemia due to reasons like blood loss, tumor infiltration of the bone marrow and even treatment with androgen deprivation. Compared to patients with other cancer types patients with prostate cancer have a significantly lower mean haemoglobin level. However, patients with hormone refractory prostate cancer have not previously been given much attention and the treatment of the frequent condition of chronic anemia in this group of patients seems casual. Therefore, Best Standard of Care (BSC) is defined as RBC transfusion if the hemoglobin is \< 5,0 mmol/L (8,0 g/dl), and if there are signs or symptoms of anemia and supplemental iron if se-ferritin \< 200 mcg/L.

Very little is known about erythropoietin treatment and quality of life in hormone refractory prostate cancer patients. A randomized Swedish study did investigate the influence of two different doses of epoetin beta on quality of life, hemoglobin level, need for red blood cell transfusion and safety, in the treatment of anemia in 180 patients suffering from advanced hormone-refractory prostate cancer. This study found the treatment to be safe and effective for the treatment in many of these patients. In many of these critically ill patients, the treatment improved quality of life and relieved fatigue symptoms.

Darbepoetin alpha (Aranesp®) is produced by gene-technology in Chinese Hamster Cells (CHO-K1). It has a biological effect and toxicity profile comparable to r-HuEPO; with the exception of a longer half-life which means that it can be administered less frequently without loosing clinical efficiency. Aranesp® has been well tolerated in studies conducted to this date. In this setting Aranesp® appears to be safe and well tolerated. Adverse events reported to date have generally been mild to moderate in severity and consistent with events and symptoms in cancer patients with chronic disease receiving chemotherapy (i.e. fatigue and gastrointestinal symptoms). Clinical studies have shown a higher frequency of thromboembolic reactions including deep vein thrombosis and pulmonary embolism in cancer patients receiving Aranesp therapy compared to patients receiving placebo. The clinical experience so far with Aranesp® has been published (15,16,17). Aranesp® is registered for clinical use in Europe and US.

Based on this the present study will evaluate the effect of Aranesp® on the haematopoietic response in patients with advanced hormone independent prostate cancer and anemia. Moreover, the effect of Aranesp® on quality of life, hemoglobin, necessity for RBC transfusion and hospital admissions, will be evaluated. The study will be performed as an open randomized trial. The use of r-HuEPO in cancer patients has been established and registered in other settings (as supportive treatment), and it has been shown that the preparation can be given without significant side effects. On the contrary, it is likely that patients may benefit from additional improvement in wellbeing.

Effect of Darbepoetin Alfa (Aranesp®) on Anemia in Patients With Advanced Hormone Independent Prostate Cancer

A Randomized, Multi-center Study to Assess the Effect of Darbepoetin Alfa (Aranesp®) for the Treatment of Anemia in Patients With Advanced Hormone Independent Prostate Cancer and Anaemia

Amgen

University of Aarhus

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

Decitabine

Antimetabolites

Enzyme Inhibitors

Therapeutic effect and safety of 10 days of decitabine. Acute myeloid leukemia,no acute promyelocytic leukemia.

1. Number of Cycles: 4 cycles.
2. Dose and drug delivery(decitabine):

The 1st cycle: 20 mg/m2, (iv,\>1 hour) d1-10 of each 28 day cycle. The 2nd-4th cycle:If bone marrow blast cells≥5%, the following cycle is the same as the 1st cycle.

If bone marrow blast cells\<5%, the following cycle:decitabine 20 mg/m2, (iv,\>1h) on d1-5 of each 28 day cycle.

If Grade 4 neutropenia（\<0.5×10E9/L）come arise after 5 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 4 days(20 mg/m2, IV ,\>1h, on d1-4 of each 28 day cycle).If Grade 4 neutropenia（\<0.5×10E9/L）come arise after 4 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 3 days(20 mg/m2, IV,\>1h, on d1-3 of each 28day cycle).

Jianxiang Wang, MD

The purpose of this study is to confirm the safety and the therapeutic effect of Decitabine in the treatment of elderly Acute Myeloid Leukemia (AML) patients.

The outcome of the elderly AML patients is very poor. No obvious progress was achieved in this field. Decitabine is a kind of specific DNA methylation shift enzyme inhibitor. It can reverse the DNA methylation and induce the differentiation and apoptosis of the tumor cells. Recent studies about decitabine in the treatment for elderly AML patients had achieved inspiring results and indicated that low dose decitabine maybe a good choice for elderly AML patients. So in this research the investigators plan to evaluate the safety and the therapeutic effect of decitabine in the treatment of elderly AML patients.

Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia Patients

The Clinical Research About the Therapeutic Effect and Safety of 10 Days Regimen With Single-agent of Decitabine for Elderly AML Patients

Xian-Janssen Pharmaceutical Ltd.

Jianxiang Wang

deputy director

Digestive System Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

S-1: 60mg twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.

Paclitaxel: 150 mg/m2, iv, 3h, at D1

Dose of S-1: 60mg bid，Twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.

Dose of Paclitaxel: 150 mg/m2, iv, 3h, at D1

S-1 + Paclitaxel Chemotherapy

xiangdong Cheng, MD

Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients with Unresectable Gastric Cancer

To assess the effectiveness and safety of S-1 + Paclitaxel for the peri-operative chemotherapy in Chinese patients with unresectable gastric cancer, so as to further find out the optimal protocol for the peri-operative chemotherapy in the patients with gastric cancer.

Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Unresectable Gastric Cancer

Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients With Unresectable Gastric Cancer

Zhejiang Cancer Hospital

Heart and Blood Diseases

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antibodies

Immunoglobulins

Immunoglobulin M

Immunoglobulins, Intravenous

Immunologic Factors

Intravenous infusion of the anti-GRP78 monoclonal IgM antibody PAT-SM6 group 1: 0.3mg/kg Group 2: 1.0mg/kg Group 3: 3mg/kg Group 4: 6mg/kg

Anti-GRP78 monoclonal IgM antibody PAT-SM6

Max Top, MD

Primary

- To evaluate the safety and tolerability of escalating doses of an intravenous (i.v.) infusion of PAT-SM6 in subjects with relapsed or refractory multiple myeloma.

Secondary

* To evaluate the efficacy and pharmacodynamics by analysis of serum and urine M protein, serum free light chains (FLC) κFLC and λFLC, total immunoglobulins, β2-microglobulin, C-reactive protein (CRP), exploratory biomarkers and anti-PAT-SM6 antibodies.
* To evaluate the duration of response and the progression free survival.

Open-label, single-centre, dose escalation phase I study designed to investigate the safety and tolerability of intravenous (i.v.) infusions of PAT-SM6 administered over 90 minutes.

A screening examination will be performed within 14 days prior to dosing. Eligible subjects will receive 4 doses of PAT-SM6 (cycle 1: Day 1 and Day 3, cycle 2: Day 8 and Day 10). Subjects will be hospitalised for at least 48 hours after each dose administration (i.e. from Day 1 to Day 5 in cycle 1 and from Day 8 to Day 12 in cycle 2). During hospitalisation subjects will be under constant surveillance. Subjects will return for ambulatory visits on Days 15, 22, 29 and 36 for safety, pharmacokinetic (PK) and pharmacodynamic (PD) assessments.

Serological staging will be performed at baseline, on Day 29 (+/- 2 days) and Day 36 (+/-2 days). Response will be assigned by the International Myeloma Working Group (IMWG) uniform response criteria for multiple myeloma. Complete response (CR) will be confirmed by bone marrow aspiration; CT scans or other radiograph are only intended when clinical symptoms are suspicious for progressing disease or otherwise clinically indicated.

If a subject shows an at least partial response (PR) on Day 29 or Day 36 (4 doses) the sponsor discusses with the Data Safety Monitoring Board (DSMB) to give an additional 2 doses (therefore the maximal number of doses for each subject is 6 doses) and a further staging will be performed 14 and 21 days after the last dose administration.

A completion visit will be performed 4 days after the last serological staging (e.g. after cycle 2 on Day 40).

Four dose groups (cohorts) are planned: 0.3 mg/kg followed by doses of 1 mg/kg, 3 mg/kg and 6 mg/kg. Subjects will be enrolled in a strict sequential order.

Individual safety results obtained until Day 5 will be evaluated by the investigator and the sponsor before the next subject of the same dose group will be treated. After completion of all 3 subjects of a dose group, safety results of all subjects obtained until Day 15 will be reviewed by the DSMB and a decision for dose escalation will be made. Interim doses can be administered if the increase is thought to be too high.

Subjects who show definite signs of progressive disease including hypercalcemia, new osteolytic lesions or new soft tissue plasmocytoma will be withdrawn from the study at any time.

In case dose limited toxicity (DLT) was seen in a subject, further dosing of subjects in the same dose group will be discussed with the DSMB, in case of a second DLT in the same dose group dose escalation will be stopped and the study will be continued at the next lower intermediate dose level or the previous tested dose will be regarded as the maximum tolerated dose (MTD). The MTD is defined as the dose level below the dose inducing a DLT in 2 subjects within one dose level.

Safety and Preliminary Efficacy Study of the Antibody PAT-SM6 in Patients With Relapsed or Refractory Multiple Myeloma

Open-label, Single-centre, Phase I, Multi-dose Escalating Study to Investigate the Safety and Preliminary Efficacy of an i.v. Infusion of the Anti-GRP78 Monoclonal IgM Antibody PAT-SM6 in Patients With Relapsed or Refractory Multiple Myeloma

Patrys Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Darbepoetin Alfa (Aranesp®) on Anemia in Patients With Advanced Hormone Independent Prostate Cancer	NCT00381836	Prostatic Neopl... Anemia	Darbepoetin Alf...	18 Years -	University of Aarhus
Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia Patients	NCT01633099	Untreated Adult... Effect of Drugs Drug Safety	Decitabine	60 Years -	ChineseAMS
Effect of Darbepoetin Alfa (Aranesp®) on Anemia in Patients With Advanced Hormone Independent Prostate Cancer	NCT00381836	Prostatic Neopl... Anemia	Darbepoetin Alf...	18 Years -	University of Aarhus
Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Unresectable Gastric Cancer	NCT01756183	Surgically-Crea... Drug Safety	S-1 + Paclitaxe...	18 Years - 75 Years	Zhejiang Cancer Hospital
Safety and Preliminary Efficacy Study of the Antibody PAT-SM6 in Patients With Relapsed or Refractory Multiple Myeloma	NCT01727778	Drug Safety	Anti-GRP78 mono...	18 Years -	Patrys Ltd.

Spots Global Cancer Trial Database for drug safety

Every month we try and update this database with for drug safety 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 drug safety

Every month we try and update this database with for drug safety 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 drug safety 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.