Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Leuprolide

Antineoplastic Agents, Hormonal

leuprolide acetate

The purpose of this study is to look at the efficacy and safety of leuprolide acetate in patients with prostate cancer.

Other assessments include evaluation of main leuprolide PK parameters in 12 subjects after administration of 3 doses.

Study Design:

This will be a multi-center, open-label, fixed investigation of six monthly dosages of leuprolide acetate 3.75 mg administered to patients with histologically proven carcinoma of prostate, who might benefit from medical androgen deprivation therapy.

A total of 120 male patients will receive a single, i.m. injection of leuprolide acetate 3.75 mg initially on study day 0 (after baseline assessment) and then monthly (i.e. every 28 days) for five months.

12 of the patients will also have plasma leuprolide levels measured for PK analysis during the first 3 injection periods (PK group). These patients will belong to pre-defined study sites.

Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer

Efficacy and Safety of a New Leuprolide Acetate 3.75 mg Depot Formulation, GP-Pharm S.A., When Given as Palliative Treatment to Prostate Cancer Patients

GP-Pharm

Radium Ra 223 dichloride

Single-arm cohort observational study with CRPC patients with bone metastasis treated with Radium-223.

This is a non-interventional study, the drug is used in its authorized indication from commercial supply. The decision to treat with Radium-223 will be agreed upon between the physician and the patient independently and prior to providing the patient study information. Treatment with Radium-223 should follow the approved local product information.

Radium-223 dichloride (Xofigo, BAY88-8223)

Bayer Study Director

Observational study in the routine clinical practice setting to evaluate the short and long term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients and to evaluate the risk of developing second primary cancers.

Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer

Radium-223 Alpha Emitter Agent in Non-intervention Safety Study in mCRPC popUlation for Long-teRm Evaluation

Therapeutic/prevention measures/treatment modalities, Gr. 3/4 hematological toxicities (up to 6 months after last administration), platelet or WBC \< lower limit of normal during treatment +30 days will be followed to resolution (up to 6 months after last administration), and febrile neutropenia and hemorrhage for patients who start subsequent chemotherapy will be assessed.

Bayer

Symptoms and General Pathology

Nervous System Diseases

Pain

Breakthrough Pain

Neurologic Manifestations

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

Fentanyl

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses

EN3267

Julian Howell

The purpose of this study is to evaluate the long-term safety and effectiveness of EN3267 in treating breakthrough pain episodes in opioid cancer patients who are using stable doses of opioid medication.

This was a Phase 3 non-randomized, open-label, multicentre study designed to evaluate the long-term safety of EN3267 in the treatment of BTcP in opioid-tolerant cancer patients. The study was conducted in 2 parts:

1. A Titration Period during which patients had up to 2 weeks to determine a single, effective dose of study medication (EN3267) for adequate treatment of BTcP, and
2. A maintenance Period of up to 12 months in which episodes of BTcP were treated with study medication.

Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients

A Multiple-Dose, Non-Randomized, Open-Label, Multicenter Study to Evaluate the Long-Term Safety and Effectiveness of EN3267 in the Treatment of Breakthrough Pain in Cancer Patients

Kyowa Kirin Co., Ltd.

EN3267: EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses

Sublingual Fentanyl Tablet

EN3267 : EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Fiona Miller

Patients with at least 1 AE

Patients with at least 1 AE causing discontinue

Patients with at least 1 SAE

Patients with an AE resulting in death

Titration

All patients enrolled who continued into the maintenance period

Maintenance

Combination of titration and maintenance period

Overall

Evaluate the Long-term Safety and Effectiveness of EN3267

Titration Period

Maintence Period

Blood and Lymph Conditions

Rare Diseases

Thrombocytopenia

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Blood Platelet Disorders

Cytopenia

Azacitidine

In this study 4 different doses of oral eltrombopag (50mg, 100mg, 200mg and 300mg) will be tested. A modified 3+3 patient cohorts design will be used so no new patients are accepted to start on a higher dose without prior tolerance at the previous dose. Patients will be given eltrombopag once daily starting one week before the start of azacitidine treatment and then continue throughout the study, which duration will be approximately 3 months (three Azacytidine cycles). Patients will be evaluated continuously by clinical and laboratory assessments as well as bone marrow examinations during the treatment period until 4 weeks after discontinuation of Eltrombopag. Response, AEs/SAEs and DLTs will be monitored throughout the study.

Eltrombopag

Tobias Svensson, M.D.

Patients with Myelodysplastic Syndromes (MDS) often suffer from low platelet levels which may lead to bleeding complications. Treatment with cytotoxic agents can decrease the platelet levels further. Eltrombopag is a relatively new drug that increases the platelet level in the blood by working directly on the bone marrow. It is available for treatment of the disease Immunological Thrombocytopenic Purpura (ITP). In this study patients with MDS and low platelet levels that are treated with the cytotoxic agent Azacitidine will also receive Eltrombopag. The administration of Eltrombopag to MDS patients treated with Azacitidine may result in less dose reductions and less treatment delays for Azacitidine and may reduce the need for thrombocyte transfusions and lower the risk of bleeding complications.

This is a phase I study, meaning that our major goal is to investigate the safety and tolerability for Eltrombopag in this patient group. It will also generate a basis for a phase II-III-study.

Safety Study of Eltrombopag Combined With Azacitidine to Treat Myelodysplastic Syndrome (MDS)

A Pilot Phase I Dose Finding Safety Study of a Thrombopoietin-receptor Agonist, Eltrombopag, in Patients With Myelodysplastic Syndrome Treated With Azacitidine

Including:

* Non-hematological clinical, laboratory Grade 3/Grade 4 toxicities
* Change in bone marrow or peripheral blood blast counts from baseline
* Adverse events and interactions at increasing doses of eltrombopag

GlaxoSmithKline

Nordic MDS Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer	NCT00128531	Prostate Cancer	leuprolide acet...	18 Years -	GP-Pharm
Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer	NCT02141438	Metastatic Cast...	Radium-223 dich...	18 Years -	Bayer
Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer	NCT02141438	Metastatic Cast...	Radium-223 dich...	18 Years -	Bayer
Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients	NCT00263575	Pain Cancer	EN3267	17 Years -	Kyowa Kirin Co., Ltd.
Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients	NCT00263575	Pain Cancer	EN3267	17 Years -	Kyowa Kirin Co., Ltd.
Safety Study of Eltrombopag Combined With Azacitidine to Treat Myelodysplastic Syndrome (MDS)	NCT01481220	Myelodysplastic... Thrombocytopeni...	Eltrombopag	18 Years -	Nordic MDS Group
Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients	NCT00263575	Pain Cancer	EN3267	17 Years -	Kyowa Kirin Co., Ltd.

Spots Global Cancer Trial Database for safety study

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