Clinical trials: Cancer Surveillance
Breast Cancer
An Observational Study of Herceptin SC Safety in Breast Cancer
This is a phase IV, prospective, multicenter, observational study (regulatory post-marketing surveillance) in approximately 600 patients who are to receive Herceptin SC (trastuzumab, subcutaneous administration) per approved…
- Trial name
- NCT02305628
- Where
- 23 sites in South Korea
- Volunteers
- 600 people
- Sponsor
- Hoffmann-La Roche
Bladder Cancer
A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
The objective of this prospective, multi-centre study is to evaluate the performance of ADXBLADDER, a urine MCM5 ELISA test, as an aid in the detection of bladder cancer recurrence.
- Trial name
- NCT05508568
- Testing
- ADXBLADDER
- Where
- 13 sites in United States
- Volunteers
- 650 people
- Sponsor
- Arquer Diagnostics Ltd
Chronic Lymphocytic Leukemia
A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia
The purpose of this study is to assess safety and effectiveness of extended bendamustine in the treatment of chronic lymphocytic leukemia (CLL).
- Trial name
- NCT01739491
- Testing
- No intervention
- Sponsor
- Janssen Pharmaceutica
Lymphoma
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)
To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter…
- Trial name
- NCT03098589
- Testing
- Revlimid
- Where
- Japan
- Volunteers
- 1,149 people
- Sponsor
- Celgene
Carcinoma, Squamous Cell of Head and Neck
A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
This is a prospective, observational, non-interventional, multicenter, post-marketing surveillance study to mainly collect safety information from subjects with locally advanced and recurrent/metastatic Squamous Cell Carcinoma of…
- Trial name
- NCT01080066
- Testing
- No Intervention
- Where
- Taiwan
- Volunteers
- 215 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Chronic Lymphocytic Leukemia, Follicular Lymphoma
Observational Study to Monitor Safety and Effectiveness of Obinutuzumab in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia
This study aims to collect clinical data, mainly focused on safety, in the local target population as per the requirement of Korea Ministry of Food and Drug Safety for market authorization.
- Trial name
- NCT03374137
- Testing
- obinutuzumab
- Where
- 17 sites in South Korea
- Volunteers
- 55 people
- Sponsor
- Hoffmann-La Roche
BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor
Special Drug Use-results Surveillance of Tafinlar/Mekinist
This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture.
- Trial name
- NCT06262919
- Testing
- Tafinlar/Mekinist
- Where
- 70 sites in Japan
- Volunteers
- 110 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer
A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance
The primary purpose of this study was to compare the time to prostate cancer progression (pathological or therapeutic progression) between patients treated with enzalutamide versus patients undergoing active surveillance.
- Trial name
- ENACT (NCT02799745)
- Testing
- Enzalutamide, Active Surveillance
- Where
- 54 sites in United States, Canada
- Volunteers
- 227 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Gastric Cancer
An Observational Study of Herceptin (Trastuzumab) in Patients With HER2-positive Advanced Gastric Cancer
This observational, multicenter study will assess the efficacy and safety of Herceptin (trastuzumab) in routine clinical practice in patients with HER2-positive advanced adenocarcinoma of the stomach or gastro-esophageal…
- Trial name
- NCT01220934
- Where
- Germany
- Volunteers
- 443 people
- Sponsor
- Hoffmann-La Roche
Carcinoma, Hepatocellular
Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Nexavar for unresectable hepatocellular carcinoma (HCC).
- Trial name
- NCT01411436
- Testing
- Sorafenib (Nexavar, BAY43-9006)
- Where
- Japan
- Volunteers
- 1,637 people
- Sponsor
- Bayer
Colorectal Neoplasms
A Korean Post-marketing Surveillance Study on Erbitux® in Patients With Metastatic Colorectal Cancer Refractory to Irinotecan-containing Treatment
After consultation with the Korean Health Authorities, the two Post-Authorization Safety Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one study protocol EMR 062202-551.
- Trial name
- NCT01082315
- Testing
- Erbitux (Cetuximab)
- Where
- South Korea
- Volunteers
- 730 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Multiple Myeloma
A Study of Real-World Use of Ixazomib Citrate in People With Multiple Myeloma (MM)
In this study, people with MM will be treated with ixazomib citrate according to their clinic's standard practice. The main aim of the study is to check for side effects from ixazomib citrate.
- Trial name
- NCT04840680
- Testing
- No Intervention
- Where
- 20 sites in South Korea
- Volunteers
- 191 people
- Sponsor
- Takeda
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India
This study will follow patients with metastatic hormone-sensitive prostate cancer in India who receive darolutamide plus androgen deprivation therapy as part of routine medical care.
- Trial name
- PACE mHSPC (NCT07806591)
- Testing
- Darolutamide plus androgen deprivation therapy
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Bayer
Colorectal Neoplasms
Regorafenib Post-marketing Surveillance
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for colorectal cancer.
- Trial name
- NCT01843400
- Testing
- Regorafenib (Stivarga, BAY73-4506)
- Where
- Japan
- Volunteers
- 1,301 people
- Sponsor
- Bayer
Head and Neck Cancer
Prospective, Post Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck in Korea
After consultation with the Korean Health Authorities, the two Post-Authorization Safety Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one study protocol EMR 062202-551.
- Trial name
- NCT01075828
- Testing
- Cetuximab
- Where
- South Korea
- Volunteers
- 221 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Breast Cancer
AryoTrust® (Trastuzumab) Safety Study
This study was a phase IV, observational, multicenter, single-arm, open-label, post-marketing surveillance study for the assessment of AryoTrust safety in Iranian HER2-positive breast cancer patients undergoing adjuvant…
- Trial name
- NCT06021379
- Testing
- Trastuzumab
- Where
- 15 sites in Iran
- Volunteers
- 597 people
- Sponsor
- AryoGen Pharmed Co.
Neuroendocrine Tumors
A Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072
The purpose of the protocol is to evaluate the long-term safety of medicine 177Lu-satoreotide tetraxetan (also known as 177Lu-IPN01072 or 177Lu-OPS201) for patients who have previously received 177Lu-satoreotide tetraxetan in the…
- Trial name
- NCT05017662
- Testing
- Data collection
- Where
- 7 sites in Australia, Austria and 4 more
- Volunteers
- 20 people
- Sponsor
- Ariceum Therapeutics GmbH
Leukemia, Myelomonocytic, Chronic, Leukemia-Lymphoma
Korean Post-marketing Surveillance for Sprycel®
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Sprycel® so that the regulatory…
- Trial name
- NCT01464047
- Where
- South Korea
- Volunteers
- 670 people
- Sponsor
- Bristol-Myers Squibb
Multiple Myeloma
A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg
1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form…
- Trial name
- NCT02921828
- Where
- 2 sites in United States, Japan
- Volunteers
- 1,149 people
- Sponsor
- Celgene
Cancer
Regulatory TYKERB® Tablets PMS
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients according to the prescribing information TYKERB® is…
- Trial name
- NCT00975988
- Testing
- TYKERB® tablets
- Where
- 2 sites in South Korea
- Volunteers
- 750 people
- Sponsor
- GlaxoSmithKline