Neoplasms Clinical Trial
— ESPNVOfficial title:
A Multi-center, Stratified Randomized, Controlled Study to Evaluate the Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in China
NCT number | NCT01481831 |
Other study ID # | zhiruo |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | October 28, 2011 |
Last updated | December 28, 2012 |
Start date | July 2011 |
Verified date | December 2012 |
Source | Shanghai Changzheng Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
This purpose of this study is to evaluate the efficacy and safety of single and repeated doses of palonosetron hydrochloride in preventing nausea and vomiting caused by moderate and highly emetogenic chemotherapy in patients.
Status | Completed |
Enrollment | 599 |
Est. completion date | |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Patients candidates to a chemotherapy treatment, with histologically or cytologically confirmed malignant disease; 2. The concrete chemotherapy plan does not limited, group I (Highly Emetogenic Chemotherapy), group II (Moderately Emetogenic Chemotherapy); 3. Male or female aged 18-75 years, ECOG=2, estimates survival time=3 months; 4. WBC=3.0×109/L, ANC=1.5×109/L, PLT=80×109/L, total bilirubin=1.5×ULN(Normal value upper limit), AST and ALT=2.5×ULN(With transferability liver cancer=5×ULN), Cr and BUN=1.5×ULN, electrolyte and electrocardiogram are normal, conforms to the chemotherapy adaptation; 5. Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks); 6. Patients that voluntarily sign the consent form. Exclusion Criteria: 1. Pregnancy, or patients during breast feeding; 2. Patients have accepted any radiotherapy during the experimental period; 3. Gastric outlet or intestinal obstruction; 4. Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder; 5. Patients have epilepsy, or have been used psychotropic drug and calm drug; 6. Received any drugs with potential anti-emetic efficacy, or experienced any vomiting, nausea or retching in the 24 hours prior to chemotherapy; 7. Patients with transferability brain tumor, have vomiting caused by skull high pressure, or can not speak sickness situation and adverse reactions by self; 8. Patients have known hypersensitivity to 5-HT3 antagonists; 9. Patients have chemotherapy contraindications; 10. Patients are participating, or have participated in other Clinical studies of new drugs within 2 weeks. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Chinese Academy of Medical Sciences Cancer Hospital | Beijing | Beijing |
China | Chinese PLA 301 Hospital | Beijing | Beijing |
China | Chinese PLA 307 Hospital | Beijing | Beijing |
China | Chinese PLA Navy General Hospital | Beijing | Beijing |
China | The Second Xiangya Hospital of Central South University | Changsha | Hunan |
China | The First People's Hospital of Changzhou | Changzhou | Jiangsu |
China | Fuzhou General Hospital of Nanjing Military Command | Fuzhou | Fujian |
China | Anhui Provincial Hospital | Hefei | Anhui |
China | Shandong Cancer Hospital | Jinan | Shandong |
China | Shandong Provincial Hospital | Jinan | Shandong |
China | Nanjing General Hospital of Nanjing Military Command | Nanjing | Jiangsu |
China | Guangxi Cancer Hospital | Nanning | Guangxi |
China | The Affiliated Hospital of Medical College Qingdao University | Qingdao | Shandong |
China | Shanghai Changzheng Hospital | Shanghai | Shanghai |
China | Shanghai Xinhua Hospital | Shanghai | Shanghai |
China | The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu |
China | The Fourth People's Hospital of Wuxi | Wuxi | Jiangsu |
China | Tangdu Hospital of Fourth Military Medical University | Xian | Shanxi |
Lead Sponsor | Collaborator |
---|---|
Shanghai Changzheng Hospital | JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Response rate | defined as no emetic episode and no use of rescue medication | 2-7 days | No |
Secondary | Complete Response rate | defined as no emetic episode and no use of rescue medication | 0-24 hours, 0-7 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03826043 -
THrombo-Embolic Event in Onco-hematology
|
N/A | |
Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
Completed |
NCT01938846 -
BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06058312 -
Individual Food Preferences for the Mediterranean Diet in Cancer Patients
|
N/A | |
Completed |
NCT03308942 -
Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants
|
Phase 2 | |
Recruiting |
NCT06018311 -
Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads
|
N/A | |
Withdrawn |
NCT05431439 -
Omics of Cancer: OncoGenomics
|
||
Completed |
NCT01343043 -
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma
|
Phase 1 | |
Completed |
NCT01938638 -
Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer
|
Phase 1 | |
Recruiting |
NCT05514444 -
Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)
|
Phase 1 | |
Recruiting |
NCT02292641 -
Beyond TME Origins
|
N/A | |
Terminated |
NCT00954512 -
Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04958239 -
A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors)
|
Phase 1 | |
Recruiting |
NCT04627376 -
Multimodal Program for Cancer Related Cachexia Prevention
|
N/A | |
Completed |
NCT01222728 -
Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
|
||
Recruiting |
NCT06004440 -
Real World Registry for Use of the Ion Endoluminal System
|
||
Active, not recruiting |
NCT05636696 -
COMPANION: A Couple Intervention Targeting Cancer-related Fatigue
|
N/A | |
Not yet recruiting |
NCT06035549 -
Resilience in East Asian Immigrants for Advance Care Planning Discussions
|
N/A | |
Recruiting |
NCT06004466 -
Noninvasive Internal Jugular Venous Oximetry
|
||
Completed |
NCT02909348 -
Immunophenotyping of Melanoma Patients on Treatment With Pembrolizumab
|