Malignant Neoplasm Clinical Trial
Official title:
POPULATION PHARMACOMETRICS FOR ASSESSING RISK OF BISPHOSPHONATE-RELATED OSTEONECROSIS OF THE JAW (BRONJ)
This randomized clinical trial studies genetics in predicting risk of bisphosphonate-related osteonecrosis of the jaw in patients with cancer receiving zoledronic acid. Zoledronic acid is an anti-resorptive drug used as part of cancer treatment. A serious side effect of these drugs is death of the jawbone, commonly called bisphosphonate-related osteonecrosis of the jaw (BRONJ). Genetic research may help doctors understand risk factors for BRONJ or who is more likely to get BRONJ and why.
PRIMARY OBJECTIVES:
I. To develop a pharmacometric model to predict jawbone zoledronic acid (Zol) concentrations
in oncologic patients by conducting a prospective cohort study of Zol pharmacometrics in
BRONJ patients, measuring drug in plasma, urine, and jawbone tissue obtained during surgical
treatment for BRONJ.
SECONDARY OBJECTIVES:
I. To clinically assess and validate our predictive pharmacometric model, and develop a risk
model for BRONJ in oncologic patients receiving intravenous Zol.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive zoledronic acid intravenously (IV) over 15 minutes on day 1.
ARM II: Patients receive zoledronic acid IV over 30 minutes on day 1.
After completion of study treatment, patients are followed up for 1 month.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02243592 -
Molecular Profiling in Tissue Samples From Patients With Cancer Who Are Exceptional Responders to Treatment
|
||
| Completed |
NCT03445572 -
Meditative Slow Breathing or Isha Kriya Meditation in Improving Cancer-Related Symptoms in Hospitalized Participants With Cancer
|
N/A | |
| Active, not recruiting |
NCT02860039 -
High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant
|
Phase 2 | |
| Completed |
NCT01946217 -
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
|
N/A | |
| Completed |
NCT01635413 -
Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)
|
N/A | |
| Completed |
NCT00026169 -
Imatinib Mesylate in Treating Patients With Advanced Cancer and Kidney Failure
|
Phase 1 | |
| Recruiting |
NCT04534075 -
Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial
|
Phase 3 | |
| Active, not recruiting |
NCT01806129 -
Reproductive Health Program in Patients With Cancer
|
N/A | |
| Recruiting |
NCT03915717 -
Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring
|
||
| Recruiting |
NCT02280161 -
Germ-Line Mutations in Blood and Saliva Samples From Patients With Cancer
|
||
| Recruiting |
NCT05520281 -
Short-term Psychodynamic Psychotherapy in Serious Physical Illness
|
N/A | |
| Terminated |
NCT00532064 -
Cardiac Biomarkers in Early Detection of Cardiotoxicity in Patients Receiving Sunitinib or Sorafenib Chemotherapy
|
||
| Completed |
NCT04990882 -
FAPI PET/CT Prospective Interobserver Agreement
|
||
| Completed |
NCT01896778 -
Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer
|
N/A | |
| Recruiting |
NCT05770102 -
DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Teenage/Young Adults and Paediatric Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition
|
Phase 2/Phase 3 | |
| Recruiting |
NCT06090266 -
A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05886764 -
Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials
|
N/A | |
| Completed |
NCT01506440 -
Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy
|
||
| Completed |
NCT01432431 -
Spiritual Care in Improving Quality of Life of Patients, Caregivers, and Hospital Staff
|
N/A |