- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00898027
Effect of Epidermal Growth Factor Receptor Inhibitors on Magnesium Homeostasis in Patients With Cancer
Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on Magnesium Homeostasis
RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer receiving epidermal growth factor receptor inhibitors may help doctors understand the effect of epidermal growth factor receptor inhibitors on magnesium levels in the body.
PURPOSE: This laboratory study is looking at the effect of epidermal growth factor receptor inhibitors on magnesium homeostasis in patients with cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the effects of EGFR inhibitors on magnesium homeostasis in patients with cancer.
OUTLINE: This is a pilot study.
Patients undergo blood and urine sample collection at baseline and at 2, 4, and 8 weeks during treatment.
After finishing treatment, patients are followed periodically for up to 10 weeks.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Diagnosis of malignancy
- Planning to receive therapy with an inhibitor of the EGFR pathway (either on or off a clinical trial and may be monotherapy or combined with other therapies)
- Normal serum magnesium level
Exclusion Criteria:
- Glomerular filtration rate ≥ 60 mL/min
- No severe underlying renal dysfunction
- Normal serum potassium and calcium level
- No history of primary or secondary hyperparathyroidism
PRIOR CONCURRENT THERAPY:
- No prior EGFR pathway inhibitor
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effects of EGFR inhibitors on magnesium homeostasis
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- VICC GI 0615
- VU-VICC-GI-0615
- VU-VICC-IRB-060364
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Solid Tumor
-
Memorial Sloan Kettering Cancer CenterRecruitingSolid Tumor | Solid Tumor, Adult | Solid Tumor, Unspecified, AdultUnited States
-
Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRecruitingSolid Tumor | Solid Tumor, Adult | Solid Tumor, Unspecified, AdultUnited States, Puerto Rico
-
Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRecruitingSolid Tumor | Solid Tumor, Adult | Solid Tumor, Unspecified, AdultUnited States, Puerto Rico
-
Sorrento Therapeutics, Inc.WithdrawnSolid Tumor | Relapsed Solid Tumor | Refractory Tumor
-
Aadi Bioscience, Inc.RecruitingAdvanced Solid Tumor | Tumor | Tumor, SolidUnited States
-
RemeGen Co., Ltd.CompletedMetastatic Solid Tumor | Locally Advanced Solid Tumor | Unresectable Solid TumorAustralia
-
Impact Therapeutics, Inc.RecruitingSolid Tumor | Advanced Solid TumorChina, Taiwan, United States, Australia
-
Partner Therapeutics, Inc.WithdrawnSolid Tumor | Solid Tumor, AdultUnited States
-
Shenzhen Ionova Life Sciences Co., Ltd.Merck Sharp & Dohme LLCRecruitingCancer | Solid Tumor, Adult | Solid Carcinoma | Solid Tumor, Unspecified, Adult | Cancer Metastatic | Tumor, SolidUnited States
-
BeiGeneRecruitingSolid Tumor | Advanced Solid TumorUnited States, New Zealand, Australia, China
Clinical Trials on laboratory biomarker analysis
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedProstate Cancer
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingLeukemia | Acute Lymphoblastic Leukemia | Acute Promyelocytic LeukemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUntreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic LeukemiaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung CancerUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnClear Cell Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Congenital Mesoblastic Nephroma | Childhood Kidney NeoplasmUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)WithdrawnBreast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation CarrierUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedWilms Tumor and Other Childhood Kidney TumorsUnited States