BridgeMD
New treatment option for Bone Pain
Official title Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain
ClinicalTrials.gov ID: NCT07197645
What this study is testing
What is 153Sm-DOTMP?
153Sm-DOTMP is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bone pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open label, 2-part early phase study designed to evaluate the safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy of TLX090-Tx in patients with painful bone metastases.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants have had disease progression while on anti-cancer treatment, and are not eligible for the treatments, or their lesions are not amenable...
- Participants must have a histologically confirmed diagnosis of malignancy at any time prior to their participation in this clinical trial with...
- Participants must have bone cancer in one or more skeletal locations as identified by a 99mTc-diphosphonate bone scan within 60 days of dosing. At...
- Renal function, defined as a measured creatinine clearance (CrCl) ≥30 mL/min as per Cockroft Gault or based on radioisotope glomerular filtration...
- Hematologic function, defined as a platelet count of \>100,000 cells/mm3 and an Absolute neutrophil count (ANC) of \>1000 cells/mm3.
You likely can't join if
- Participants are pregnant or breastfeeding.
- Participants who have received maximum tolerable radiation to the spinal cord, have untreated pathologic bone fracture, spinal cord compression...
- Participants with a bone scan pattern showing diffuse, intense skeletal uptake with absent or faint kidney / bladder activity, typically indicating...
- Participants with impending or suspected or at high risk for spinal cord compression.
- Participants with neurogenic pain or significant pain associated with soft tissue lesions or other pain that, in the opinion of the Investigator...
- Participants who require surgery over their trial period that would require pain medication or analgesia.
See the full eligibility criteria
- Participants have had disease progression while on anti-cancer treatment, and are not eligible for the treatments, or their lesions are not amenable to palliative EBRT.
- Participants must have a histologically confirmed diagnosis of malignancy at any time prior to their participation in this clinical trial with multiple metastatic bone lesions with at least 1 metastatic painful...
- Participants must have bone cancer in one or more skeletal locations as identified by a 99mTc-diphosphonate bone scan within 60 days of dosing. At least one lesion must be osteoblastic. If described as osteosclerotic...
- Renal function, defined as a measured creatinine clearance (CrCl) ≥30 mL/min as per Cockroft Gault or based on radioisotope glomerular filtration rate (GFR).
- Hematologic function, defined as a platelet count of \>100,000 cells/mm3 and an Absolute neutrophil count (ANC) of \>1000 cells/mm3.
- Hemoglobin ≥8 g/dL.
- Liver function:
- Total bilirubin ≤1.5 × the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 × ULN with participants with known liver metastases.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 × ULN with participants with Gilbert's Syndrome.
- Life expectancy of at least 16 weeks from the date of study drug administration (Day 1).
- Karnofsky performance status \>60%, assessed during the screening period prior to study drug administration.
- Participants are pregnant or breastfeeding.
- Participants who have received maximum tolerable radiation to the spinal cord, have untreated pathologic bone fracture, spinal cord compression, unstable spine, or imminent long bone fracture.
- Participants with a bone scan pattern showing diffuse, intense skeletal uptake with absent or faint kidney / bladder activity, typically indicating widespread bone metastases or high bone turnover from metabolic or...
- Participants with impending or suspected or at high risk for spinal cord compression.
- Participants with neurogenic pain or significant pain associated with soft tissue lesions or other pain that, in the opinion of the Investigator, might interfere with the assessment of pain relief for bone tumors.
- Participants who require surgery over their trial period that would require pain medication or analgesia.
- Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.
- History of unstable angina (defined as angina at rest) or new-onset angina diagnosed within the 3 months prior to screening.
- History of myocardial infarction within 3 months prior to screening, as determined by medical history / Baseline ECG.
- Uncontrolled cardiac arrhythmias (≥Grade 3 CTCAE version 5.0) or any history of ≥Grade 3 arrhythmia.
- Congestive heart failure ≥New York Heart Association Class 2.
- Clinically significant abnormalities on ECG at screening including corrected QT interval (Fridericia's formula) \>450 msec for males or 470 msec for females at screening.
- Inability to complete the needed investigational and standard imaging examinations due to any reason (eg, severe claustrophobia, inability to lie still for the entire imaging time).
- Presence of any other condition that may increase the risk associated with study participation or interfere with the interpretation of study results, and, in the opinion of the study Investigator, would make the...
- Participants with active infections (human immunodeficiency virus, human papillomavirus. Hepatitis A, Hepatitis B, and Hepatitis C).
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.