Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTelix Pharmaceuticals (Innovations) Pty Limited
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 osteoblastic tumor that causes a minimum pain score of 4 on the NRS11.
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.
Disqualifiers
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 hematologic diseases (Superscan) pattern on Technetium 99-m bone scan scintigraphy - defined as diffusely increased skeletal uptake with absent or markedly reduced renal and soft tissue visualization - are excluded from the study.
Participants with impending or suspected or at high risk for spinal cord compression.
Trial design
Design model
Sequential
Treatments tested in this trial
153Sm-DOTMP
DrugTLX090-Tx will be administered as a single ascending intravenous dose to participants with at least 1 confirmed painful osteoblastic bone tumor that exhibits avid uptake as shown by 99mTcdiphosphonate bone scans undertaken within 60 days of dosing.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Part A - Cohort 1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of treatment-emergent adverse events (TEAEs) [Safety and Tolerability]
Incidence and severity of hematologic and non-hematologic toxicities, graded per CTCAE v5.0, assessed through 6 weeks post-dose.
Time frame
Up to 6 weeks post-doseSecondary outcomes
1
Change from baseline in patient-reported bone pain severity using the NRS-11 scale on the form
Change in pain score using NRS-11, assessed up to 16 weeks post-dose.
Time frame
Baseline to 16 weeks post-doseSponsors and contacts
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Source ClinicalTrials.gov