An Early Phase 1 interventional study of [90]Y-DOTATOC in Neuroendocrine Tumors, sponsored by Sandeep Laroia. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by Sandeep Laroia · Early Phase 1, Interventional, and Treatment
This is a safety study to determine the phase 1 starting dose of [90]Yttrium-DOTATOC when it is administered intravenously for patients with neuroendocrine tumors that have spread to the liver.
[90]Yttrium-DOTATOC is a radioactive drug used for peptide receptor radionuclide therapy (PRRT). In other studies, 90Y-DOTATOC has been administered through a vein (IV) to target somatostatin receptor positive tumor tissue. The DOTATOC identifies the tumor through the somatostatin receptor and links to it, attaching the radioactive molecule 90Yttrium to the malignant cell.
This study expands the initial work to examine if administering the drug 90Y-DOTATOC directly to the liver is safe for patients with neuroendocrine tumors whose disease has spread to their tumor. We don't know how of the 90Y-DOTATOC is safe to administer. We want to learn what the maximum safe dose is and what the side effects are related to that dose.
676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.
This study's enrollment of 3 is below the median of 42 across 464 interventional studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →This is the only study on the registry with Sandeep Laroia as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Subject will be administered 2.96 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver
Drug: [90]Y-DOTATOC
Subject will be administered 3.33 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver
Drug: [90]Y-DOTATOC
Subject will be administered 3.7 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver
Drug: [90]Y-DOTATOC
Subject will be administered 4.17 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver
Drug: [90]Y-DOTATOC
Subject will be administered 4.44 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver
Drug: [90]Y-DOTATOC
Subject will be administered 5.18 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver
Drug: [90]Y-DOTATOC
Intra-arterial infusion to the liver of \[90\]Y-DOTATOC. The administered dose is determined by cohort and is dependent upon the results of the previous cohort.
Also known as: 90Y-DOTATOC, 90Y-DOTA-Phe1-tyr3-Octreotide, [90]Yttrium-DOTATOC
Change in liver enzymes
Evaluate liver toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for liver enzymes
Time frame: Through 6 weeks after treatment
Change in platelet counts
Evaluate bone marrow toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for platelet count
Time frame: Through 6 weeks after treatment
Change in absolute neutrophil count
Evaluate bone marrow toxicity using using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for absolute neutrophil count
Time frame: Through 6 weeks after treatment
90Y-DOTATOC distribution
Determine the distribution of 90Y-DOTATOC using post-treatment imaging
Time frame: 48h post-infusion
Plan to share: Yes — Data will be shared as per approved IRB application and the subject's opt-in preferences. Data will not be provided from subjects who decline data sharing.
Supporting information: Study protocol, Sap, Icf
This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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