Group II (lutetium Lu 177 dotatate, triapine) for Neuroendocrine Tumors

University of California Davis Comprehensive Cancer Center, Sacramento, CA
Neuroendocrine TumorsTriapine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial compares the effect of adding a drug to a radioactive medication to shrink or slow tumor growth in metastatic neuroendocrine tumors.

Eligible Conditions
  • Metastatic Neuroendocrine Tumors

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Up to 5 years

Pre- to post-triapine administration
Plasma deoxyribonucleosides
Year 5
Progression free survival (PFS)
Up to 5 years
Circulating deoxyribonucleic acid (ctDNA)
Overall response rate
Plasma hPG80

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Group I (lutetium Lu 177 dotatate)
1 of 2
Group II (lutetium Lu 177 dotatate, triapine)
1 of 2

Active Control

Experimental Treatment

94 Total Participants · 2 Treatment Groups

Primary Treatment: Group II (lutetium Lu 177 dotatate, triapine) · No Placebo Group · Phase 2

Group II (lutetium Lu 177 dotatate, triapine)Experimental Group · 5 Interventions: Triapine, Biospecimen Collection, Computed Tomography, Lutetium Lu 177 Dotatate, Magnetic Resonance Imaging · Intervention Types: Drug, Procedure, Procedure, Drug, Procedure
Group I (lutetium Lu 177 dotatate)ActiveComparator Group · 4 Interventions: Biospecimen Collection, Computed Tomography, Lutetium Lu 177 Dotatate, Magnetic Resonance Imaging · Intervention Types: Procedure, Procedure, Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triapine
2006
Completed Phase 1
~30
Biospecimen Collection
2004
Completed Phase 1
~810
Computed Tomography
2017
Completed Phase 2
~2710
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,275 Previous Clinical Trials
41,234,718 Total Patients Enrolled
74 Trials studying Neuroendocrine Tumors
10,381 Patients Enrolled for Neuroendocrine Tumors
Lowell B AnthonyPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
Aman ChauhanPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
2 Previous Clinical Trials
58 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
58 Patients Enrolled for Neuroendocrine Tumors

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had or currently have another type of cancer that will not affect the safety or effectiveness of the investigational treatment being studied.

Frequently Asked Questions

Are there any vacancies left in this research project?

"Clinicaltrials.gov reveals that this medical trial is currently open for enrollment, with the initial posting taking place on March 15th 2023 and its most recent update occurring a mere fortnight ago." - Anonymous Online Contributor

Unverified Answer

What is the current size of this research trial's participant pool?

"That is correct. According to clinicaltrials.gov, this medical trial opened on March 15th of 2021 and was recently updated on the 28th of that same month. Researchers are searching for 94 volunteers from a single site." - Anonymous Online Contributor

Unverified Answer

Has Group II (lutetium Lu 177 dotatate, triapine) been given the go-ahead by federal regulators?

"Our team at Power has assigned a score of 2 to Group II (lutetium Lu 177 dotatate, triapine) due to the fact that there is some safety data available from Phase 2 trials but no evidence yet demonstrating its efficacy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.