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NCT01495663 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of I-131-CLR1404 in Subjects With Cancer That Does Not Respond to Treatment or Has Returned
A Phase 1 study of Cancer, sponsored by Cellectar Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 3
- Study locations
NCT01495663: Completed Phase 1 study of Cancer, sponsored by Cellectar Biosciences.
NCT01495663 is a Phase 1 study of Cancer that has completed, run by Cellectar Biosciences. The registered enrollment target is 12 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01495663, a Phase 1 study of Cancer, has completed, sponsored by Cellectar Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to determine the recommended dose of I-131-CLR1404, a radiolabeled therapy compound, for treating subjects with cancer that does not respond to treatment or has returned. The identified recommended dose in this study will be used as the optimal dose of I-131-CLR1404 in subsequent clinical trials conducted for later phase clinical development. Subjects who meet study entry criteria will receive I-131-CLR1404. For each subject, the study will be conducted in two phases, dosimetric and therapy. In the dosimetric phase, subjects will receive one 5 mCi dose of the study drug and undergo whole body imaging on on the day of infusion and on post-infusion days 1, 2, 3, and 6 for assessment of biodistribution of I-131-CLR1404. If normal and expected biodistribution are demonstrated, the subject will begin the therapy phase. In the therapy phase, the first cohort of subjects will receive a dose of 12.5 mCi/m2. Dose escalation in subsequent cohorts will initially be in increments of 12.5 mCi/m2. Subjects will be followed and observed for unacceptable toxicity through 56 days after the therapy dose infusion with follow-up for up to one year. All subjects will be prescribed thyroid protection medication to be taken 24 hours prior to injection of the dosimetric dose, and continuing for 14 days after the administration of the therapy dose.
Primary Outcome
Largest administered dose with at most a 20% dose limiting toxicity rate
Conditions Studied
Interventions
- DRUG I-131-CLR1404
Study Locations (3)
California
- City of Hope National Medical Center - Duarte
District of Columbia
- Georgetown University Hospital - Washington D.C.
Wisconsin
- University of Wisconsin Hospital and Clinics - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
What the finished NCT01495663 record still lists
NCT01495663 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which I-131-CLR1404 is the first listed.
NCT01495663 reports a single indexed study location in California, District of Columbia, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01495663 about?
NCT01495663 is a clinical study titled "Dose Escalation Study of I-131-CLR1404 in Subjects With Cancer That Does Not Respond to Treatment or Has Returned". The purpose of this study is to determine the recommended dose of I-131-CLR1404, a radiolabeled therapy compound, for treating subjects with cancer that does not respond to treatment or has returned. The identified recommended dose in this study will be used as the optimal dose of I-131-CLR1404 in s...
What is the current status of trial NCT01495663?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2011-12. Estimated completion is 2014-01.
What conditions does trial NCT01495663 study?
This clinical trial studies the following conditions: Cancer.
What interventions are being tested in trial NCT01495663?
The interventions under investigation include: I-131-CLR1404 (DRUG).
Who is sponsoring clinical trial NCT01495663?
This trial is sponsored by Cellectar Biosciences, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01495663 being conducted?
This trial has 3 study locations across California, District of Columbia, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01495663's enrollment target sits among peer trials
12 594th of 615 higher than 18 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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