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NCT01498952 · ClinicalTrials.gov registry record · Phase 1
MEDI-573 in Combination With SOC in Unresectable or Metastatic HCC.
A Phase 1 study of Unresectable or Metastatic Hepatocellular Carcinoma (HCC), sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 3
- Study locations
NCT01498952: Completed Phase 1 study of Unresectable or Metastatic Hepatocellular Carcinoma (HCC), sponsored by MedImmune.
NCT01498952 is a Phase 1 study of Unresectable or Metastatic Hepatocellular Carcinoma (HCC) that has completed, run by MedImmune. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01498952, a Phase 1 study of Unresectable or Metastatic Hepatocellular Carcinoma (HCC), has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 3
- Study locations
Study Summary
A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard of care in adult subjects with unresectable or metastatic hepatocellular carcinoma (HCC).
Primary Outcome
The DLT was defined as any Grade 3 or higher hematologic or non-hematologic toxicity considered to be related to MEDI-573 that occurred during the DLT evaluation period (Days 1 to 21 of Cycle 1), with the exceptions of Grade 3 fever (occurred in the absence of neutropenia and resolved to normal or baseline within 24 hours of treatment and was not considered as SAE), Grade 3 rigors/chills that responded to optimal therapy, and Grade \< 4 hyperglycemia that resolved in \< 24 hours.
Conditions Studied
Interventions
- DRUG Sorafenib
- DRUG MEDI-573 (1 of 3 doses)
Study Locations (3)
California
- Research Site - Oxnard
Colorado
- Research Site - Golden Springs
Nevada
- Research Site - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-01-17 |
| Est. Completion | 2013-04-09 |
| Phase | Phase 1 |
What the finished NCT01498952 record still lists
NCT01498952 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Unresectable or Metastatic Hepatocellular Carcinoma (HCC) appearing as the primary indexed condition, and to 2 interventions - of which Sorafenib is the first listed.
NCT01498952 reports a single indexed study location in California, Colorado, Nevada.
Frequently Asked Questions
What is clinical trial NCT01498952 about?
NCT01498952 is a clinical study titled "MEDI-573 in Combination With SOC in Unresectable or Metastatic HCC.". A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard of care in adult subjects with unresectable or metastatic hepatocellular carcinoma (HCC).
What is the current status of trial NCT01498952?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2012-01-17. Estimated completion is 2013-04-09.
What conditions does trial NCT01498952 study?
This clinical trial studies the following conditions: Unresectable or Metastatic Hepatocellular Carcinoma (HCC).
What interventions are being tested in trial NCT01498952?
The interventions under investigation include: Sorafenib (DRUG), MEDI-573 (1 of 3 doses) (DRUG).
Who is sponsoring clinical trial NCT01498952?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01498952 being conducted?
This trial has 3 study locations across California, Colorado, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01498952's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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