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NCT01957280 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Pharmacokinetics, Immunogenicity and Safety/Tolerability of Patritumab (U3-1287)
A Phase 1 study of Solid Tumors, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 3
- Study locations
NCT01957280: Completed Phase 1 study of Solid Tumors, sponsored by Daiichi Sankyo.
NCT01957280 is a Phase 1 study of Solid Tumors that has completed, run by Daiichi Sankyo. The registered enrollment target is 17 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01957280, a Phase 1 study of Solid Tumors, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to assess the PK, safety, and tolerability of patritumab produced by a new manufacturing process (denoted as "Process 2 patritumab"). The data from this study will allow Process 2 patritumab to be compared to Process 1 patritumab to allow for any dose adjustments, if needed, and to bridge data from studies previously conducted with Process 1 patritumab to studies to be conducted with Process 2 patritumab. The hypothesis for this study is that the pharmacokinetics of Process 2 patritumab will be comparable to those of Process 1 patritumab.
Primary Outcome
AUC (0-21 day) of patritumab obtained after a single infusion of Process 2 patritumab 18 mg/kg (loading dose)
Conditions Studied
Interventions
- DRUG patritumab
Study Locations (3)
Florida
- - Tampa
Oklahoma
- - Oklahoma City
Texas
- - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
What the finished NCT01957280 record still lists
NCT01957280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which patritumab is the first listed.
NCT01957280 reports a single indexed study location in Florida, Oklahoma, Texas.
Frequently Asked Questions
What is clinical trial NCT01957280 about?
NCT01957280 is a clinical study titled "Study to Assess Pharmacokinetics, Immunogenicity and Safety/Tolerability of Patritumab (U3-1287)". The purpose of this study is to assess the PK, safety, and tolerability of patritumab produced by a new manufacturing process (denoted as "Process 2 patritumab"). The data from this study will allow Process 2 patritumab to be compared to Process 1 patritumab to allow for any dose adjustments, if nee...
What is the current status of trial NCT01957280?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2013-06. Estimated completion is 2014-04.
What conditions does trial NCT01957280 study?
This clinical trial studies the following conditions: Solid Tumors.
What interventions are being tested in trial NCT01957280?
The interventions under investigation include: patritumab (DRUG).
Who is sponsoring clinical trial NCT01957280?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01957280 being conducted?
This trial has 3 study locations across Florida, Oklahoma, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumors
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 NCT01957280's enrollment target sits among peer trials
17 118th of 125 higher than 7 of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumors 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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