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NCT01251562 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Sterile Compound C31510 for Injection to Subjects With Solid Tumors
A Phase 1 study of Solid Tumors, sponsored by BPGbio.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT01251562 is a Phase 1 study of Solid Tumors that has completed, run by BPGbio. The registered enrollment target is 50 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01251562, a Phase 1 study of Solid Tumors, has completed, sponsored by BPGbio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this clinical study is as follows: • To determine the MTD and to assess the safety and tolerability of C31510 administered as a single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors The secondary objective of this study is as follows: • To evaluate plasma PK and estimate renal elimination of C31510 administered as a single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors The exploratory objectives of this study are as follows: * To evaluate the pharmacodynamic correlates of C31510 activity in plasma and peripheral blood cells * To radiographically evaluate the effects of C31510 on tumors. In selected subjects, the effects on vascular permeability will be assessed by digital contrast enhanced (DCE)-magnetic resonance imaging (MRI) * To evaluate tumor response (preliminary antitumor activity) after repeat administration of C31510 * Long-term safety and tolerability of C31510 after repeat administration
Conditions Studied
Interventions
- DRUG Sterile Compound C31510 for Injection
Study Locations (1)
California
- Sarcoma Oncology Center - Santa Monica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-01 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01251562
The ClinicalTrials.gov registry entry for NCT01251562 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (82% lower). The listed sponsor is BPGbio, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which Sterile Compound C31510 for Injection is the first listed.
NCT01251562 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01251562 about?
NCT01251562 is a clinical study titled "Safety Study of Sterile Compound C31510 for Injection to Subjects With Solid Tumors". The primary objective of this clinical study is as follows: • To determine the MTD and to assess the safety and tolerability of C31510 administered as a single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors The secondary objective of this study is as follows: • To...
What is the current status of trial NCT01251562?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2011-01. Estimated completion is 2014-05.
What conditions does trial NCT01251562 study?
This clinical trial studies the following conditions: Solid Tumors.
What interventions are being tested in trial NCT01251562?
The interventions under investigation include: Sterile Compound C31510 for Injection (DRUG).
Who is sponsoring clinical trial NCT01251562?
This trial is sponsored by BPGbio, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01251562 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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