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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: Completed Phase 1 study of Solid Tumors, sponsored by BPGbio.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Tumors will be assessed by standard methods ex. computerized tomography (CT), MRI etc; at baseline and then once every two treatment cycles of 28 days (2 months) thereafter in the absence of clinical rapid progression of disease. Assessment of tumor vascularity (using DCE-MRI) for at least 6 subjects who received C31510 at the MTD, will be done within 24 hours pre-dose and post-dose.
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 |
What the finished NCT01251562 record still lists
NCT01251562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (82% lower).
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 a single indexed study location in 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.
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 NCT01251562's enrollment target sits among peer trials
50 80th of 125 higher than 45 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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