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NCT00613691 · ClinicalTrials.gov registry record · Phase 1
A Phase I, Open-label, Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Endothelin B Agonist, SPI-1620, in Patients With Recurrent or Progressive Carcinoma
A Phase 1 study of Carcinoma, sponsored by Spectrum Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT00613691 is a Phase 1 study of Carcinoma that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 36 participants, below the 253-participant average among 29 other Carcinoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00613691, a Phase 1 study of Carcinoma, has completed, sponsored by Spectrum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 2-part, open-label, single-arm, dose escalation study. Part I will define the Maximum Tolerated Dose (MTD) and optimal dose of SPI-1620 and evaluate its PK and PD properties. Once the MTD for SPI-1620 is identified, a second phase of the study will focus on dose escalation of docetaxel studied in groups of 3-6 patients. This part of the study will assess the safety and tolerability of increasing doses of docetaxel administered with the optimal dose of SPI 1620 defined in Part I.
Conditions Studied
Interventions
- DRUG SPI-1620
Study Locations (1)
Texas
- START - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2008-01 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00613691
The ClinicalTrials.gov registry entry for NCT00613691 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 253-participant average among 29 other Carcinoma trials with a reported enrollment target (86% lower). The listed sponsor is Spectrum Pharmaceuticals, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which SPI-1620 is the first listed.
NCT00613691 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00613691 about?
NCT00613691 is a clinical study titled "A Phase I, Open-label, Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Endothelin B Agonist, SPI-1620, in Patients With Recurrent or Progressive Carcinoma". This is a 2-part, open-label, single-arm, dose escalation study. Part I will define the Maximum Tolerated Dose (MTD) and optimal dose of SPI-1620 and evaluate its PK and PD properties. Once the MTD for SPI-1620 is identified, a second phase of the study will focus on dose escalation of docetaxel stu...
What is the current status of trial NCT00613691?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2008-01. Estimated completion is 2012-12.
What conditions does trial NCT00613691 study?
This clinical trial studies the following conditions: Carcinoma.
What interventions are being tested in trial NCT00613691?
The interventions under investigation include: SPI-1620 (DRUG).
Who is sponsoring clinical trial NCT00613691?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00613691 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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