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A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC)
NCT01240590 · View on ClinicalTrials.gov ↗
Study Summary
Background: Anaplastic thyroid cancer (ATC) is one of the most aggressive of all solid tumors; chemotherapy and surgery have had no impact on local control or survival of patients, with a median survival of 3-7 months. Crolibulin (EPC2407) is a microtubulin inhibitor that has been shown to have direct antitumor effects in vivo and in vitro, destabilizing spindles and inducing apoptosis, resulting in the disruption of neovascular endothelial cells with disruption of blood flow to the tumor. Early clinical studies with combretastatin, from which crolibulin is derived, demonstrated efficacy in a subset of patients with ATC. Objectives: The primary objective in the Phase I portion is to assess the safety and tolerability of cisplatin and crolibulin given in a 21-day cycle in dose-seeking cohorts. We will assess the toxicities of crolibulin coadministered with cisplatin, evaluate dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) for the combination. The primary objective in the Phase II portion is to compare the combination crolibulin plus cisplatin versus cisplatin alone in adults with ATC by assessing the duration of progression-free survival (PFS); comparison of the response rates as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) will be an important secondary objective. We plan on biochemical and immunohistochemical analysis of several tumor parameters including mitotic index, expression of several proteins including epidermal growth factor receptor (EGFR), vascular endothelial growth factor receptor (VEGFR), BRAF, excision repair cross-complementation group 1 (ERCC1) and tumor protein p53 (TP53). Where sufficient tissue is available we will also perform gene expression analysis, micro ribonucleic acid (microRNA) array analysis, and compare these with 3-deoxy-3 -\[(18)F\] fluorothymidine (FLT)-positron emission tomography (PET) and tumor growth rate constant. Eligibility: Phase I: adults age 18 and older with
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Crolibulin
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2011-01-26 |
| Est. Completion | 2016-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01240590
The ClinicalTrials.gov registry entry for NCT01240590 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Solid Tumor appearing as the primary indexed condition, and to 2 interventions — of which Cisplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01240590 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01240590 about?
NCT01240590 is a clinical study titled "A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC)". Background: Anaplastic thyroid cancer (ATC) is one of the most aggressive of all solid tumors; chemotherapy and surgery have had no impact on local control or survival of patients, with a median survival of 3-7 months. Crolibulin (EPC2407) is a microtubulin inhibitor that has been shown to have di...
What is the current status of trial NCT01240590?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2011-01-26. Estimated completion is 2016-12-31.
What conditions does trial NCT01240590 study?
This clinical trial studies the following conditions: Solid Tumor, Anaplastic Thyroid Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01240590?
The interventions under investigation include: Cisplatin (DRUG), Crolibulin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01240590?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01240590 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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