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NCT01240590 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC)
A Phase 1 study of Solid Tumor and Anaplastic Thyroid Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT01240590: Completed Phase 1 study of Solid Tumor and Anaplastic Thyroid Cancer, sponsored by National Cancer Institute (NCI).
NCT01240590 is a Phase 1 study of Solid Tumor and Anaplastic Thyroid Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 222-participant average among 196 other Solid Tumor trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01240590, a Phase 1 study of Solid Tumor and Anaplastic Thyroid Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
MTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE).
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 |
What the finished NCT01240590 record still lists
NCT01240590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 222-participant average among 196 other Solid Tumor trials with a reported enrollment target (88% lower).
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.
NCT01240590 reports a single indexed study location in Maryland.
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.
What interventions are being tested in trial NCT01240590?
The interventions under investigation include: Cisplatin (DRUG), Crolibulin (DRUG).
Who is sponsoring clinical trial NCT01240590?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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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 NCT01240590's enrollment target sits among peer trials
27 165th of 196 higher than 32 of 196 other Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor 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.
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