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NCT02010567 · ClinicalTrials.gov registry record · Phase 1
Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer
A Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT02010567 is a Phase 1 study that was terminated before completion, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 32 participants.
The verdict
NCT02010567, a Phase 1 study, was terminated before completion, sponsored by UNC Lineberger Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This trial will enroll patients with locally advanced rectal cancer (resectable and non-resectable).The phase Ib dose escalation portion of trial is designed to determine the maximum tolerated dose (MTD) of CRLX101 when combined with standard neoadjuvant therapies capecitabine (Cape) and radiation therapy (XRT). CRLX101 is a nanopharmaceutical (NP) formulation of camptothecin. These results will determine the recommended phase II dose (RP2D) for CRLX101 in this setting. The phase II portion of the trial is designed to evaluate the efficacy and safety of CRLX101 at the RP2D, when combined with capecitabine and radiation therapy prior to surgery.
Interventions
- DRUG Capecitabine
- RADIATION Radiotherapy
- PROCEDURE Surgery
- DRUG CRLX101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2013-12 |
| Est. Completion | 2019-06-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02010567
The ClinicalTrials.gov registry entry for NCT02010567 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Capecitabine is the first listed.
NCT02010567 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02010567 about?
NCT02010567 is a clinical study titled "Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer". This trial will enroll patients with locally advanced rectal cancer (resectable and non-resectable).The phase Ib dose escalation portion of trial is designed to determine the maximum tolerated dose (MTD) of CRLX101 when combined with standard neoadjuvant therapies capecitabine (Cape) and radiation t...
What is the current status of trial NCT02010567?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2013-12. Estimated completion is 2019-06-25.
What interventions are being tested in trial NCT02010567?
The interventions under investigation include: Capecitabine (DRUG), Radiotherapy (RADIATION), Surgery (PROCEDURE), CRLX101 (DRUG).
Who is sponsoring clinical trial NCT02010567?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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