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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: Clinical Trial Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MTD is the highest dose of CRLX101 at which ≤1 out of 6 patients had a dose limiting toxicity (DLT) using CTCAE v4.0 toxicity criteria. DLTs include Grade (G) \>3 neutropenia for ≥7 days; G 3 or 4 neutropenia with fever; G 4 anemia not related to cancer-associated bleeding; G 4 thrombocytopenia or G 3 with clinically significant bleeding; G ≥3 nausea or vomiting \>48 hours despite anti-emetics; G 2 cystitis not resolved within 14 days; second G 2 cystitis; G 3 or 4 cystitis; diarrhea requiri
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 |
Why NCT02010567 stopped before completion
NCT02010567 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 4 interventions - of which Capecitabine is the first listed.
NCT02010567 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02010567's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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