FindMyKOL
Clinical trialNCT02010567TerminatedPhase 1/PHASE2Interventional

Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer

SponsorUNC Lineberger Comprehensive Cancer CenterEnrollment32Rectal Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Rocky Mountain Cancer Center

    Denver, Colorado, United States

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana, United States

  • University of North Carolina

    Chapel Hill, North Carolina, United States

  • Rex Cancer Center at Rex Hospital

    Raleigh, North Carolina, United States

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, United States

  • Swedish Cancer Institute

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

CRLX101Capecitabine →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Dec 2013
Primary completion
16 Sept 2016
Completion
25 Jun 2019
Last update posted
3 Nov 2020
Registered enrollment
32
Registry id
NCT02010567
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.