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BrUOG 302:BYL719, Capecitabine and Radiation for Rectal Cancer: A Brown University Oncology Research Group Study

NCT02550743 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-03-12

Study results available
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Summary

The primary goal of this Brown University Oncology Research Group is to determine that a safe dose of BYL719 can be administered with capecitabine and radiation in patients with rectal cancer. Therefore, the threshold of success for this phase I study is to establish safety.

Conditions

Interventions

DRUG

BYL719

DRUG

Capecitabine

RADIATION

Radiation

Sponsors & Collaborators

  • Brown University

    collaborator OTHER

  • Lifespan

    collaborator OTHER

  • Novartis Pharmaceuticals Corporation (Financial supporter)

    collaborator UNKNOWN

  • howard safran

    lead OTHER

Principal Investigators

  • Howard Safran, MD · BrUOG Study Chair

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-03
Primary Completion
2018-11-16
Completion
2018-11-16

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02550743 on ClinicalTrials.gov