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A Phase lb/ll, Open Label, Single Arm Study With Olinvacimab and Capecitabine in mCRC Patients (OLCAP)

NCT04751955 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-10-31

No results posted yet for this study

Summary

The aim on this study is to assess the safety and efficacy of the anti-VEGFR2 monoclonal antibody olinvacimab and the capecitabine in patients with metastatic colorectal carcinoma who failed two prior chemotherapies

Conditions

  • Colorectal Cancer Metastatic

Interventions

DRUG

Olinvacimab added to Capecitabine

Olinvacimab: IV weekly administration In phase lb, 12mg/kg and 16mg/kg weekly IV will be tested. In phase ll, the RP2D in phase lb will be used. Capecitabine: fixed dose as an oral administration, 1250mg/m2 BID on day 1 to 14 followed by 7 days off

Sponsors & Collaborators

  • Korean Cancer Study Group

    lead OTHER

Principal Investigators

  • Soohyeon Lee, MD, PhD · Korea Cancer Study Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-10-31
Completion
2024-08-31

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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 NCT04751955 on ClinicalTrials.gov