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PDR001 Plus Imatinib for Metastatic or Unresectable GIST

NCT03609424 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-01-03

No results posted yet for this study

Summary

Assuming that PDR001, an anti-PD-1 antibody, with imatinib might be effective in advanced GIST after failure of standard TKI therapies including imatinib, sunitinib, and regorafenib. In this phase I/II study of PDR001 plus imatinib, it is aimed to evaluate the safety and efficacy of this regimen as 4th line of treatment in advanced GIST.

Conditions

Interventions

DRUG

PDR001, Imatinib

-Phase Ib part : The standard 3+3 dose escalation scheme will be applied. DLTs will be evaluated during the first cycle (4 weeks). PDR001 400mg, every 4 weeks, IV Imatinib dose level -1 : 200mg, PO, QD Imatinib dose level 1 : 300mg, PO, QD Imatinib dose level 2 : 400mg, PO, QD -Phase II part * Recommended dose defined in phase Ib part will be tested

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Yoon-Koo Kang, MD, PhD · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-14
Primary Completion
2021-11-11
Completion
2021-11-11

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

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 NCT03609424 on ClinicalTrials.gov