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Epacadostat (INCB24360) in Combination With Sirolimus in Advanced Malignancy

NCT03217669 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-05-03

No results posted yet for this study

Summary

This is a small phase I study with dose escalation and dose expansion cohorts. The former cohort will need up to 12 subjects with advanced solid tumor to define feasibility and recommended phase 2 dose (RP2D); the latter up to 10 subjects to further define safety. Study subjects will be adults with advanced solid tumor (dose escalation) and advanced non-small cell lung cancer (NSCLC) who progressed on at least one first-line systemic therapy (dose expansion).

Conditions

  • Advanced Solid Tumor
  • Non-small Cell Lung Cancer (NSCLC)

Interventions

DRUG

Epacadostat

Epacadostat tablet: 100mg or 300mg

DRUG

sirolimus

Sirolimus tablet: 1mg, 2mg, 3mg, or 6mg

Sponsors & Collaborators

  • University of Kansas Medical Center

    collaborator OTHER

  • Chao Huang

    lead OTHER

Principal Investigators

  • Chao Huang, MD · KUMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-22
Primary Completion
2024-04-01
Completion
2025-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03217669 on ClinicalTrials.gov