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Report for Clinical Trial NCT03217669

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase I Study of Epacadostat (INCB24360) in Combination With Sirolimus in Advanced Malignancy

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).

NCT03217669 Advanced Solid Tumor Non-small Cell Lung Cancer (NSCLC)
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

2 Interventions

Name: Epacadostat

Description: Epacadostat tablet: 100mg or 300mg
Type: Drug
Group Labels: 2

Sirolimus/Epacadostat Dose Escalation Sirolimus/Epacadostat Dose Expansion

Name: sirolimus

Description: Sirolimus tablet: 1mg, 2mg, 3mg, or 6mg
Type: Drug
Group Labels: 2

Sirolimus/Epacadostat Dose Escalation Sirolimus/Epacadostat Dose Expansion


Primary Outcomes

Description: Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 will be used to measure incidence of treatment-emergent adverse events.

Measure: Incidence of treatment-emergent adverse events.

Time: 28 days

Secondary Outcomes

Description: Subjects will be assessed every 8 weeks by radiologic imaging to monitor disease status.

Measure: Overall response response in subjects with NSCLC (dose expansion cohort)

Time: up to 12 months

Description: Subjects will be assessed at Week 8 by radiologic imaging to monitor disease status.

Measure: Disease control rate (DCR) >40% in subjects with NSCLC (dose expansion cohort)

Time: 2 months

Description: Subjects will be assessed every 8 weeks by radiologic imaging to monitor disease status.

Measure: Median progression free survival (mPFS) >3 months in subjects with NSCLC (dose expansion cohort)

Time: up to 12 months

Description: Subjects will be assessed every 8 weeks by radiologic imaging to monitor disease status.

Measure: Median Overall Survival (mOS) > 6 months in subjects with NSCLC (dose expansion cohort)

Time: up to 12 months

Purpose: Treatment

Allocation: Non-Randomized

Sequential Assignment


There is one SNP

SNPs


1 T790M

- Dose escalation: subjects with advanced and unresectable solid tumor who progressed on at least one line of systemic therapy, and no approved therapy or standard therapy with demonstrated clinical benefit exists; and all subjects with T790M mutation positive NSCLC have progressed on osimertinib. --- T790M ---



HPO Nodes


HPO: