A Window of Opportunity Study to Investigate Mechanisms o... | NCT03471286

ID	Type	Description	Link
IRB00156271	Other Identifier	JHM IRB
I-24360-17-13	Other Identifier	Incyte Corporation

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Deprioritization of drug in this patient population

Expanded Access Info

Start Date

Jun 6, 2019Actual

Primary Completion Date

Jul 30, 2021Actual

Completion Date

Jul 30, 2021Actual

First Submitted Date

Mar 2, 2018

First Submission Date that Met QC Criteria

Mar 19, 2018

First Posted Date

Mar 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2021

Last Update Posted Date

Aug 26, 2021Actual

Name	Class
Incyte Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a single-institution, single arm, open label, window of opportunity clinical trial that will act as a Master Protocol with a primary objective to assess pharmacodynamic effects of the novel study drugs in subjects with resectable solid tumor malignancies.

Each Sub-protocol conducted under the Master Protocol will evaluate different novel therapeutic agent(s).

Estimated enrollment is 15 subjects per Sub-Protocol.

Detailed Description

Patients will have a short-course (4-weeks) administration of a given compound in the timeframe between the diagnostic biopsy and the surgical resection. A pre-treatment tumor biopsy will be obtained, and blood samples will be collected before, during, and at the end of treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sub-Protocol A	Experimental	Epacadostat	Drug: Epacadostat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Epacadostat	Drug	Drug is taken orally two times per day for 14 days, prior to surgical resection of tumor.	Sub-Protocol A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacodynamic effects as measured by changes in biomarkers in pre- and post-dose tumor and blood specimens	To establish baseline levels and measure pharmacodynamic biomarker changes in tumor and/or blood samples after treatment with the study drug. Sub- Protocol A will focus on changes in CD8+ T cells, CD4+Foxp3+ cells, NK cells, DCs and immune checkpoints.	Approximately 1 year

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability as measured by incidence of AEs (Adverse Events)	To assess the safety and tolerability of the study drug in the pre-surgical setting graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.	Approximately 1 year
Pathological Response Rate as measured by correlation of biomarkers in tumor and/or blood specimens

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must have biopsy-proven solid tumor that is eligible for elective surgical resection, disease does not require immediate therapy, and there is NO approved/ standard therapy available that is shown to prolong overall survival.
ECOG performance status of 0 or 1.
Must have a tumor lesion that is amenable to biopsy, and willing to undergo biopsy.
Willing to provide tissue and blood samples for research.

Exclusion Criteria:

The following solid tumors are NOT eligible: Primary brain tumor, Ocular melanoma, Head and neck cancer, Breast cancer, Prostate cancer, Testicular cancer, and Stage III rectal cancer.
Any active malignancy within 3 years prior, except: Adequately treated basal cell or squamous cell skin cancer, or early stage cancers (carcinoma in situ or stage 1) treated with curative intent.
Any uncontrolled intercurrent illness, including but not limited to: Symptomatic congestive heart failure, Unstable angina pectoris or coronary angioplasty or stenting within 6 months prior to enrollment, Cardiac arrhythmia, Psychiatric illness or social situations that would limit compliance with study requirements, or Ongoing or active infection.
Any known sensitivity to or history of allergic reaction to compounds of similar chemical or biological composition of study drug(s).
Unwilling or unable to follow the study schedule.

Other protocol defined inclusion/exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Nilofer Azad, MD	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins		Baltimore	Maryland	21231	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided