A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies

NCT03471286 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: J17168IRB00156271I-24360-17-13
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Safety and tolerability as measured by incidence of AEs (Adverse Events)

  Approximately 1 year

• Pathological Response Rate as measured by correlation of biomarkers in tumor and/or blood specimens

  Approximately 1 year

• Overall Survival

  Approximately 2 years

Study Arms (1)

Sub-Protocol A

EXPERIMENTAL

Epacadostat

Drug: Epacadostat

Interventions

Epacadostat DRUG

Drug is taken orally two times per day for 14 days, prior to surgical resection of tumor.

Sub-Protocol A

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Incyte Corporation: collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Interventions

epacadostat

Study Officials

• Nilofer Azad, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 20, 2018
• Study Start: June 6, 2019
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)