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

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ClinicalTrials.gov Identifier: NCT03471286
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.


Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Epacadostat Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Arm Intervention/treatment
Experimental: Sub-Protocol A
Epacadostat
Drug: Epacadostat
Drug is taken orally two times per day for 28 days, prior to surgical resection of tumor.




Primary Outcome Measures :
  1. Pharmacodynamic effects as measured by changes in biomarkers in pre- and post-dose tumor and blood specimens [ Time Frame: Approximately 1 year ]

    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.



Secondary Outcome Measures :
  1. Safety and tolerability as measured by incidence of AEs (Adverse Events) [ Time Frame: Approximately 1 year ]
    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.

  2. Pathological Response Rate as measured by correlation of biomarkers in tumor and/or blood specimens [ Time Frame: Approximately 1 year ]
    To evaluate pathological response rate of solid tumor malignancies in subjects receiving neo-adjuvant treatment with the study drug and to assess a possible correlation with biomarkers either in the tumor specimens either in the bloods samples and the pathological response.

  3. Overall Survival [ Time Frame: Approximately 2 years ]
    To determine the overall survival (OS) status of subject treated which the study drug at 6 months, 1 year and 2 year



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. ECOG performance status of 0 or 1.
  3. Must have a tumor lesion that is amenable to biopsy, and willing to undergo biopsy.
  4. Willing to provide tissue and blood samples for research.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Any known sensitivity to or history of allergic reaction to compounds of similar chemical or biological composition of study drug(s).
  5. Unwilling or unable to follow the study schedule.

Other protocol defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471286


Contacts
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Contact: Denise Gallagher, RN 410-502-5140 phase1trials@jhmi.edu

Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Incyte Corporation
Investigators
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Principal Investigator: Nilofer Azad, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03471286     History of Changes
Other Study ID Numbers: J17168
IRB00156271 ( Other Identifier: JHM IRB )
I-24360-17-13 ( Other Identifier: Incyte Corporation )
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms