Solid TumorPhase 1NCT03471286
A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies
A Phase 1 study testing Epacadostat in people with Solid Tumor, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Epacadostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2019to 30 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
About this study
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
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.
Read the 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.
- Conditions
- Solid Tumor
- Being tested
- Epacadostat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpacadostatDrug
Drug is taken orally two times per day for 14 days, prior to surgical resection of tumor.
| Study group | Role | What they receive |
|---|---|---|
| Sub-Protocol A | Experimental | Epacadostat Receives: Drug: Epacadostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 1 year
Secondary outcomes (3)
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.
Measured: Approximately 1 year
Pathological Response Rate as measured by correlation of biomarkers in tumor and/or blood specimens
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.
Measured: Approximately 1 year
Overall Survival
To determine the overall survival (OS) status of subject treated which the study drug at 6 months, 1 year and 2 year
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start6 Jun 2019
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Why it stopped: Deprioritization of drug in this patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- Nilofer Azad, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471286
- Sponsor's protocol ID
- J17168
- Other IDs
- IRB00156271, I-24360-17-13
- Status last verified
- Aug 2021
- First submitted
- 2 Mar 2018
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03471286
- Acronym / sponsor ID
- J17168
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Deprioritization of drug in this patient population
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sub-Protocol A | Experimental | Drug: EpacadostatEpacadostat |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpacadostatDrug is taken orally two times per day for 14 days, prior to surgical resection of tumor. | Drug | Sub-Protocol A |
Primary outcome
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.
3 secondary outcomes
Safety and tolerability as measured by incidence of AEs (Adverse Events)
Time frame: Approximately 1 year
Pathological Response Rate as measured by correlation of biomarkers in tumor and/or blood specimens
Time frame: Approximately 1 year
Overall Survival
Time frame: Approximately 2 years
Results and safety
The study was stopped early (reason given: Deprioritization of drug in this patient population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilofer Azad, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Epacadostat in people with Solid Tumor, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Deprioritization of drug in this patient population). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamic effects as measured by changes in biomarkers in pre- and post-dose tumor and blood specimens (time frame: Approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.