Status:
TERMINATED
A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Incyte Corporation
Conditions:
Solid Tumor
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
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 st...
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03471286
Start Date
June 6 2019
End Date
July 30 2021
Last Update
August 26 2021
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231