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A Phase 1b Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients with Resectable Solid Tumor Malignancies
Protocol Number:
Phase I
Nilofer Azad
Johns Hopkins Kimmel Cancer Center in Baltimore
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).
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. Must have a tumor lesion that is amenable to biopsy, and willing to undergo biopsy. 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 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).
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.
Last Update
08/08/2020 05:02 AM