Clinical trial NCT03471286: A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Incyte Corporation
First posted: 2018-03-20
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Pharmacodynamic effects as measured by changes in biomarkers in pre- and post-dose tumor and blood specimens
timeFrame: Approximately 1 year
Secondary outcomes:
measure: Safety and tolerability as measured by incidence of AEs (Adverse Events)
timeFrame: Approximately 1 year
measure: Pathological Response Rate as measured by correlation of biomarkers in tumor and/or blood specimens
timeFrame: Approximately 1 year
measure: Overall Survival
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Nilofer Azad, MD
role: PRINCIPAL_INVESTIGATOR
References: