NCT03471286

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

A Phase 1b Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Epacadostat	Drug is taken orally two times per day for 14 days, prior to surgical resection of tumor.

Timeline

• Start date: 2019-06-06
• Primary completion: 2021-07-30
• Completion: 2021-07-30
• First posted: 2018-03-20
• Last updated: 2021-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study