Exceptional Responders With Solid Tumor Cancer to Chemotherapy

Adera Labs

Status: Invitation-only

Conditions: Solid Tumor Neoplasms

Treatments: Drug: Standard of Care Chemotherapy

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02555735

ADRL-003

Details and patient eligibility

About

This is an observational study enrolling patients with Solid Tumor cancers to identify genomic expression differences between exceptional responders and non-responders to standard of care chemotherapy. Data analysis of the gene expression profile of the exceptional responders compared to non-responders will define genomic patterns that may help understand their response to chemotherapy.

Full description

This is an observational study of patients with solid tumor cancer to identify genomic expression differences obtained from their circulating tumor cells between exceptional responders and non-responders to standard of care chemotherapy. This study requires a 10 mL heparinized peripheral blood sample from each study participant at the time of enrollment to isolate, enrich and profile circulating tumor cells. Data analysis of the gene expression profile will define genomic patterns using Nearest Template Prediction for a predetermined panel of therapeutic agents based on standard of care. Chemotherapy selection is physician-choice. Information regarding disease progression will be gathered. Data analysis will be performed in study participants in the setting of ongoing disease progression.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological or cytological confirmation of solid tumor carcinoma.
• Patient is treatment-naïve or currently receiving chemotherapy.
• ECOG performance status (any).

Exclusion criteria

• HIV positive on antiretroviral therapy
• Pregnant or lactating
• Prior organ allograft
• Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment

Trial design

250 participants in 1 patient group

Solid Tumor Cancer

Description:

Participants with solid tumor cancer treated with physician-choice standard of care chemotherapy.

Treatment:

Drug: Standard of Care Chemotherapy