NCT02795650

Personalised Therapy for Metastatic ADPC Determined by Genetic Testing and Avatar Model Generation

Personalised Therapy for Patients With Metastatic Adenocarcinoma of the Pancreas Determined by Genetic Testing and Avatar Model Generation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Hospital Universitario de Fuenlabrada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open label, randomised phase II clinical trial for patients with metastatic adenocarcinoma of the pancreas. Patients randomised to the experimental arm will undergone tumoral biopsy before starting first line of treatment and will be administered personalised therapy as second or third line.

Detailed description

This is a multicenter, open label, randomised phase II clinical trial for patients with metastatic adenocarcinoma of the pancreas. Patients with metastatic disease will be randomised to the experimental or control arms. Those in the experimental arm will undergone a tumoral biopsy in order to perform exome sequencing, bioinformatic report, and avatar mouse models for drug testing. This information will allow the expertise panel to elaborate a treatment recommendation as second or third lines of treatment. Patients in the control arm will receive treatment as per investigator´s judge. The main objective of the trial is to determine whether personalised treatments achieve improved 1-year overall survival.

Conditions

• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Personalised treatment	Personalised treatments include chemotherapy, targeted therapy, immunotherapy or others based on the previous test results, chosen from a database that include more than 2000 different drugs.
DRUG	Treatment chosen per investigator´s judge	Investigators are allowed to chose what they consider the best standard treatment option for their patients.

Timeline

• Start date: 2016-05-01
• Primary completion: 2021-09-01
• Completion: 2022-09-01
• First posted: 2016-06-10
• Last updated: 2021-02-26

Locations

5 sites across 1 country: Spain