Personalised Therapy for Metastatic ADPC Determined by Genetic Testing and Avatar Model Generation (AVATAR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02795650|
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma||Drug: Personalised treatment Drug: Treatment chosen per investigator´s judge||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Personalised Therapy for Patients With Metastatic Adenocarcinoma of the Pancreas Determined by Genetic Testing and Avatar Model Generation|
|Actual Study Start Date :||May 2016|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2022|
Experimental: Experimental arm
Personalised treatment will be chosen for patients based on the results of tumor sequencing, bioinformatics and avatar model drug testing.
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.
Active Comparator: Control
Investigators are allowed to chose the best option of standard treatment for patients.
Drug: Treatment chosen per investigator´s judge
Investigators are allowed to chose what they consider the best standard treatment option for their patients.
- 1-year overall survival [ Time Frame: 1-year overall survival ]Efficacy. 1-year overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795650
|Contact: Sofía Perea, PhD||(+34) 91 600 65 email@example.com|
|Contact: Francesca Sarno, PhD||(+34) 91 600 65 firstname.lastname@example.org|
|Hospital Universitario de Fuenlabrada||Recruiting|
|Fuenlabrada, Madrid, Spain, 28942|
|Contact: Carolina Alonso (+34) 91 600 65 83 email@example.com|
|Principal Investigator: Laura Medina, Dr, PhD|
|Sub-Investigator: David Gutierrez, Dr, PhD|
|Sub-Investigator: Ignacio Juez, Dr, PhD|
|Hospital Universitario Ramón y Cajal||Recruiting|
|Madrid, Spain, 28034|
|Contact: Carmen Guillen +34913368263 firstname.lastname@example.org|
|Principal Investigator: Carmen Guillen|
|Hospital Universitario 12 de Octubre||Recruiting|
|Madrid, Spain, 28041|
|Contact: Rocio Garcia-Carbonero +34913908926|
|Principal Investigator: Rocio García-Carbonero|
|Hospital Universitario de la Paz||Recruiting|
|Madrid, Spain, 28046|
|Contact: Jaime Feliú +3497277516|
|Principal Investigator: Jaime Feliú|
|Hospital Miguel Servet||Recruiting|
|Zaragoza, Spain, 50009|
|Contact: Roberto Pazo +34976765500 ext 3825|
|Principal Investigator: Roberto Pazo|
|Principal Investigator:||Manuel Hidalgo, PhD||Beth Israel Deaconess Medical Center|