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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
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario de Fuenlabrada

Brief 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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma Drug: Personalised treatment Drug: Treatment chosen per investigator´s judge Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 1-year overall survival [ Time Frame: 1-year overall survival ]
    Efficacy. 1-year overall survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas.
  • ECOG performance status 0 or 1
  • Age ≥ 18 years old.
  • Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control (oral contraceptives, intrauterine devices, or barrier methods used with a spermicide) for the duration of the study.
  • One or more sites of metastasis with one of the susceptible of biopsy.
  • Measurable or evaluable disease
  • No prior treatment with radiotherapy, surgery, chemotherapy or investigational treatment for the metastatic disease or no more than the three cycles of first line chemotherapy. Palliative radiotherapy for bone metastasis is allowed. Adjuvant or neoadjuvant radiotherapy or chemotherapy are allowed if they finished more that 6 months ago and the patient has no remaining toxicities.
  • Bone marrow function as follows, no more than 14 days prior to randomisation:

ANC > 1,500 cells/mm3 Platelets > 100,000 cells/mm3 Hemoglobin ≥9 g/dl

  • Adequate liver, renal and bone marrow functions.

    • AST (SGOT), ALT (SGPT) ≤ 2.5 × ULN and ≤ 5 x ULN if liver metastases.
    • Bilirubin ≤ 1,5 x ULN
    • Albumin total ≥ 0,75 ULN
    • Creatinine ≤ 1,5 x ULN
  • Ability to sign informed consent
  • Patients will be allowed to be randomised just once.

Exclusion Criteria:

  • Brain metastases, unless they have been previously treated and stable for 3 months at least (defined as no oedema, no need of steroids and stable disease in two CT scans separated by a minimum of 4 weeks).
  • Locally advanced disease.
  • Malignancies other than pancreatic cancer diagnosed within 5 years prior to randomization, except for adequately treated carcinoma in situ or basal or squamous cell skin cancer.
  • Bacterial, viral or fungal active infection that require systemic treatment.
  • Any contraindication for tumor biopsy.
  • Past or present HIV or hepatitis B or C infection.
  • Severe medical problems affecting organs or psychiatric illnesses that could interfere with the safety of the patient in the trial.
  • Pregnancy or breastfeeding women.
  • Patient will need to be informed and agree to undergo tumoral biopsy in the experimental arm.

Information from the National Library of Medicine

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


Contacts
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Contact: Sofía Perea, PhD (+34) 91 600 65 83 ercavatar@salud.madrid.org
Contact: Francesca Sarno, PhD (+34) 91 600 65 83 francesca.sarno@salud.madrid.org

Locations
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Spain
Hospital Universitario de Fuenlabrada Recruiting
Fuenlabrada, Madrid, Spain, 28942
Contact: Carolina Alonso    (+34) 91 600 65 83    capozo@salud.madrid.org   
Contact: Alonso         
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    carmenguillenponce@gmail.com   
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         
Sponsors and Collaborators
Hospital Universitario de Fuenlabrada
Investigators
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Principal Investigator: Manuel Hidalgo, PhD Beth Israel Deaconess Medical Center

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Responsible Party: Hospital Universitario de Fuenlabrada
ClinicalTrials.gov Identifier: NCT02795650    
Other Study ID Numbers: 2015-004860-12
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital Universitario de Fuenlabrada:
Metastatic
Pancreas
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancrelipase
Gastrointestinal Agents