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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 : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario de Fuenlabrada

Tracking Information
First Submitted Date  ICMJE June 1, 2016
First Posted Date  ICMJE June 10, 2016
Last Update Posted Date March 31, 2020
Actual Study Start Date  ICMJE May 2016
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
1-year overall survival [ Time Frame: 1-year overall survival ]
Efficacy. 1-year overall survival
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
1-year overall survival [ Time Frame: 1-year overall survival ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Personalised Therapy for Metastatic ADPC Determined by Genetic Testing and Avatar Model Generation
Official Title  ICMJE Personalised Therapy for Patients With Metastatic Adenocarcinoma of the Pancreas Determined by Genetic Testing and Avatar Model Generation
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adenocarcinoma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Experimental arm
    Personalised treatment will be chosen for patients based on the results of tumor sequencing, bioinformatics and avatar model drug testing.
    Intervention: Drug: Personalised treatment
  • Active Comparator: Control
    Investigators are allowed to chose the best option of standard treatment for patients.
    Intervention: Drug: Treatment chosen per investigator´s judge
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
146
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02795650
Other Study ID Numbers  ICMJE 2015-004860-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hospital Universitario de Fuenlabrada
Study Sponsor  ICMJE Hospital Universitario de Fuenlabrada
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manuel Hidalgo, PhD Beth Israel Deaconess Medical Center
PRS Account Hospital Universitario de Fuenlabrada
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP