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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Adenocarcinoma
• Intervention / Treatment: Drug: Personalised treatment; Drug: Treatment chosen per investigator´s judge

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: Interventional
• Enrollment (Anticipated): 146
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario de La Paz
  • Zaragoza, Spain, 50009
    • Hospital Miguel Servet
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28942
      • Hospital Universitario de Fuenlabrada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year overall survival	Efficacy. 1-year overall survival	1-year overall survival

Collaborators and Investigators

• Sponsor: Hospital Universitario de Fuenlabrada
• Investigators: Principal Investigator: Manuel Hidalgo, PhD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: June 1, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Metastatic; Pancreas
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: 2015-004860-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided