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

Phase 2

• Conditions: Adenocarcinoma
• Interventions: Drug: Personalised treatment; Drug: Treatment chosen per investigator´s judge

• Registration Number: NCT02795650
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-10
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-26
• Primary Completion: 2021-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 146

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Personalised treatment	Personalised treatment will be chosen for patients based on the results of tumor sequencing, bioinformatics and avatar model drug testing.
Control	Treatment chosen per investigator´s judge	Investigators are allowed to chose the best option of standard treatment for patients.

Primary Outcome Measures

Name	Time	Method
1-year overall survival	1-year overall survival	Efficacy. 1-year overall survival

Trial Locations

Locations (5)

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario de Fuenlabrada; 🇪🇸 Fuenlabrada, Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Universitario de la Paz; 🇪🇸 Madrid, Spain