Clinical trial NCT02795650: Personalised Therapy for Metastatic ADPC Determined by Genetic Testing and Avatar Model Generation
Official title: Personalised Therapy for Patients With Metastatic Adenocarcinoma of the Pancreas Determined by Genetic Testing and Avatar Model Generation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Adenocarcinoma
Keywords: Metastatic
Pancreas
Lead sponsor: Hospital Universitario de Fuenlabrada
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 1-year overall survival
timeFrame: 1-year overall survival
Secondary outcomes:
Other outcomes:
Locations:
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario de la Paz
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Manuel Hidalgo, PhD
role: PRINCIPAL_INVESTIGATOR
References: