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

NCT ID: NCT02795650

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2022-09-30

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.

Conditions

Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental arm

Personalised treatment will be chosen for patients based on the results of tumor sequencing, bioinformatics and avatar model drug testing.

Group Type: EXPERIMENTAL

Personalised treatment

Intervention Type: DRUG

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.

Control

Investigators are allowed to chose the best option of standard treatment for patients.

Group Type: ACTIVE_COMPARATOR

Treatment chosen per investigator´s judge

Intervention Type: DRUG

Investigators are allowed to chose what they consider the best standard treatment option for their patients.

Interventions

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.

Intervention Type: DRUG

Treatment chosen per investigator´s judge

Investigators are allowed to chose what they consider the best standard treatment option for their patients.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario de Fuenlabrada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manuel Hidalgo, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario de la Paz

Madrid, , Spain

Hospital Miguel Servet

Zaragoza, , Spain

Countries

Spain

References

Huebner A, Black JRM, Sarno F, Pazo R, Juez I, Medina L, Garcia-Carbonero R, Guillen C, Feliu J, Alonso C, Arenillas C, Moreno-Cardenas AB, Verdaguer H, Macarulla T, Hidalgo M, McGranahan N, Toledo RA. ACT-Discover: identifying karyotype heterogeneity in pancreatic cancer evolution using ctDNA. Genome Med. 2023 Apr 20;15(1):27. doi: 10.1186/s13073-023-01171-w.

Reference Type: DERIVED

PMID: 37081523 (View on PubMed)

Other Identifiers

2015-004860-12

Identifier Type: -

Identifier Source: org_study_id