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

NCT02795650 | Unknown Phase 2 DMC

• 1 other identifier: 2015-004860-12
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 5

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.

Conditions

Adenocarcinoma

Keywords

Metastatic; Pancreas

Outcome Measures

Primary Outcomes (1)

• 1-year overall survival

  Efficacy. 1-year overall survival

  1-year overall survival

Study Arms (2)

Experimental arm

EXPERIMENTAL

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

Drug: Personalised treatment

Control

ACTIVE COMPARATOR

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

Drug: Treatment chosen per investigator´s judge

Interventions

Personalised treatment 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.

Experimental arm

Treatment chosen per investigator´s judge DRUG

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario de Fuenlabrada: lead

Study Sites (5)

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario de la Paz

Madrid, 28046, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (1)

• 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.

  PMID: 37081523 DERIVED

MeSH Terms

Conditions

Adenocarcinoma; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel Hidalgo, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 10, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

ES (5)