Integrated Genomics and Avatar Mouse Models for Personalized Treatment of Pancreatic Cancer

• Conditions: Metastatic pancreatic cancer; MedDRA version: 18.1Level: PTClassification code 10033610Term: Pancreatic carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004860-12-ES
• Lead Sponsor: Centro Nacional Investigaciones Oncológicas (CNIO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-17
• Last Update Posted: 25 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who are 18 years or older;
2. Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
3. One or more metastatic tumor sites that are amenable for biopsy.
4. Measurable or evaluable disease.
5. Patients must have received either no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease or be within the first 3 cycles of first line chemotherapy. Palliative radiotherapy for bone metastasis is allowed.
6. Adequate blood counts at baseline (obtained <=14 days prior to randomization):
- Absolute neutrophil count (ANC) >= 1.5 × 109/L;
- Platelet count >= 100,000/mm3 (100 × 109/L);
- Hemoglobin (Hgb) >= 9 g/dL.
7. Patient has the following blood chemistry levels at baseline:
- AST (SGOT), ALT (SGPT) <= 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then <= 5 × ULN is allowed
- Total bilirubin <= 1.5 x ULN
- Total albumin >= 0.75 ULN
- Serum creatinine <= 1.5 x ULN
8. Eastern Cooperative Oncology Group (ECOG) performance score of 1 or lower.
9. Written informed consent.
10. Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use two medically acceptable methods of contraception during the study and for 4 months after the last study treatment intake for women and 6 months for men.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion Criteria

1. Known brain metastases, unless previously treated and well-controlled for at least 3 months.
2. Only locally advanced disease.
3. History of malignancy in the last 5 years.
4. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
5. Contraindication for performing a tumor biopsy.
6. Known historical or active infection with HIV, hepatitis B, or hepatitis C.
7. High cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year.
8. Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
9. Female patient is pregnant or breast-feeding.
10. Unwilling or unable to comply with study procedures. The patients must be agreeable to performing a tumor biopsy if allocated to the interventional arm.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of implementing an integrated genetics and avatar mouse model personalized treatment strategy to the conventional treatment strategy in patients with metastatic PDAC;Secondary Objective: - To compare the response rates, progression-free survival and CA 19.9 tumor marker modulation effects of patients with metastatic pancreatic cancer treated with a personalized approach to the conventional treatment strategy.<br>- To determine the genomic landscape of metastatic PDAC.<br>- To generate Avatar mouse models from metastatic PDAC.<br>- To develop customized disease monitoring based on mutation analysis in extracellular circulating DNA and circulating exosomes.<br>- To attempt generating Avatar models from circulating tumor cells.;Primary end point(s): One year survival rate.;Timepoint(s) of evaluation of this end point: 1 year

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Objective tumor response<br>- Progression-free survival <br>- CA 19.9 tumor measurements<br>- Determine whether a correlation exists between mutation analysis in extracellular circulating DNA and efficacy outcomes;Timepoint(s) of evaluation of this end point: Every 8-12 weeks