Phase I-II trial of gemcitabine plus nab-paclitaxel (GemBrax) followed by FOLFIRINOX as first-line treatment of patients with metastatic pancreatic adenocarcinoma - GABRINOX

Phase 1

• Conditions: metastatic pancreatic adenocarcinoma; MedDRA version: 16.0Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003678-13-FR
• Lead Sponsor: Institut Régional de Cancerologie de Montpellier - Val d’Aurelle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-31
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

1.Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the radiologic data.
2.Initial diagnosis of metastatic disease must have occurred =6 weeks prior to inclusion in the study.
3.One or more measurable metastatic lesions (Recist 1.1) by CT scan of the abdomen, pelvis and chest, or hepatic MRI and CT scan (abdomen, pelvis and chest) without injection, if patient is allergic to CT contrast media).
4.No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
5.Prior treatment with 5 FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided that at least 6 months have relapsed since completion of the last dose and no lingering toxicities are present.
6.Eastern Cooperative Oncology Group (ECOG) performance status of = 1.
7.Males or females aged 18 to 75 years at the time of signing the Informed Consent Form (ICF).
8.Adequate blood function at baseline (obtained within 14 days before start of study treatment) as defined by :
•Absolute neutrophil count (ANC) = 1.5 × 10^9/L;
•Platelets count = 100,000/mm3 (100 × 10^9/L);
•Hemoglobin (Hgb) = 9 g/dL.
9.Adequate liver and renal function at baseline (obtained within 14 days before start of study treatment) as defined by :
•AST and ALT = 2.5 x upper limit of normal range (ULN), unless liver metastases are clearly present in which case AST and ALT = 5 × ULN is allowed;
•Total bilirubin = 1.5 x ULN;
•Serum creatinine within normal limits or calculated clearance = 60mL/min for patients with serum creatinine levels above or below the institutional normal value (using the Cockroft-Gault formula).
10.Patient has no clinical significant abnormalities in urinalysis results (obtained = 14 days before start of study treatment)
11.Patient has acceptable coagulation values (obtained =14 days prior to the first administration of study drug) as demonstrated by :
•Prothrombin time (PT) within normal limits (± 15%)
•Partial thromboplastin time (PTT) within normal limits (± 15%)
12.Patient should be asymptomatic for jaundice prior to the first administration of study drug (Day1). Significant or symptomatic amounts of ascites should be drained prior to Day 1.
13.Pain symptoms should be stable and should not require modifications in analgesic management prior to Day 1 of treatment.
14.Life expectancy = 2 months
15.Non-pregnant and non-lactating female. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (ß-hCG) documented 72 hours prior to randomization.
16.If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drug. In addition, male and female patients must utilize contraception after the end of treatment as recommended in the product's Summary of Product Characteristics or Prescribing Information provided in the study manual.
17.Informed consent signed prior to any study specific procedures.
18.Affiliated to the French National social security
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 6

Exclusion Criteria

1.Known brain metastases.
2.Patient has only locally advanced disease.
3.History of other malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
4.Patients having received cytotoxic doses of any other chemotherapy (than 5FU and gemcitabine) in the adjuvant setting.
5.Peripheral sensory neuropathy = grade 2 at the time of signing the ICF.
6.Patients using AVKs (Coumadin…)
7.Active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
8.Known historical or active infection with HIV
9.Major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
10.History of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the SmPCs or Prescribing Information.
11.History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).
12.Patients with high cardiovascular risk, including, but not limited to, coronary stenting or myocardial infarction in the past year.
13.History of Peripheral Artery Disease (e.g. claudication, Leo Buerger's disease).
14.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.
15.Enrollment in any other clinical protocol within 4 weeks of signing the ICF.
16.Patient is unwilling or unable to comply with study procedures, or is planning to take vacation for 7 or more consecutive days during the course of the study.
17.Legal incapacity or limited legal capacity. Medical or psychological conditions not allowing the subject to complete the study or sign the consent.

Study & Design

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