LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER MedDRA version: 20.0 Level: PT Classification code 10033609 Term: Pancreatic carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: RoActemra®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: GI1612
Other descriptive name: Recombin
Sponsors
Herlev & Gentofte Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent • Histological or cytological pancreatic adenocarcinoma. Malignant unspecified tumor cells in cytological specimen are allowed after investigator assessment, mixed histology including adenosquamous carcinoma is allowed • Male or non-pregnant, non-lactating females who are =18 years of age at the time of signing the informed consent form (ICF) • Unresectable locally advanced or metastatic pancreatic carcinoma • A modified Glasgow Prognostic Score (mGPS) criteria of 1 or 2 assessed within 14 days of randomization as defined below: -mGPS of 1: CRP > 10 mg/L and albumin = 35 g/L -mGPS of 2: CRP > 10 mg/L and albumin =65 years) yes F.1.3.1 Number of subjects for this age range 46
Exclusion criteria
Exclusion criteria: • Electrocardiogram (ECG) with significant modifications suggesting a high risk of occurrence of angina pectoris or high risk of arrhythmia. • Other malignancies, except adequately treated basal carcinoma or squamous cell carcinoma of the skin or in-situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score = 6, PSA < 0.5 ng/ml), or any other tumor with a disease free survival of = 5 years. • History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to: -Active infection requiring antibiotics within 2 weeks before the study inclusion -Concurrent congestive heart failure NYHA ( class III - IV ) -Unstable angina pectoris, or myocardial infarction within 6 months and/or prior poorly controlled hypertension -Inflammatory bowel disease (colitis, Crohns) or other serious gastrointestinal conditions associated with risk of perforation • Peripheral neuropathy grade = 2 according to CTCAE v 4.0 • Concomitant use of immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications. • No known or suspected allergy to the investigational agents or any agents given in association with this trial. • Pregnant or lactating women. • Any psychological, familial, sociological, or geographical condition which does not permit protocol compliance and medical follow-up. • Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare overall survival at 6 months of gemcitabine/nab-paclitaxel plus tocilizumab and gemcitabine/nab-paclitaxel. ;Secondary Objective: 1. To compare the efficacy, safety and quality of life of gemcitabine/nab-paclitaxel plus tocilizumab and gemcitabine/nab-paclitaxel. 2. To investigate whether circulating tumor KRAS mutations in in plasma are associated with disease outcome. 3. To assess whether IL-6 in plasma is correlated with clinical outcome and tocilizumab efficacy. 4. To assess whether inhibition of IL-6R has an impact on cachexia in patients with locally advanced or metastatic pancreatic cancer. ;Primary end point(s): Overall survival at 6 months. ;Timepoint(s) of evaluation of this end point: Time Frame: Approximately up to 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Performance status at 3 and 6 months, assessed by both investigator and patient 2) Progression free survival (PFS), defined as the time from the date of randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death due to any cause if sooner. [Time Frame: Randomization to disease progression, or death due to any cause if sooner. Approximately up to 6 months.] 3) Overall survival (OS), defined as the time from the date of randomization until death due to any cause. [Time Frame: Randomization until death due to any cause. Approximately up to 12 months.] 4) Overall response rate (ORR) (ORR = CR + PR). Objective response rate determined by radiographic disease assessments per RECIST 1.1, by investigator assessment. [Time Frame: Baseline through end of study. Approximately up to 6 months.] 5) Disease control rate (DCR), (DCR = CR + PR + SD), according to RECIST 1.1. 6) Safety (Data on safety parameters) Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments. [Time Frame: Baseline through approximately 30 days post treatment discontinuation. Approximately up to 6 months.] 7) Quality of Life (Quality of Life Questionnaire C30 (QLQ-C30) Version 3.0). Exploratory 1) Identification of circulating tumor KRAS mutations in plasma 2) Assessing of plasma IL-6 3) Measure effects on body composition and plasma markers of inflammation/cachexia, and compare with tumor response, quality of life, and survival;Timepoint(s) of evaluation of this end point: Time Frame: Approximately up to 6 months. | — |
Countries
Denmark, Norway
Contacts
Public ContactInna Chen
Herlev & Gentofte Hospital
Outcome results
None listed