E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inoperable locally advanced pancreatic cancer. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033606 |
E.1.2 | Term | Pancreatic cancer non-resectable |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Phase I part To determine the recommended safe dosing for the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer.
Phase II part 1) To investigate the proportion of patients with inoperable locally advanced pancreatic cancer receiving chemoradiation with gemcitabine plus panitumumab as first line treatment, that is progression-free at 7 months.
2) To evaluate the safety and tolerability for the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer.
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E.2.2 | Secondary objectives of the trial |
1) To assess early signs of clinical activity of the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer. 2) To assess the clinical response rate of the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer. 3) To assess time-to-progression (TTP) and overall survival amongst patients with inoperable locally advanced pancreatic cancer receiving chemoradiation with gemcitabine plus panitumumab as first line treatment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histological or cytological confirmed pancreatic cancer. 2. Not eligible for curative resection. 3. No distant metastases present. 4. Previously untreated with chemotherapy and anti-cancer biologicals for current malignancy. 5. No other current malignant disease, except for basal cell carcinoma of the skin. 6. Measurable or evaluable disease as defined by RECIST 1.1 criteria. 7. Performance status 0–2 Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Scale. 8. Age ≥ 18 years. 9. Adequate haematological and biological functions: • Bone marrow function: a. Neutrophils ≥ 1.5 x 109/L b. Platelets ≥ 100 x 109/L c. Hb ≥ 6 mmol/L • Hepatic function: a. AST/ALT and alkaline phosphatase (ALP) ≤ 2.5 x institutional upper limit of normal (ULN) b. Bilirubin ≤ 1.5 times institutional ULN • Renal function: eGFR >50ml/min • Metabolic Function: a. Magnesium ≥ lower limit of normal b. Calcium ≥ lower limit of normal. 10. No imminent bowel obstruction. 11. No active bleeding. 12. No uncontrolled infection. 13. Patients with reproductive potential must use effective contraception. Female patients must have a negative pregnancy test. 14. Signed informed consent.
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E.4 | Principal exclusion criteria |
1. Participation in another therapeutic clinical study within 30 days of enrollment or during this clinical study. 2. No adequate radiation therapy possible: based on the opinion of the radiation oncologist when radiation therapy cannot be performed because radiation field is too large (PTV volume too large or OAR too high) 3. History of allergic reactions to gemcitabine or antibody treatment. 4. Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection, uncontrolled hypertension). 5. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 1 year before enrolment/randomization 6. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. 7. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance. 8. Pregnant or breastfeeding women. 9. Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for six months after last treatment. 10. Known positive status for HIV and/or hepatitis B or C. 11. Any reason why, in the investigator’s opinion, the patient should not participate in the study. 12. Drug or alcohol abuse.
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E.5 End points |
E.5.1 | Primary end point(s) |
Phase I 1 The recommended safe dosing for the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer.
Phase II 1) The proportion of patients with inoperable locally advanced pancreatic cancer receiving chemoradiation with gemcitabine plus panitumumab as first line treatment, that is alive and progression-free at 7 months. 2) The safety and tolerability for the combination of chemoradiation with gemcitabine, plus panitumumab in patients with inoperable locally advanced pancreatic cancer.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |