A Controlled, Randomized, Open label Phase II Trial to Evaluate Safety and Efficacy of a 1st line Combination Treatment with Weekly Infusion of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG®-1) in Three Dose Levels Compared with Gemcitabine Monotherapy in Patients with Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas - N/A

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-000666-39-HU
• Date of registration: 05/12/2005
• Prospective Registration: Yes
• Primary sponsor: MediGene AG
• Public title: A Controlled, Randomized, Open label Phase II Trial to Evaluate Safety and Efficacy of a 1st line Combination Treatment with Weekly Infusion of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG®-1) in Three Dose Levels Compared with Gemcitabine Monotherapy in Patients with Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas - N/A
• Scientific title: A Controlled, Randomized, Open label Phase II Trial to Evaluate Safety and Efficacy of a 1st line Combination Treatment with Weekly Infusion of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG®-1) in Three Dose Levels Compared with Gemcitabine Monotherapy in Patients with Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas - N/A
• Date of first enrolment: 26/01/2006
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000666-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Czech Republic, Germany, Hungary, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
- Written informed consent
- histologically confirmed pancreatic adenocarcinoma suitable for chemotherapy
- clinical diagnosis of irresectable pancreatic adenocarcinoma
- ECOG performance status 0, 1 or 2
- = 18 years old
- negative pregnancy test (females of childbearing potential)
- willingness to perform double-barrier contraception during study and for 6 months post chemotherapy treatment
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Cardiovascular disease, New York Heart Association (NYHA) III or IV
- History of severe supraventricular or ventricular arrhythmia
- History of coagulation or bleeding disorder (PTT > 1.5 x ULN)
- Severe pulmonary obstructive or restrictive disease
- Diabetic retinopathy
- Acute or chronic inflammation (autoimmune or infectious)
- Significant active / unstable non-malignant disease likely to interfere with study assessments
- Laboratory tests (hematology, chemistry) outside specified limits:
- WBC = 3 x 1000/ mm3
- ANC = 1.5 x 1000/mm3
- Platelets = 100.000 / mm3
- Hb = 9.0 g/dl (= 5.6 mmol/l)
- PT/PTT > 1.5 x ULN
- Serum creatinine > 2.0 mg/dl (> 176.8 mmol/l)
- AST and/or ALT > 5 x ULN
- Alkaline phosphatase > 2 x ULN
- Total bilirubin > 2 x ULN
- Immunotherapy < 6 weeks prior to enrollment
- Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
- Any radiotherapy for pancreatic adenocarcinoma before enrollment except for treatment of bone metastases if target lesions are not included in the irradiated field
- Major surgery < 4 weeks prior to enrollment
- Pregnant or nursing
- Investigational medicinal product < 4 weeks of enrollment
- HIV history
- Hypersensitivity to any component of the EndoTAG™-1 and/or gemcitabine formulations
- History of significant liver pathology (other than metastases)· History of malignancy other than pancreatic cancer < 5 years prior to enrollment, except skin cancer treated locally
- Vulnerable populations (e.g. subjects incapable of giving consent personally



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
MedDRA version: 8.1 Level: LLT Classification code 10052747 Term: Adenocarcinoma pancreas

Intervention(s)

Product Name: EndoTAG-1
Product Code: MDG.09.101
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Paclitaxel
CAS Number: 33069-62-4
Current Sponsor code: MDG.09.100
Other descriptive name: Semi-synthetic Paclitaxel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6.4-

Trade Name: Gemzar®
Product Name: Gemzar®
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Gemcitabine
CAS Number: 122111-03-9
Current Sponsor code: Gemcitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Primary end point(s): Efficacy Endpoints
- Median progression free survival (PFS)
- 6-month-survival-rate calculated by the rate of patients alive 6 months after start of treatment
- Median overall survival (OS)
- Tumor Response (CR / PR / SD / PD) after 14 applications of EndoTAG™-1 and 7 applications of gemcitabine (1 cycle) assessed by the following variables: CT/MRI scans, chest X-ray and CA19-9 level kinetics
- Clinical Benefit via Assessment of Quality of Life (QoL): EORTC-QoL-C30-Questionnaire + PAN-26-module
- Pain assessment (Visual analogue scale = VAS)
- ECOG: Number of patients with improvement/ steady state/ deterioration at week 8 compared to baseline
- CA 19-9: Number of subjects with increase/no change/decrease between baseline and end of treatment, number of subjects within the normal range at baseline and at end of treatment

Safety endpoints
- Adverse Events: Incidence and percentage of patients with treatment emergent AEs
- Laboratory Values: Number of clinically significant abnormal laboratory values
- Dose variations: Percentage of patients having dose reductions/ pausing or discontinuations of gemcitabine and/or EndoTAG™-1

Main Objective: Safety Objectives:
- Assessment of the safety of biweekly infusions of EndoTAG™-1 and weekly infusions of gemcitabine via:
- Incidence and percentage with patients EndoTAG™-1 and gemcitabine related AE
- Laboratory abnormalities (hematology, coagulation parameters, clinical chemistry, urine analysis)
- Dose reductions, pausing and/or discontinuations of EndoTAG™-1 and/or gemcitabine

Efficacy Objectives:
- Assessment of survival (progression free survival, 6-month survival rate, overall survival)
- Tumor response evaluation after 14 applications of EndoTAG™-1 and 7 applications of gemcitabine, i.e. 1 week after last treatment and according to follow-up plan
- Clinical Benefit Assessment via Quality of Life (QoL) Scale (EORTC-QoL-C30-Questionnaire, PAN-26-module)
- Assessment of clinical status via ECOG Scale

Secondary Objective: none

Secondary ID(s)

2005-000666-39-DE

CT 4001

N/A