Safety, pharmacokinetics and efficacy of AXP107-11 in combination with standard gemcitabine (Gemzar®) treatment in patients with locally advanced or metastatic, unresectable, adenocarcinoma of the pancreas, stage III-IV. A prospective, open label, multi-centre, sequential phase Ib/IIa study.

Phase 1

• Conditions: MedDRA version: 16.0Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864; Histologically confirmed, unresectable, locally advanced or metastatic pancreatic cancer stage III-IV; MedDRA version: 16.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-019214-25-SE
• Lead Sponsor: Axcentua Pharmaceuticals AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-06
• Study Completion: 2014-12-07
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Inclusion criteria
1. Age = 18 years at the time of signing the informed consent
2. Histologically confirmed adenocarcinoma of the pancreas
3. Metastatic or locally advanced, unresectable disease stage III-IV.
4. Measurable disease according to the international criteria proposed by the Response Evaluation Criteria in Solid tumors (RECIST) for target lesions
5. Karnofsky Performance Status = 70 at study entry (Appendix 18.4).
6. Life expectancy of more than three months
7. Negative pregnancy test for female patients
8. For fertile women, willingness to perform double-barrier contraception during study and for four weeks after last treatment
9. Able and willing to sign the informed consent form
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

Exclusion criteria
1. Previous or ongoing severe supraventricular or ventricular arrhythmia
2. Previous or ongoing coagulation or bleeding disorder (PTT > 1.5 x ULN)
3. HIV infection
4. Known hypersensitivity to any component of the AXP107-11 formulation or gemcitabine
5. Previous or ongoing significant liver pathology (other than metastases) and/or liver function disorders
6. Previous or ongoing significant chronic renal dysfunction
7. Previous or ongoing malignancy other than pancreatic cancer < five years prior to enrolment, except basal cell carcinoma treated locally
8. Cardiovascular disease, New York Heart Association (NYHA) classification III or IV
9. Severe pulmonary obstructive or restrictive disease
10. Acute or chronic inflammation (autoimmune or infectious)
11. Significant active/unstable non-malignant disease likely to interfere with study assessments
12. Laboratory tests (hematology, chemistry) outside specified limits:
-WBC = 3 x 10³/mm³
-ANC = 1.5 x 10³/mm³
-Platelets = 100.000/mm³
-Hb = 9.0 g/dl (= 5.6 mmol/l)
-PT/PTT > 3 x ULN
-Serum creatinine > 130 µmol/l) or clearance < 60 ml/min
-AST and/or ALT > 3 x ULN with the exception of patients with liver metastasis (> 5 x ULN)
-Alkaline phosphatase > 3 x ULN
-Total bilirubin > 3 x ULN

13. Immunotherapy within six weeks prior to enrolment.
14. Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrolment
15. Any radiotherapy for pancreatic adenocarcinoma before enrolment except for treatment of bone metastases if target lesions are not included in the irradiated field
16. Major surgery within four weeks prior to enrolment
17. Pregnant or nursing woman
18. Participations in other interventional clinical study within four weeks of enrolment

Study & Design

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