AXP107-11 in Combination With Standard Gemcitabine (Gemzar® ) Therapy for Treatment in Patients With Pancreatic Cancer

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effect and safety of AXP107-11 alone, and in combination with gemcitabine standard therapy, in patients with advanced or metastatic cancer of the pancreas. The safety, pharmacokinetics and efficacy of AXP107-11 in these patients will also be studied.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axcentua Pharmaceuticals AB
• Treatments: Gemcitabine; Genistein

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

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 IV16

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 > 1.5 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