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Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

Inclusion Criteria:

1. Age at least 18 years at enrollment.

2. Locally Advanced Pancreatic Cancer and/or Metastatic Pancreatic Cancer which failed
to respond to one or two lines of chemotherapy

3. The patient has histologically or cytologically confirmed pancreatic cancer.

4. Patient has measurable disease by radiological imaging techniques as defined
according to Response Evaluation Criteria in Solid Tumors (RECIST).

5. ECOG performance status ≤ 2

6. Adequate renal function.

7. Adequate hepatic function

8. Adequate bone marrow reserve -

9. Resolution of prior therapy acute adverse events.

10. Patient is capable of swallowing.

11. Patient's Informed Consent.

Exclusion Criteria:

1. Hypersensitivity to one or more of the TL-118 active components

2. Known Glucose-6-phosphate-dehydrogenase deficiency (G6PD).

3. Known CNS or Brain metastases

4. Patient has received 3 or more different prior chemotherapies for the treatment of
pancreatic cancer

5. Any significant change in treatment within the 14 days before screening or an
un-stable medical condition that may affect patient participation or evaluation in
the study.

6. Concurrent use of any other investigational product or within 28 days before study

7. Chronic treatment with: (a) immunosuppressive agent other than systemic
corticosteroid, (b) patients who are under chronic treatment with NSAIDs with the
exception of Aspirin at a daily dose ≤ 100mg.

8. Use of supplements or complementary medicines/botanicals, except for conventional
multivitamin supplements, calcium, selenium and soy supplements.

9. Patients at increased risk of gastro intestinal bleeding such as patients with known
active gastro intestinal ulcer, erosive gastritis or varices, as confirmed by
gastroscopy performed within one year before screening.

10. Serious or uncontrolled co-existent diseases that are likely to significantly
increase the risks associated with TL-118 therapy (e.g. severe cardiovascular
disease, congestive heart failure, recent myocardial infarction, significant vascular
disease, active or uncontrolled autoimmune disease, active or uncontrolled

11. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis

12. Serious or non-healing wound, ulcer or bone fracture.

13. Circumstances likely to interfere with absorption of orally administrated drugs.

14. History of noncompliance to medical regimens or coexisting conditions precluding full
compliance with study protocol, or any other condition that in the discretion of the
Investigator may preclude safe and complete study participation.

15. Subjects unwilling or unable to comply with study protocol.

16. Know pregnancy or breast-feeding women.

17. Women of child bearing potential not exercising two methods of contraception.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Benefit Measurement

Outcome Description:

Clinical Benefit Measurement is a composite of measurements of pain (analgesic consumption and pain intensity), performance status and weight. Clinical benefit requires an improvement in at least one parameter, without worsening in any others, sustained for at least 4 weeks

Outcome Time Frame:

Baseline up to 2 years

Safety Issue:



Israel: Ministry of Health

Study ID:




Start Date:

August 2012

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • Patients
  • Pancreatic Neoplasms