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Phase 2
18 Years
Open (Enrolling)
Metastatic Pancreatic Cancer

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Trial Information

Inclusion Criteria:

1. Age at least 18 years at enrollment.

2. Metastatic Pancreatic Cancer

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

4. Patient has measurable disease by (RECIST).

5. Patient is starting standard of care Gemcitabine treatment

6. ECOG performance status ≤ 1

7. Adequate renal function

8. Adequate hepatic function

9. Adequate bone marrow reserve

10. Resolution of prior therapy acute adverse events.

11. Patient is capable of swallowing.

12. 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. CNS or Brain metastases

4. Prior systemic therapy for pancreas cancer

5. Subjects who received any investigational medication, prior local therapy for
pancreas cancer , or any significant change in treatment within 1 month prior to

6. Concurrent use of any other investigational product

7. Subjects with a clinically significant or unstable medical condition that would
preclude safe and complete study participation

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

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

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

11. History of noncompliance to medical regimens or coexisting -

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease Control Rate as defined by Percentage of patients experiencing a Complete Response or a Partial Response or a Stable Disease according to RECIST measured at 16 weeks after treatment initiation

Outcome Time Frame:

16 weeks after treatment initiation

Safety Issue:



Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:




Start Date:

January 2012

Completion Date:

January 2014

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Pancreatic Neoplasms



White Plains Hospital White Plains, New York  10601