Status:
UNKNOWN
A Clinical Trial of Anti-Angiogenic Drug Combination Tl-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment
Lead Sponsor:
Tiltan Pharma Ltd.
Collaborating Sponsors:
Technostat
Novatrials
Conditions:
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
TL-118 is an anti-angiogenic drug combination designed for the treatment of cancer. The investigational product Tl-118 comprises of four well-known active components. The therapy is administrated at a...
Eligibility Criteria
Inclusion
- Age at least 18 years at enrollment.
- Metastatic Pancreatic Cancer
- The patient has histologically or cytologically confirmed pancreatic adenocarcinoma.
- Patient has measurable disease by (RECIST).
- Patient is starting standard of care Gemcitabine treatment
- ECOG performance status ≤ 1
- Adequate renal function
- Adequate hepatic function
- Adequate bone marrow reserve
- Resolution of prior therapy acute adverse events.
- Patient is capable of swallowing.
- Patient's Informed Consent. -
Exclusion
- Hypersensitivity to one or more of the TL-118 active components
- Known Glucose-6-phosphate-dehydrogenase deficiency (G6PD).
- CNS or Brain metastases
- Prior systemic therapy for pancreas cancer
- Subjects who received any investigational medication, prior local therapy for pancreas cancer , or any significant change in treatment within 1 month prior to screening
- Concurrent use of any other investigational product
- Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
- Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
- Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C
- Circumstances likely to interfere with absorption of orally administrated drugs.
- History of noncompliance to medical regimens or coexisting -
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01509911
Start Date
January 1 2012
End Date
January 1 2017
Last Update
February 5 2016
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Emory Clinic
Atlanta, Georgia, United States, 30322
2
White Plains Hospital
White Plains, New York, United States, 10601
3
Assaf Harofe Medical Center
Ẕerifin, Zerifin, Israel, 70300
4
HaEmek Medical Center
Afula, Israel