Metastatic Pancreatic Cancer
Conditions
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 unique dosing regimen that was found to be effective and advantageous in terms of safety. The product is formulated as an oral suspension, conveniently administrated by the patients at home and not requiring medical staff assistance. This Phase II clinical trial aims to evaluate the efficacy, safety and tolerability of TL-118 in Gemcitabine treated Pancreatic Cancer patients
Interventions
DRUGTL-118
TL-118 investigational product is supplied as an oral liquid for daily administration at a specific dosing regimen. Treatment protocol includes weekly therapy cycles.
DRUGGemcitabine
Monthly cycles of 3 weekly treatments a month and one week off of treatment
Sponsors
Technostat
Novatrials
Tiltan Pharma Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 screening 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 C 10. Circumstances likely to interfere with absorption of orally administrated drugs. 11. History of noncompliance to medical regimens or coexisting -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 16 weeks after treatment initiation |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate | Measured at week 16 |
| Quality of life | Baseline to study completion |
| Progression free survival | Measured at week 16 and 52 |
| Overall Survival | Measured at week 16 and 52 |
Countries
Israel, United States
Outcome results
None listed